Sample records for safety communication fda
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Directory of Open Access Journals (Sweden)
Bander Balkhi
2018-02-01
Conclusions: The 2010 FDA bisphosphonates safety communication appeared to have influenced Osteoporosis utilization in Medicaid recipients. The 2010 FDA bisphosphonates safety communication was associated with a significant reduction in the utilization of bisphosphonates in the Medicaid program.
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FDA drug safety communications: a narrative review and clinical considerations for older adults.
Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A
2012-08-01
The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older
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Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014
Directory of Open Access Journals (Sweden)
Benjamin Hixon
2017-02-01
Full Text Available Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC. The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9% of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%. The three most frequently reported labeling changes were warnings (68.7%, precautions (58.6%, and patient package insert/medication guide (23.2%. Case reports resulted in the greatest number of documented literature types (n = 791, followed by randomized controlled trials (n = 76, and case control/cohort studies (n = 74. Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%, compared to LOE A (17.1%, and LOE C (14.1% (p = 0.007. Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties. Type: Original Research
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Stone, Benjamin V; Forde, James C; Levit, Valerie B; Lee, Richard K; Te, Alexis E; Chughtai, Bilal
2016-11-01
In July 2011, the US Food and Drug Administration (FDA) issued a safety communication regarding serious complications associated with surgical mesh for pelvic organ prolapse, prompting increased media and public attention. This study sought to analyze internet search activity and news article volume after this FDA warning and to evaluate the quality of websites providing patient-centered information. Google Trends™ was utilized to evaluate search engine trends for the term "pelvic organ prolapse" and associated terms between 1 January 2004 and 31 December 2014. Google News™ was utilized to quantify the number of news articles annually under the term "pelvic organ prolapse." The search results for the term "pelvic organ prolapse" were assessed for quality using the Health On the Net Foundation (HON) certification. There was a significant increase in search activity from 37.42 in 2010 to 57.75 in 2011, at the time of the FDA communication (p = 0.021). No other annual interval had a statistically significant increase in search activity. The single highest monthly search activity, given the value of 100, was August 2011, immediately following the July 2011 notification, with the next highest value being 98 in July 2011. Linear regression analysis of news articles per year since the FDA communication revealed r 2 = 0.88, with a coefficient of 186. Quality assessment demonstrated that 42 % of websites were HON-certified, with .gov sites providing the highest quality information. Although the 2011 FDA safety communication on surgical mesh was associated with increased public and media attention, the quality of relevant health information on the internet remains of poor quality. Future quality assurance measures may be critical in enabling patients to play active roles in their own healthcare.
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2013-03-05
... FDA's Product Tracing Web page at http://www.fda.gov/Food/FoodSafety/FSMA/ucm270851.htm . This... Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Request for Comments and... Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food...
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Murphy, Miles; Holzberg, Adam; van Raalte, Heather; Kohli, Neeraj; Goldman, Howard B; Lucente, Vincent
2012-01-01
In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996-2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.
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Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton
2012-01-01
Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.
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MedWatch, the FDA Safety Information and Adverse Event Reporting Program
... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it ... approved information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety ...
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Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen
2014-01-01
The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications. © 2013 Pharmacotherapy Publications, Inc.
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The FDA Food Safety and Modernization Act and the Exemption for Small Firms
Pouliot, Sebastien
2011-01-01
The FDA Food Safety Modernization Act of 2010 is new legislation that mandates, among other things, new food safety standards. The act includes a clause that exempts small firms from new regulatory requirements. This paper investigates the effects of a small firm exemption from more stringent food safety standards. The model compares food safety, total output and the number of market participants for different food safety regulation with and without an exemption for small firms. The numerical...
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2011-10-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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FDA actions against health economic promotions, 2002-2011.
Neumann, Peter J; Bliss, Sarah K
2012-01-01
To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading. We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act. Of 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114. The FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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2011-03-14
... Act: Title III--A New Paradigm for Importers; Public Meeting AGENCY: Food and Drug Administration, HHS... announcing a public meeting entitled ``FDA Food Safety Modernization Act: Title III--A New Paradigm for... provided. Request special accommodations due By March 22, 2011.... Patricia M. Kuntze, 301- to disability...
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Drugs@FDA: FDA Approved Drug Products
... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...
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Chen, Brian K; Yang, Y Tony; Cheng, Xi; Bian, John; Bennett, Charles L
2016-01-01
The United States Constitution protects the right of citizens to petition the government for "a redress of grievances." This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10-13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to "redress grievances."
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Network-Based Real-time Integrated Fire Detection and Alarm (FDA) System with Building Automation
Anwar, F.; Boby, R. I.; Rashid, M. M.; Alam, M. M.; Shaikh, Z.
2017-11-01
Fire alarm systems have become increasingly an important lifesaving technology in many aspects, such as applications to detect, monitor and control any fire hazard. A large sum of money is being spent annually to install and maintain the fire alarm systems in buildings to protect property and lives from the unexpected spread of fire. Several methods are already developed and it is improving on a daily basis to reduce the cost as well as increase quality. An integrated Fire Detection and Alarm (FDA) systems with building automation was studied, to reduce cost and improve their reliability by preventing false alarm. This work proposes an improved framework for FDA system to ensure a robust intelligent network of FDA control panels in real-time. A shortest path algorithmic was chosen for series of buildings connected by fiber optic network. The framework shares information and communicates with each fire alarm panels connected in peer to peer configuration and declare the network state using network address declaration from any building connected in network. The fiber-optic connection was proposed to reduce signal noises, thus increasing large area coverage, real-time communication and long-term safety. Based on this proposed method an experimental setup was designed and a prototype system was developed to validate the performance in practice. Also, the distributed network system was proposed to connect with an optional remote monitoring terminal panel to validate proposed network performance and ensure fire survivability where the information is sequentially transmitted. The proposed FDA system is different from traditional fire alarm and detection system in terms of topology as it manages group of buildings in an optimal and efficient manner.Introduction
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Strauss, Debra M
2011-01-01
This article analyzes components of the FDA Food Safety Modernization Act, which was prompted by incidents of food contamination, exploring the history of its passage and explaining its significance, as well as its limitations. As the first time in 70 years that food law has been changed substantially, this new law represents only an initial but significant step in the direction of improving food safety. With bipartisan support from both Congress and the President, this legislation embodies a mandate that food safety is at this moment becoming a priority. As a result, the time is ripe for a reassessment of other areas of food laws--particularly genetically modified foods and the use of milk and meat from cloned animals and their progeny--which are allowed under current U.S. law with no labeling, preapprovals, or post-market monitoring. These areas warrant special regulation consistent with the new proactive policy towards securing the safety of the food supply.
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Leader communication approaches and patient safety: An integrated model.
Mattson, Malin; Hellgren, Johnny; Göransson, Sara
2015-06-01
Leader communication is known to influence a number of employee behaviors. When it comes to the relationship between leader communication and safety, the evidence is more scarce and ambiguous. The aim of the present study is to investigate whether and in what way leader communication relates to safety outcomes. The study examines two leader communication approaches: leader safety priority communication and feedback to subordinates. These approaches were assumed to affect safety outcomes via different employee behaviors. Questionnaire data, collected from 221 employees at two hospital wards, were analyzed using structural equation modeling. The two examined communication approaches were both positively related to safety outcomes, although leader safety priority communication was mediated by employee compliance and feedback communication by organizational citizenship behaviors. The findings suggest that leader communication plays a vital role in improving organizational and patient safety and that different communication approaches seem to positively affect different but equally essential employee safety behaviors. The results highlights the necessity for leaders to engage in one-way communication of safety values as well as in more relational feedback communication with their subordinates in order to enhance patient safety. Copyright © 2015 Elsevier Ltd. and National Safety Council. Published by Elsevier Ltd. All rights reserved.
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Teaching the science of safety in US colleges and schools of pharmacy.
Holdford, David A; Warholak, Terri L; West-Strum, Donna; Bentley, John P; Malone, Daniel C; Murphy, John E
2011-05-10
This paper provides baseline information on integrating the science of safety into the professional degree curriculum at colleges and schools of pharmacy. A multi-method examination was conducted that included a literature review, key informant interviews of 30 individuals, and in-depth case studies of 5 colleges and schools of pharmacy. Educators believe that they are devoting adequate time to science of safety topics and doing a good job teaching students to identify, understand, report, manage, and communicate medication risk. Areas perceived to be in need of improvement include educating pharmacy students about the Food and Drug Administration's (FDA's) role in product safety, how to work with the FDA in post-marketing surveillance and other FDA safety initiatives, teaching students methods to improve safety, and educating students to practice in interprofessional teams. The report makes 10 recommendations to help pharmacy school graduates be more effective in protecting patients from preventable drug-related problems.
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Improving Patient Safety: Improving Communication.
Bittner-Fagan, Heather; Davis, Joshua; Savoy, Margot
2017-12-01
Communication among physicians, staff, and patients is a critical element in patient safety. Effective communication skills can be taught and improved through training and awareness. The practice of family medicine allows for long-term relationships with patients, which affords opportunities for ongoing, high-quality communication. There are many barriers to effective communication, including patient factors, clinician factors, and system factors, but tools and strategies exist to address these barriers, improve communication, and engage patients in their care. Use of universal precautions for health literacy, appropriate medical interpreters, and shared decision-making are evidence-based tools that improve communication and increase patient safety. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.
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Groves, Patricia S; Bunch, Jacinda L
2018-05-18
The aim of this paper is discussion of a new middle-range theory of patient safety goal priming via safety culture communication. Bedside nurses are key to safe care, but there is little theory about how organizations can influence nursing behavior through safety culture to improve patient safety outcomes. We theorize patient safety goal priming via safety culture communication may support organizations in this endeavor. According to this theory, hospital safety culture communication activates a previously held patient safety goal and increases the perceived value of actions nurses can take to achieve that goal. Nurses subsequently prioritize and are motivated to perform tasks and risk assessment related to achieving patient safety. These efforts continue until nurses mitigate or ameliorate identified risks and hazards during the patient care encounter. Critically, this process requires nurses to have a previously held safety goal associated with a repertoire of appropriate actions. This theory suggests undergraduate educators should foster an outcomes focus emphasizing the connections between nursing interventions and safety outcomes, hospitals should strategically structure patient safety primes into communicative activities, and organizations should support professional development including new skills and the latest evidence supporting nursing practice for patient safety. © 2018 John Wiley & Sons Ltd.
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... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...
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Improving construction site safety through leader-based verbal safety communication.
Kines, Pete; Andersen, Lars P S; Spangenberg, Soren; Mikkelsen, Kim L; Dyreborg, Johnny; Zohar, Dov
2010-10-01
The construction industry is one of the most injury-prone industries, in which production is usually prioritized over safety in daily on-site communication. Workers have an informal and oral culture of risk, in which safety is rarely openly expressed. This paper tests the effect of increasing leader-based on-site verbal safety communication on the level of safety and safety climate at construction sites. A pre-post intervention-control design with five construction work gangs is carried out. Foremen in two intervention groups are coached and given bi-weekly feedback about their daily verbal safety communications with their workers. Foremen-worker verbal safety exchanges (experience sampling method, n=1,693 interviews), construction site safety level (correct vs. incorrect, n=22,077 single observations), and safety climate (seven dimensions, n=105 questionnaires) are measured over a period of up to 42 weeks. Baseline measurements in the two intervention and three control groups reveal that foremen speak with their workers several times a day. Workers perceive safety as part of their verbal communication with their foremen in only 6-16% of exchanges, and the levels of safety at the sites range from 70-87% (correct observations). Measurements from baseline to follow-up in the two intervention groups reveal that safety communication between foremen and workers increases significantly in one of the groups (factor 7.1 increase), and a significant yet smaller increase is found when the two intervention groups are combined (factor 4.6). Significant increases in the level of safety are seen in both intervention groups (7% and 12% increases, respectively), particularly in regards to 'access ways' and 'railings and coverings' (39% and 84% increases, respectively). Increases in safety climate are seen in only one of the intervention groups with respect to their 'attention to safety.' No significant trend changes are seen in the three control groups on any of the three measures
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Regulating nanomedicine - can the FDA handle it?
Bawa, Raj
2011-05-01
There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle
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Communication's Role in Safety Management and Performance for the Road Safety Practices
Salim Keffane (s)
2014-01-01
Communication among organizations could play an important role in increasing road safety. To get in-depth knowledge of its role, this study measured managers' and employees' perceptions of the communication's role on six safety management and performance criteria for road safety practices by conducting a survey using a questionnaire among 165 employees and 135 managers. Path analysis using AMOS-19 software shows that some of the safety management road safety practices have high correlation wi...
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Functional Safety Specification of Communication Profile PROFIsafe
Directory of Open Access Journals (Sweden)
Jan Rofar
2006-01-01
Full Text Available Paper maps the trends in area of safety-related communication within PROFIBUS and PROFINET industry networks. There are analyses safety measures and Fail-safe parameters of PROFIsafe profile in version V2 and their localisation in Safety Communication Layer SCL, which guarantees Safety Integrity Level SIL according to standard IEC 61508. The last chapter analyses the reaction in the event of fault during transmission of messages.
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Quantitative Safety and Security Analysis from a Communication Perspective
Directory of Open Access Journals (Sweden)
Boris Malinowsky
2015-12-01
Full Text Available This paper introduces and exemplifies a trade-off analysis of safety and security properties in distributed systems. The aim is to support analysis for real-time communication and authentication building blocks in a wireless communication scenario. By embedding an authentication scheme into a real-time communication protocol for safety-critical scenarios, we can rely on the protocol’s individual safety and security properties. The resulting communication protocol satisfies selected safety and security properties for deployment in safety-critical use-case scenarios with security requirements. We look at handover situations in a IEEE 802.11 wireless setup between mobile nodes and access points. The trade-offs involve application-layer data goodput, probability of completed handovers, and effect on usable protocol slots, to quantify the impact of security from a lower-layer communication perspective on the communication protocols. The results are obtained using the network simulator ns-3.
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Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.
Sage, Adam; Blalock, Susan J; Carpenter, Delesha
This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.
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Comparison of FDA safety and efficacy data for KAMRA and Raindrop corneal inlays
Directory of Open Access Journals (Sweden)
Majid Moshirfar
2017-09-01
Full Text Available AIM: To provide a side-by-side analysis of the summary of safety and effectiveness data (SSED submitted to the FDA for the KAMRA and Raindrop corneal inlays for the correction of presbyopia. METHODS: SSED reports submitted to the FDA for KAMRA and Raindrop were compared with respect to loss of corrected distance visual acuity (CDVA, adverse event rates, induction of astigmatism, retention of contrast sensitivity, stability of manifest refractive spherical equivalent (MRSE, and achieved monocular uncorrected near visual acuity (UNVA at 24mo. RESULTS: Totally 442/508 of KAMRA patients and 344/373 Raindrop patients remained enrolled in the clinical trials at 24mo. The proportion of KAMRA and Raindrop patients who lost ≥2 lines of CDVA at 24mo was 3.4% and 1%, respectively. The adverse event rate was comparable between the devices. No significant inductions of astigmatism were noted. Both technologies induced a transient myopic shift in MRSE followed by a hyperopic shift and subsequent stabilization. Totally 87% of KAMRA and 98% of Raindrop patients attained a monocular UNVA of J5 (20/40 or better at 24mo, 28% of KAMRA and 67% of Raindrop patients attained a monocular UNVA of J1 (20/20 or better at 24mo. CONCLUSION: Both devices can be considered safe and effective, however, the results of corneal inlay implantation are mixed, and long-term patient satisfaction will likely depend on subjective expectations about the capabilities of the inlays. Variability in surgical technique and postoperative care within and between the two clinical trials diminishes the comparative power of this article.
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Safety and communication, a winning combination
HSE Unit
2014-01-01
Since 2013, in line with its mission to support CERN’s proactive communication policy in matters of safety, the HSE unit has been following an annual plan for disseminating information on occupational health and safety and environmental protection. Safety information designed to underline the importance of prevention is published through a variety of channels: Announcements in the CERN Bulletin, Safety bulletins, notably outlining lessons to be learned in the wake of accidents/incidents occuring at CERN, Safety alerts calling for immediate action, sent by e-mail to the services concerned, Prevention campaigns on the CERN site, Poster campaigns in well frequented public areas. Photo: Christoph Balle. Please heed all prevention messages and apply them in your everyday life. Also, we will be pleased to receive any information or suggestions you may have on safety matters. If you have questions about the HSE unit’s communication activities, please send us an e...
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47 CFR 80.1109 - Distress, urgency, and safety communications.
2010-10-01
... 47 Telecommunication 5 2010-10-01 2010-10-01 false Distress, urgency, and safety communications. 80.1109 Section 80.1109 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS...
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Safety and Nonsafety Communications and Interactions in International Nuclear Power Plants
Energy Technology Data Exchange (ETDEWEB)
Kisner, Roger A [ORNL; Mullens, James Allen [ORNL; Wilson, Thomas L [ORNL; Wood, Richard Thomas [ORNL; Korsah, Kofi [ORNL; Qualls, A L [ORNL; Muhlheim, Michael David [ORNL; Holcomb, David Eugene [ORNL; Loebl, Andy [ORNL
2007-08-01
Current industry and NRC guidance documents such as IEEE 7-4.3.2, Reg. Guide 1.152, and IEEE 603 do not sufficiently define a level of detail for evaluating interdivisional communications independence. The NRC seeks to establish criteria for safety systems communications that can be uniformly applied in evaluation of a variety of safety system designs. This report focuses strictly on communication issues related to data sent between safety systems and between safety and nonsafety systems. Further, the report does not provide design guidance for communication systems nor present detailed failure modes and effects analysis (FMEA) results for existing designs. This letter report describes communications between safety and nonsafety systems in nuclear power plants outside the United States. A limited study of international nuclear power plants was conducted to ascertain important communication implementations that might have bearing on systems proposed for licensing in the United States. This report provides that following information: 1.communications types and structures used in a representative set of international nuclear power reactors, and 2.communications issues derived from standards and other source documents relevant to safety and nonsafety communications. Topics that are discussed include the following: communication among redundant safety divisions, communications between safety divisions and nonsafety systems, control of safety equipment from a nonsafety workstation, and connection of nonsafety programming, maintenance, and test equipment to redundant safety divisions during operation. Information for this report was obtained through publicly available sources such as published papers and presentations. No proprietary information is represented.
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Safety and Nonsafety Communications and Interactions in International Nuclear Power Plants
International Nuclear Information System (INIS)
Kisner, Roger A.; Mullens, James Allen; Wilson, Thomas L.; Wood, Richard Thomas; Korsah, Kofi; Qualls, A.L.; Muhlheim, Michael David; Holcomb, David Eugene; Loebl, Andy
2007-01-01
Current industry and NRC guidance documents such as IEEE 7-4.3.2, Reg. Guide 1.152, and IEEE 603 do not sufficiently define a level of detail for evaluating interdivisional communications independence. The NRC seeks to establish criteria for safety systems communications that can be uniformly applied in evaluation of a variety of safety system designs. This report focuses strictly on communication issues related to data sent between safety systems and between safety and nonsafety systems. Further, the report does not provide design guidance for communication systems nor present detailed failure modes and effects analysis (FMEA) results for existing designs. This letter report describes communications between safety and nonsafety systems in nuclear power plants outside the United States. A limited study of international nuclear power plants was conducted to ascertain important communication implementations that might have bearing on systems proposed for licensing in the United States. This report provides that following information: 1.communications types and structures used in a representative set of international nuclear power reactors, and 2.communications issues derived from standards and other source documents relevant to safety and nonsafety communications. Topics that are discussed include the following: communication among redundant safety divisions, communications between safety divisions and nonsafety systems, control of safety equipment from a nonsafety workstation, and connection of nonsafety programming, maintenance, and test equipment to redundant safety divisions during operation. Information for this report was obtained through publicly available sources such as published papers and presentations. No proprietary information is represented
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Sinha, Michael S; Freifeld, Clark C; Brownstein, John S; Donneyong, Macarius M; Rausch, Paula; Lappin, Brian M; Zhou, Esther H; Dal Pan, Gerald J; Pawar, Ajinkya M; Hwang, Thomas J; Avorn, Jerry; Kesselheim, Aaron S
2018-01-05
The Food and Drug Administration (FDA) issues drug safety communications (DSCs) to health care professionals, patients, and the public when safety issues emerge related to FDA-approved drug products. These safety messages are disseminated through social media to ensure broad uptake. The objective of this study was to assess the social media dissemination of 2 DSCs released in 2013 for the sleep aid zolpidem. We used the MedWatcher Social program and the DataSift historic query tool to aggregate Twitter and Facebook posts from October 1, 2012 through August 31, 2013, a period beginning approximately 3 months before the first DSC and ending 3 months after the second. Posts were categorized as (1) junk, (2) mention, and (3) adverse event (AE) based on a score between -0.2 (completely unrelated) to 1 (perfectly related). We also looked at Google Trends data and Wikipedia edits for the same time period. Google Trends search volume is scaled on a range of 0 to 100 and includes "Related queries" during the relevant time periods. An interrupted time series (ITS) analysis assessed the impact of DSCs on the counts of posts with specific mention of zolpidem-containing products. Chow tests for known structural breaks were conducted on data from Twitter, Facebook, and Google Trends. Finally, Wikipedia edits were pulled from the website's editorial history, which lists all revisions to a given page and the editor's identity. In total, 174,286 Twitter posts and 59,641 Facebook posts met entry criteria. Of those, 16.63% (28,989/174,286) of Twitter posts and 25.91% (15,453/59,641) of Facebook posts were labeled as junk and excluded. AEs and mentions represented 9.21% (16,051/174,286) and 74.16% (129,246/174,286) of Twitter posts and 5.11% (3,050/59,641) and 68.98% (41,138/59,641) of Facebook posts, respectively. Total daily counts of posts about zolpidem-containing products increased on Twitter and Facebook on the day of the first DSC; Google searches increased on the week of the
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Communication elements supporting patient safety in psychiatric inpatient care.
Kanerva, A; Kivinen, T; Lammintakanen, J
2015-06-01
Communication is important for safe and quality health care. The study provides needed insight on the communication elements that support patient safety from the psychiatric care view. Fluent information transfer between the health care professionals and care units is important for care planning and maintaining practices. Information should be documented and implemented accordingly. Communication should happen in an open communication culture that enables discussion, the opportunity to have debriefing discussions and the entire staff can feel they are heard. For effective communication, it is also important that staff are active themselves in information collecting about the essential information needed in patient care. In mental health nursing, it is important to pay attention to all elements of communication and to develop processes concerning communication in multidisciplinary teams and across unit boundaries. The study aims to describe which communication elements support patient safety in psychiatric inpatient care from the viewpoint of the nursing staff. Communication is an essential part of care and one of the core competencies of the psychiatric care. It enables safe and quality patient care. Errors in health care are often connected with poor communication. The study brings needed insight from the psychiatric care view to the topic. The data were gathered from semi-structured interviews in which 26 nurses were asked to describe the elements that constitute patient safety in psychiatric inpatient care. The data were analysed inductively from the viewpoint of communication. The descriptions connected with communication formed a main category of communication elements that support patient safety; this main category was made up of three subcategories: fluent information transfer, open communication culture and being active in information collecting. Fluent information transfer consists of the practical implementation of communication; open communication
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Lyons, Vanessa E; Popejoy, Lori L
2014-02-01
The purpose of this study is to examine the effectiveness of surgical safety checklists on teamwork, communication, morbidity, mortality, and compliance with safety measures through meta-analysis. Four meta-analyses were conducted on 19 studies that met the inclusion criteria. The effect size of checklists on teamwork and communication was 1.180 (p = .003), on morbidity and mortality was 0.123 (p = .003) and 0.088 (p = .001), respectively, and on compliance with safety measures was 0.268 (p teamwork and communication, reduce morbidity and mortality, and improve compliance with safety measures. This meta-analysis is limited in its generalizability based on the limited number of studies and the inclusion of only published research. Future research is needed to examine possible moderating variables for the effects of surgical safety checklists.
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Communication of geo-scientific safety arguments
International Nuclear Information System (INIS)
Flavelle, P.; Goodwin, B.; Jensen, M.; Linden, R.; Mazurek, M.; Srivastave, M.; Strom, A.; Sudicky, E.; Voinis, S.
2007-01-01
Working Group B addressed the communication of geo-scientific safety arguments through a discussion of practical experience as it related to the methods, types of information and specific arguments found to best communicate geo-scientific concepts and notions of safety with broad audiences including, colleagues, authorities and regulators, political decision makers, academics, and the general public. The following questions were suggested by the programme committee of the AMIGO-2 workshop for discussion by Working Group B with respect to the communication of geo-scientific information and safety arguments: - What is the place of geo-scientific arguments in relation to quantitative and qualitative topics like scenario and FEPs (features, events, processes) assessment, simulated repository evolution, calculated dose or risk impacts, engineering tests of materials, etc., when presenting a safety case to different audiences and with respect to the various stages of the repository programme? (see section 3). - Would we be better off focusing messages to the public on time scales of a few hundred years or a few generations? (see section 4). - How do you handle the fact that geoscience interpretations seldom are unique and data often are open to various interpretations? (see section 5). - How do you handle expert controversy on a specific topic? (see section 6). (authors)
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U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...
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Frequency and Variance of Communication Characteristics in Aviation Safety Events
Karanikas, Nektarios; Kaspers, Steffen
2017-01-01
In the aviation sector, communication problems have contributed into 70% to 80% of safety occurrences. However, to date we haven’t depicted which communication aspects have affected aviation safety most frequently. Based on literature, we developed a tool which includes communication characteristics
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Risk communication activities toward nuclear safety in Tokai: your safety is our safety
International Nuclear Information System (INIS)
Tsuchiya, T.
2007-01-01
As several decades have passed since the construction of nuclear power plants began, residents have become gradually less interested in nuclear safety. The Tokai criticality accident in 1909, however, had roused residents in Tokai-Mura to realize that they live with nuclear technology risks. To prepare a field of risk communication, the Tokai-Mura C 3 project began as a pilot research project supported by NISA. Alter the project ended, we are continuing risk. communication activities as a non-profit organisation. The most important activity of C 3 project is the citizen's inspection programme for nuclear related facilities. This programme was decided by participants who voluntarily applied to the project. The concept of the citizen's inspection programme is 'not the usual facility tours'. Participants are involved from the planning stage and continue to communicate with workers of the inspected nuclear facility. Since 2003, we have conducted six programmes for five nuclear related organisations. Participants evaluated that radiation protection measures were near good but there were some problems concerning the worker's safety and safety culture, and proposed a mixture of advice based on personal experience. Some advice was accepted and it did improve the facility's safety measures. Other suggestions were not agreed upon by nuclear organisations. The reason lies in the difference of concept between the nuclear expert's 'safety' and the citizen's 'safety'. Residents do not worry about radiation only, but also about the facility's safety as a whole including the worker's safety. They say, 'If the workers are not safe, you also are unable to protect us'. Although the disagreement remained, the participants and the nuclear industry learned much about each other. Participating citizens received a substantial amount of knowledge about the nuclear industry and its safety measures, and feel the credibility and openness of the nuclear industry. On the other hand, the nuclear
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Teamwork and communication: an effective approach to patient safety.
Mujumdar, Sandhya; Santos, Diana
2014-01-01
Teamwork and communication failures are leading causes of patient safety incidents in health care. Though health care providers must work in teams, they are not well-trained in teamwork and communication skills. Health care faces the problems of differences in communication styles, communication failures and poor teamwork. There is enough evidence in the literature to show that communication failure is detrimental to patient safety. It is estimated that 80% of serious medical errors worldwide take place because of miscommunication between medical providers. NUH recognizes that effective communication and teamwork are essential in the delivery of high quality safe patient care, especially in a complex organization. NUH is a good example, where there is a rich mix of nationalities and races, in staff and in patients, and there is a rapidly expanding care environment. NUH had to overcome these challenges by adopting a multi-pronged approach. The trials and tribulations of NUH in this journey were worthwhile as the patient safety climate survey scores improved over the years.
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Design requirements of communication architecture of SMART safety system
International Nuclear Information System (INIS)
Park, H. Y.; Kim, D. H.; Sin, Y. C.; Lee, J. Y.
2001-01-01
To develop the communication network architecture of safety system of SMART, the evaluation elements for reliability and performance factors are extracted from commercial networks and classified the required-level by importance. A predictable determinacy, status and fixed based architecture, separation and isolation from other systems, high reliability, verification and validation are introduced as the essential requirements of safety system communication network. Based on the suggested requirements, optical cable, star topology, synchronous transmission, point-to-point physical link, connection-oriented logical link, MAC (medium access control) with fixed allocation are selected as the design elements. The proposed architecture will be applied as basic communication network architecture of SMART safety system
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TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities
International Nuclear Information System (INIS)
2016-01-01
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities
Energy Technology Data Exchange (ETDEWEB)
NONE
2016-06-15
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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Communicating on risk and safety in terms of awareness
International Nuclear Information System (INIS)
Hammar, L.; Andersson, Kjell
1999-01-01
'Safety awareness' is proposed as a possibly constructive concept for the purpose of promoting initiatives in nuclear safety work and gaining improved understanding when communicating on nuclear safety. Safety is thus conceived as resulting essentially from and actually constituting awareness of critical factors in regard of safety. The concept aims specifically at promoting the view of 'safety' as 'awareness of required conditions for being in control of risk'. It aims as well at making clearer sense in calling for constant improvement of safety, according to practice in a safety culture. This proposed view would be expected to lead to applying the usual types of safety criteria but offers the merit of attracting due attention to 'awareness goals' in process oriented safety management which are fundamental to maintaining and improving safety. Applications are discussed in regard of communicating on nuclear safety between decision-makers and the general public, developing and maintaining safety culture, integrating specialist expert contributions in over-all safety assessment, setting safety goals and using safety indicators
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Interface management: Effective communication to improve process safety
International Nuclear Information System (INIS)
Kelly, Brian; Berger, Scott
2006-01-01
Failure to successfully communicate maintenance activities, abnormal conditions, emergency response procedures, process hazards, and hundreds of other items of critical information can lead to disaster, regardless of the thoroughness of the process safety management system. Therefore, a well-functioning process safety program depends on maintaining successful communication interfaces between each involved employee or stakeholder and the many other employees or stakeholders that person must interact with. The authors discuss a process to identify the critical 'Interfaces' between the many participants in a process safety management system, and then to establish a protocol for each critical interface
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FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.
James, J S
1998-03-06
The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.
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IAEA activities on communication of nuclear safety issues
International Nuclear Information System (INIS)
Wieland, P.
2001-01-01
The regulatory authorities in several countries have taken the initiative to overcome the renowned difficulties of communicating nuclear safety issues. They communicate with segments of the public specially in case of nuclear/radiological accidents, waste disposal, transport of radioactive material or food irradiation. This reflects the full recognition of the importance of the topic. However it is also recognized that there is hitherto a need of international assistance in order to develop a regulatory communication strategy that could be harmonized and at the same time customized to the different needs. Communications on nuclear, radiation, transport and radioactive waste safety are needed to: disseminate information on safety to the public in both routine and emergency situations ; be attentive to public concerns, and address them; maintain social trust and confidence by keeping society informed on the established safety standards and how they are enforced; facilitate the decision-making process on nuclear matters by promptly presenting factual information in a clear manner; integrate and maintain an information network at both the national and international levels; improve co-operation with other countries and international organizations; encourage the dissemination of factual information on nuclear issues in schools. A major factor in addressing all of these questions is understanding the audience(s). A two way communication process is needed to establish what particular audiences want to know and in what form they prefer to receive information. This will differ depending on the audience and circumstances. For example, the information on a routine day-to-day basis will be different from what might be needed at the time of an accident. Communication with the news media is a matter of particular importance, as they are both an audience in themselves and a channel for communicating with wider audiences. (author)
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47 CFR 80.1133 - Transmission of safety communications.
2010-10-01
... SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Operating... safety traffic frequencies specified in § 80.1077, or via the maritime mobile satellite service or on... 47 Telecommunication 5 2010-10-01 2010-10-01 false Transmission of safety communications. 80.1133...
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Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?
Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E
2015-10-01
The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.
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DEFF Research Database (Denmark)
Amarilyo, Gil; Furst, Daniel E; Woo, Jennifer M P
2016-01-01
BACKGROUND: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. OBJECTIVES: This study sought to determine if there are differences between the FDA assessments and journal...... reports on biologic agents developed for the treatment of rheumatoid arthritis. METHODS: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American...... College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report...
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FDA toxicity databases and real-time data entry
International Nuclear Information System (INIS)
Arvidson, Kirk B.
2008-01-01
Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared
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International Nuclear Information System (INIS)
Lee, Sang Hun; Son, Kwang Seop; Jung, Wondea; Kang, Hyun Gook
2017-01-01
Highlights: • Safety data communication risk assessment framework and quantitative scheme were proposed. • Fault-tree model of ESFAS unavailability due to safety data communication failure was developed. • Safety data link and network risk were assessed based on various ESF-CCS design specifications. • The effect of fault-tolerant algorithm reliability of safety data network on ESFAS unavailability was assessed. - Abstract: As one of the safety-critical systems in nuclear power plants (NPPs), the Engineered Safety Feature-Component Control System (ESF-CCS) employs safety data link and network communication for the transmission of safety component actuation signals from the group controllers to loop controllers to effectively accommodate various safety-critical field controllers. Since data communication failure risk in the ESF-CCS has yet to be fully quantified, the ESF-CCS employing data communication systems have not been applied in NPPs. This study therefore developed a fault tree model to assess the data link and data network failure-induced unavailability of a system function used to generate an automated control signal for accident mitigation equipment. The current aim is to provide risk information regarding data communication failure in a digital safety feature control system in consideration of interconnection between controllers and the fault-tolerant algorithm implemented in the target system. Based on the developed fault tree model, case studies were performed to quantitatively assess the unavailability of ESF-CCS signal generation due to data link and network failure and its risk effect on safety signal generation failure. This study is expected to provide insight into the risk assessment of safety-critical data communication in a digitalized NPP instrumentation and control system.
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FDA regulation of tobacco: blessing or curse for FDA professionals?
O'Reilly, James T
2009-01-01
Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.
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FDA Acronyms and Abbreviations
U.S. Department of Health & Human Services — The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities
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2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...
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Mining FDA drug labels for medical conditions.
Li, Qi; Deleger, Louise; Lingren, Todd; Zhai, Haijun; Kaiser, Megan; Stoutenborough, Laura; Jegga, Anil G; Cohen, Kevin Bretonnel; Solti, Imre
2013-04-24
Cincinnati Children's Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration's (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system.
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Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.
McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D
2017-01-01
Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.
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75 FR 57279 - Risk Communication Advisory Committee; Notice of Meeting
2010-09-20
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Committee will hear and discuss developments in FDA's ongoing communications programs, such as FDA's...
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Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?
Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.
2015-01-01
Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691
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Communication on the Safety Case for a Deep Geological Repository
International Nuclear Information System (INIS)
Bailey, Lucy; Bernier, Frederik; Bollingerfehr, Wilhelm; Cunado, Miguel; Ilett, Doug; Kwong, Gloria; ); Noseck, Ulrich; Roehlig, Klaus; Van Luik, Abe; Weber, Jan; Weetjens, Eef
2017-01-01
Communication has a specific role to play in the development of deep geological repositories. Building trust with the stakeholders involved in this process, particularly within the local community, is key for effective communication between the authorities and the public. There are also clear benefits to having technical experts hone their communication skills and having communication experts integrated into the development process. This report has compiled lessons from both failures and successes in communicating technical information to non-technical audiences. It addresses two key questions in particular: what is the experience base concerning the effectiveness or non-effectiveness of different tools for communicating safety case results to a non-technical audience and how can communication based on this experience be improved and included into a safety case development effort from the beginning? (authors)
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76 FR 67461 - Cosmetic Microbiological Safety Issues; Public Meeting
2011-11-01
...] Cosmetic Microbiological Safety Issues; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA) is announcing a public meeting entitled ``Cosmetic Microbiological Safety Issues.'' The... cosmetic microbiological safety and to suggest areas for the possible development of FDA guidance documents...
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FDA Warns About Stem Cell Therapies
... Home For Consumers Consumer Updates FDA Warns About Stem Cell Therapies Share Tweet Linkedin Pin it More sharing ... see the boxed section below for more advice. Stem Cell Uses and FDA Regulation The FDA has the ...
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Tippett, Elizabeth C; Chen, Brian K
2015-12-01
Attorneys sponsor television advertisements that include repeated warnings about adverse drug events to solicit consumers for lawsuits against drug manufacturers. The relationship between such advertising, safety actions by the US Food and Drug Administration (FDA), and healthcare use is unknown. To investigate the relationship between attorney advertising, FDA actions, and prescription drug claims. The study examined total users per month and prescription rates for seven drugs with substantial attorney advertising volume and FDA or other safety interventions during 2009. Segmented regression analysis was used to detect pre-intervention trends, post-intervention level changes, and changes in post-intervention trends relative to the pre-intervention trends in the use of these seven drugs, using advertising volume, media hits, and the number of Medicare enrollees as covariates. Data for these variables were obtained from the Center for Medicare and Medicaid Services, Kantar Media, and LexisNexis. Several types of safety actions were associated with reductions in drug users and/or prescription rates, particularly for fentanyl, varenicline, and paroxetine. In most cases, attorney advertising volume rose in conjunction with major safety actions. Attorney advertising volume was positively correlated with prescription rates in five of seven drugs, likely because advertising volume began rising before safety actions, when prescription rates were still increasing. On the other hand, attorney advertising had mixed associations with the number of users per month. Regulatory and safety actions likely reduced the number of users and/or prescription rates for some drugs. Attorneys may have strategically chosen to begin advertising adverse drug events prior to major safety actions, but we found little evidence that attorney advertising reduced drug use. Further research is needed to better understand how consumers and physicians respond to attorney advertising.
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Communication on radiation safety: ability and sensibility
International Nuclear Information System (INIS)
Rozental, Jose de Julio; Ministry of Environment
2001-01-01
Nuclear Communication Issues today, combine aspects of nuclear science, public approach and psychological subjects. The principal objectives are to systematize nuclear public information and to prepare researchers or communicators in a position to comment on the nuclear issues of our stage. The programme should focused on progress of nuclear energy, public perception of risk, conflicts among scientists, as the radiation effect at low doses, and how nuclear industry and scientists may better communicate information concerning the potential for hazard to property, health and the environment. There will be occasions where the competent authority should have formal link with other organizations, as in case of abnormal situation or emergency. Particular attention should be paid to the exchange of distinct parts in order to avoid misinterpretation or mistakes when divulging information to the public.Communication is emphasized in the IAEA Basic Safety Standards, [1] as well as, the current approach created to enlarge the relationship between man, practices and protection by the encouragement of a better understanding and implementation of the Safety Culture concept. The application of this concept involves better protection on Radiation Safety to workers, public and environment not only reducing accidents, but also avoiding unnecessary stresses and strains due to intensified operations. This means an advance towards the humanization of practices, equally observed by industrialized and developing countries. Finally, this paper also comment about two very important lessons that there were not yet learned as in reality necessary, considering the goals for a competent Nuclear Communication: the psychological effects of Chernobyl accident in April 1986 resulted from the lack of public information; the psychological effects of the Radiological Accident in Goiania resulted from the misunderstanding of the basic concept of ionizing radiation, which was translated into fear and
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2011-02-24
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal... Cybersecurity and Communications Reliability Public Safety and Homeland Security Bureau, Federal Communications...
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2013-03-21
... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...
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47 CFR 80.305 - Watch requirements of the Communications Act and the Safety Convention.
2010-10-01
... and the Safety Convention. 80.305 Section 80.305 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Ship Station Safety Watches § 80.305 Watch requirements of the Communications Act and the Safety...
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A theoretical perspective on road safety communication campaigns.
Elvik, Rune
2016-12-01
This paper proposes a theoretical perspective on road safety communication campaigns, which may help in identifying the conditions under which such campaigns can be effective. The paper proposes that, from a theoretical point of view, it is reasonable to assume that road user behaviour is, by and large, subjectively rational. This means that road users are assumed to behave the way they think is best. If this assumption is accepted, the best theoretical prediction is that road safety campaigns consisting of persuasive messages only will have no effect on road user behaviour and accordingly no effect on accidents. This theoretical prediction is not supported by meta-analyses of studies that have evaluated the effects of road safety communication campaigns. These analyses conclude that, on the average, such campaigns are associated with an accident reduction. The paper discusses whether this finding can be explained theoretically. The discussion relies on the distinction made by many modern theorists between bounded and perfect rationality. Road user behaviour is characterised by bounded rationality. Hence, if road users can gain insight into the bounds of their rationality, so that they see advantages to themselves of changing behaviour, they are likely to do so. It is, however, largely unknown whether such a mechanism explains why some road safety communication campaigns have been found to be more effective than others. Copyright © 2015 Elsevier Ltd. All rights reserved.
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FDA Peanut-Containing Product Recall
U.S. Department of Health & Human Services — The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...
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Kennedy, David J; Levin, Joshua; Rosenquist, Richard; Singh, Virtaj; Smith, Clark; Stojanovic, Milan P; Vorobeychik, Yakov
2015-05-01
In April 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication requesting that corticosteroid labeling include warnings that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The International Spine Intervention Society spearheaded a collaboration of more than a dozen other medical societies in submitting the letter below to the FDA on November 7, 2014. We are publishing the letter to ensure that the readership of Pain Medicine is aware of the multisociety support for the safety and effectiveness of these procedures. A special note of thanks to all of the societies who signed on in support of the message. Wiley Periodicals, Inc.
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2013-06-19
... inspections, and drive safety and quality throughout the supply chain. Implementation of these authorities... authorities granted to FDA under Title VII and their importance in ensuring drug safety, effectiveness, and.... FDA-2013-N-0683, FDA-2013-N-0684, and FDA-2013-N-0685] Food and Drug Administration Safety and...
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The challenge of effectively communicating patient safety information.
Hugman, Bruce; Edwards, I Ralph
2006-07-01
Rational use of drugs and patient safety are seriously compromised by a lack of good information, education and effective communication at all stages of drug development and use. From animal trials through to dispensing, there are misconceptions and opportunities for error which current methods of drug information communication do not adequately address: they do not provide those responsible for prescribing and dispensing drugs with the data and information they need to pass on complex and often changing messages to patients and the public. The incidence of adverse reactions due to the way drugs are used; the variable impact of regulatory guidelines and warnings on prescribing behaviour; drug scares and crises suggest a great gap between the ideals of the safe use of medicines and the reality in homes, clinics and hospitals around the world. To address these challenges, the authors review the several levels at which safety information is generated and communicated, and examine how, at each stage, the content and its significance, and the method of communication can be improved.
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Research on communication system of underground safety management based on leaky feeder cable
Institute of Scientific and Technical Information of China (English)
CHEN Jian-hong; ZHANG Tao; CHENG Yun-cai; ZHANG Han
2007-01-01
According to the current working status of underground safety management and production scheduling, the importance and existed problem of underground mine radio communication were summarized, and the basic principle and classification of leaky feeder cable were introduced and the characteristics of cable were analyzed specifically in depth, and the application model of radio communication system for underground mine safety management was put forward. Meanwhile, the research explanation of the system component, function and evaluation was provided. The discussion result indicates that communication system of underground mine safety management which is integrated two-way relay amplifier and other equipment has many communication functions, and underground mine mobile communication can be achieved well.
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FDA Food Code recommendations: how do popular US baking shows measure up?
Directory of Open Access Journals (Sweden)
Valerie Cadorett
2018-05-01
Full Text Available The purpose of this study was to determine if popular US baking shows follow the FDA Food Code recommendations and critical food safety principles. This cross-sectional study examined a convenience sample of 75 episodes from three popular baking shows. The three shows were about competitively baking cupcakes, competitively baking cakes, and baking in a popular local bakery. Twenty-five episodes from each show were viewed. Coding involved tallying how many times 17 FDA Food Code recommendations were or were not followed. On each show, bare hands frequently came in contact with ready-to-eat food. On a per-hour basis, this occurred 80, 155, and 176 times on shows 1-3, respectively. Hands were washed before cooking three times on the three shows and never for the recommended 20 seconds. On each show, many people touched food while wearing jewelry other than a plain wedding band, for an average of at least 7 people per hour on each show. Shows 1-3 had high rates of long-haired bakers not wearing hair restraints (11.14, 6.57, and 14.06 per hour, respectively. Shows 1 and 2 had high rates of running among the bakers (22.29 and 10.57 instances per hour, respectively. These popular baking shows do not demonstrate proper food safety techniques put forth by the FDA and do not contribute the reduction of foodborne illnesses through proper food handling.
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The communication in safety matter
International Nuclear Information System (INIS)
Lacoste, A.C.
1997-01-01
The nuclear risk has three interesting characteristics: it is new, it is insidious and it can be disastrous. These three characteristics lead to consider a particular role of public authorities( Dsin Direction of Nuclear Installations Safety). Nuclear energy can be taxed of two original sins: the close relation between military nuclear and civil nuclear energy, and the nuclear, in France, lacks of democracy.Third point: only five speakers in front of authorities: EDF, Cea, Cogema, Framatome and Andra and these five ones are linked with State. These points summarize the French situation in nuclear energy. By communication the Dsin tries to answer to two obligation, a moral code and a democratic debate. The tools to communicate are the review 'controle' which is published every two months, the Minitel service 'Magnuc ' (code 3614 MAGNUC). This role of communication is not required especially by local elected people but it is the administration which tries to make it work. (N.C.)
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2012-02-28
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal..., Associate Bureau Chief, Public Safety and Homeland Security Bureau, Federal Communications Commission, 445...
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Mining FDA drug labels using an unsupervised learning technique--topic modeling.
Bisgin, Halil; Liu, Zhichao; Fang, Hong; Xu, Xiaowei; Tong, Weida
2011-10-18
The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering "topics" that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that might arise from specific
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Mining FDA drug labels using an unsupervised learning technique - topic modeling
2011-01-01
Background The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. Method In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering “topics” that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. Results The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that
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Pelletier, David L
2005-05-01
The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.
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2010-03-04
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council; Notice of Public Meeting... Analysis Division, Public Safety and Homeland Security Bureau, Federal Communications Commission, 445 12th...
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ISSUES AND RECENT TRENDS IN VEHICLE SAFETY COMMUNICATION SYSTEMS
Directory of Open Access Journals (Sweden)
Sadayuki TSUGAWA
2005-01-01
Full Text Available This paper surveys the research on the applications of inter-vehicle communications, the issues of the deployment and technology, and the current status of inter-vehicle communications projects in Europe, the United States and Japan. The inter-vehicle communications, defined here as communications between on-board ITS computers, improve road traffic safety and efficiency by expanding the horizon of the drivers and on-board sensors. One of the earliest studies on inter-vehicle communications began in Japan in the early 1980s. The inter-vehicle communications play an essential role in automated platooning and cooperative driving systems developed since the 1990's by enabling vehicles to obtain data that would be difficult or impossible to measure with on-board sensors. During these years, interest in applications for inter-vehicle communications increased in the EU, the US and Japan, resulting in many national vehicle safety communications projects such as CarTALK2000 in the EU and VSCC in the US. The technological issues include protocol and communications media. Experiments employ various kinds of protocols and typically use infrared, microwave or millimeter wave media. The situation is ready for standardization. The deployment strategy is another issue. To be feasible, deployment should begin with multiple rather than single services that would work even at a low penetration rate of the communication equipment. In addition, non-technological, legal and institutional issues remained unsolved. Although inter-vehicle communications involve many issues, such applications should be promoted because they will lead to safer and more efficient automobile traffic.
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Leonard, Elizabeth Weeks
2009-01-01
On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.
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Use of a Surgical Safety Checklist to Improve Team Communication.
Cabral, Richard A; Eggenberger, Terry; Keller, Kathryn; Gallison, Barry S; Newman, David
2016-09-01
To improve surgical team communication, a team at Broward Health Imperial Point Hospital, Ft Lauderdale, Florida, implemented a program for process improvement using a locally adapted World Health Organization Surgical Safety Checklist. This program included a standardized, comprehensive time out and a briefing/debriefing process. Postimplementation responses to the Safety Attitudes Questionnaire revealed a significant increase in the surgical team's perception of communication compared with that reported on the pretest (6% improvement resulting in t79 = -1.72, P improved surgical teamwork behaviors and an enhanced culture of safety in the OR. Copyright © 2016 AORN, Inc. Published by Elsevier Inc. All rights reserved.
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Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S
2011-01-01
adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.
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Directory of Open Access Journals (Sweden)
Deborah Korenstein
advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.
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Hemsley, Bronwyn; Georgiou, Andrew; Hill, Sophie; Rollo, Megan; Steel, Joanne; Balandin, Susan
2016-04-01
To review the research literature on the experiences of patients with communication disabilities in hospital according to the Generic Model of patient safety. In 2014 and 2015, we searched four scientific databases for studies with an aim or result relevant to safety of hospital patients with communication disabilities. The review included 27 studies. A range of adverse event types were outlined in qualitative research. Little detail was provided about contributing or protective factors for safety incidents in hospital for these patients or the impact of the incidents on the patient or organisations involved. Further research addressing the safety of patients with communication disabilities is needed. Sufficient detail is required to identify the nature, timing, and detection of incidents; factors that contribute to or prevent adverse events; and detail the impact of the adverse events. In order to provide safe and effective care to people with communication disabilities in hospital, a priority for health and disability services must be the design and evaluation of ecologically appropriate and evidence-based interventions to improve patient care, communication, and reduce the risk of costly and harmful patient safety incidents. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
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Research on crisis communication of nuclear and radiation safety
International Nuclear Information System (INIS)
Cao Yali; Zhang Ying
2013-01-01
Insufficient public cognition of nuclear and radiation safety and absence of effective method to handle crisis lead to common crisis events of nuclear and radiation safety, which brings about unfavorable impact on the sound development of nuclear energy exploring and application of nuclear technology. This paper, based on crisis communication theory, analyzed the effect of current situation on nuclear and radiation safety crisis, discussed how to handle crisis, and tried to explore the effective strategies for nuclear and radiation safety crisis handling. (authors)
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The communicative construction of safety in wildland firefighting (Proceedings)
Jody Jahn
2012-01-01
This dissertation project used a two-study mixed methods approach, examining the communicative accomplishment of safety from two perspectives: high reliability organizing (Weick, Sutcliffe, & Obstfeld 1999), and safety climate (Zohar 1980). In Study One, 27 firefighters from two functionally similar wildland firefighting crews were interviewed about their crew-...
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Communication and Consultation with Interested Parties by the Regulatory Body. General Safety Guide
International Nuclear Information System (INIS)
2017-01-01
This Safety Guide provides recommendations on meeting the safety requirements concerning communication and consultation with the public and other interested parties by the regulatory body about the possible radiation risks associated with facilities and activities, and about processes and decisions of the regulatory body. The Safety Guide can be used by authorized parties in circumstances where there are regulatory requirements placed on them for communication and consultation. It may also be used by other organizations or individuals considering their responsibilities for communication and consultation with interested parties.
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Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.
Deyo, Richard A
2004-01-01
Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.
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Culture, communication and safety: lessons from the airline industry.
d'Agincourt-Canning, Lori G; Kissoon, Niranjan; Singal, Mona; Pitfield, Alexander F
2011-06-01
Communication is a critical component of effective teamwork and both are essential elements in providing high quality of care to patients. Yet, communication is not an innate skill but a process influenced by internal (personal/cultural values) as well as external (professional roles and hierarchies) factors. To provide illustrative cases, themes and tools for improving communication. Literature review and consensus opinion based on extensive experience. Professional autonomy should be de-emphasized. Tools such as SBAR and simulation are important in communication and teamwork. Tools designed to improve communication and safety in the aviation industry may have applicability to the pediatric intensive care unit.
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An architecture model for communication of safety in public transportation
Rajabalinejad, Mohammad; Horváth, Imre; Pernot, Jean-Paul; Rusák, Zoltan
2016-01-01
Safety in transportation is under the influence of the rising complexity, increasing demands for capacity and decreasing cost. Furthermore, the interdisciplinary environment of operation and altered safety regulations invite for a centralized (integrated) modelling/ communication approach. This
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Lin, Ching-Fu
The United States has a high stake in China’s serious food safety problem, as food products of Chinese origin have dominated the U.S. food market in numerous areas and continue to grow. The conclusion of the U.S.-China Food Safety Agreement (“the Agreement”) has allowed FDA to strengthen regulatory cooperation with its Chinese counterpart in various aspects. The Agreement also paves the way for the implementation of the new regulatory tools incorporated in FSMA, especially in the cross-border context. However, both the Agreement and FSMA have certain crucial limitations that may create future hurdles to effective implementation in the U.S.-China cooperation. This paper therefore endeavors to first examine China’s governance challenges over food safety, with a focus on the 2009 Food Safety Law, the 2015 Amendment, and the fundamental problem of “thin” rule of law. This paper moves to analyze the U.S.-China Food Safety Agreement, reviewing the agreement’s strengths and weaknesses. It further assesses FSMA’s innovative institutional design to regulate imported food products and its limitations. However, both the U.S.-China Food Safety Agreement and FSMA arguably create a regulatory dilemma for FDA when addressing imported food safety, due to structural mismatch between the broad scope of power granted to FDA and the long chain of power outsourcing to governments or private companies as primary “regulators.” Neither the Agreement nor FSMA give FDA adequate capacity to closely oversee such “agents” along the chain of power outsourcing. Framing the U.S.-China food safety cooperation as a multilayer structure that “outsources power” to “import safety,” this paper concludes by stressing the need for a robust accountability and effective mechanism for U.S.-China food safety cooperation.
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Public Safety Communications: Policy, Proposals, Legislation and Progress
National Research Council Canada - National Science Library
Moore, Linda K
2005-01-01
Since September 11, 2001, the effectiveness of America's communications capabilities in support of the information needs of first responders and other public safety workers has been a matter of concern to Congress...
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Silla, Inmaculada; Navajas, Joaquin; Koves, G Kenneth
2017-06-01
A safety-conscious work environment allows high-reliability organizations to be proactive regarding safety and enables employees to feel free to report any concern without fear of retaliation. Currently, research on the antecedents to safety-conscious work environments is scarce. Structural equation modeling was applied to test the mediating role of employee communication satisfaction in the relationship between constructive culture and a safety-conscious work environment in several nuclear power plants. Employee communication satisfaction partially mediated the positive relationships between a constructive culture and a safety-conscious work environment. Constructive cultures in which cooperation, supportive relationships, individual growth and high performance are encouraged facilitate the establishment of a safety-conscious work environment. This influence is partially explained by increased employee communication satisfaction. Constructive cultures should be encouraged within organizations. In addition, managers should promote communication policies and practices that support a safety-conscious work environment. Copyright © 2017 Elsevier Ltd and National Safety Council. All rights reserved.
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Zelkin, Natalie; Henriksen, Stephen
2011-01-01
This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed C-band (5091- to 5150-MHz) airport surface communication system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents an initial high-level safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the C-band communication system after the profile is finalized and system rollout timing is determined. A security risk assessment has been performed by NASA as a parallel activity. While safety analysis is concerned with a prevention of accidental errors and failures, the security threat analysis focuses on deliberate attacks. Both processes identify the events that affect operation of the system; and from a safety perspective the security threats may present safety risks.
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Verification of the safety communication protocol in train control system using colored Petri net
International Nuclear Information System (INIS)
Chen Lijie; Tang Tao; Zhao Xianqiong; Schnieder, Eckehard
2012-01-01
This paper deals with formal and simulation-based verification of the safety communication protocol in ETCS (European Train Control System). The safety communication protocol controls the establishment of safety connection between train and trackside. Because of its graphical user interface and modeling flexibility upon the changes in the system conditions, this paper proposes a composition Colored Petri Net (CPN) representation for both the logic and the timed model. The logic of the protocol is proved to be safe by means of state space analysis: the dead markings are correct; there are no dead transitions; being fair. Further analysis results have been obtained using formal and simulation-based verification approach. The timed models for the open transmit system and the application process are created for the purpose of performance analysis of the safety communication protocol. The models describe the procedure of data transmission and processing, and also provide relevant timed and stochastic factors, as well as time delay and lost packet, which may influence the time for establishment of safety connection of the protocol. Time for establishment of safety connection of the protocol in normal state is verified by formal verification, and then time for establishment of safety connection with different probability of lost packet is simulated. After verification it is found that the time for establishment of safety connection of the safety communication protocol satisfies the safety requirements.
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Guttman, Nurit
2015-11-01
Communication campaigns are employed as an important tool to promote road safety practices. Researchers maintain road safety communication campaigns are more effective when their persuasive appeals, which are central to their communicative strategy, are based on explicit theoretical frameworks. This study's main objectives were to develop a detailed categorization of persuasive appeals used in road safety communication campaigns that differentiate between appeals that appear to be similar but differ conceptually, and to indicate the advantages, limitations and ethical issues associated with each type, drawing on behavior change theories. Materials from over 300 campaigns were obtained from 41 countries, mainly using road safety organizations' websites. Drawing on the literature, five types of main approaches were identified, and the analysis yielded a more detailed categorizations of appeals within these general categories. The analysis points to advantages, limitations, ethical issues and challenges in using different types of appeals. The discussion summarizes challenges in designing persuasive-appeals for road safety communication campaigns. Copyright © 2015 Elsevier Ltd. All rights reserved.
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2011-08-31
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal.... Postal Service Mail to Jeffery Goldthorp, Associate Bureau Chief, Public Safety and Homeland Security...
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Awareness and trust of the FDA and CDC: Results from a national sample of US adults and adolescents.
Directory of Open Access Journals (Sweden)
Sarah D Kowitt
Full Text Available Trust in government agencies plays a key role in advancing these organizations' agendas, influencing behaviors, and effectively implementing policies. However, few studies have examined the extent to which individuals are aware of and trust the leading United States agencies devoted to protecting the public's health. Using two national samples of adolescents (N = 1,125 and adults (N = 5,014, we examined demographic factors, with a focus on vulnerable groups, as correlates of awareness of and trust in the Centers for Disease Control and Prevention (CDC, Food and Drug Administration (FDA, and the federal government. From nine different weighted and adjusted logistic regression models, we found high levels of awareness of the existence of the FDA and CDC (ranging from 55.7% for adolescents' awareness of the CDC to 94.3% for adults' awareness of the FDA and moderate levels of trust (ranging from a low of 41.8% for adults' trust in the federal government and a high of 78.8% for adolescents' trust of the FDA. In the adolescent and adult samples, awareness was higher among non-Hispanic Blacks and respondents with low numeracy. With respect to trust, few consistent demographic differences emerged. Our findings provide novel insights regarding awareness and trust in the federal government and specific United States public health agencies. Our findings suggest groups to whom these agencies may want to selectively communicate to enhance trust and thus facilitate their communication and regulatory agendas.
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75 FR 67807 - Pipeline Safety: Emergency Preparedness Communications
2010-11-03
... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... is issuing an Advisory Bulletin to remind operators of gas and hazardous liquid pipeline facilities... Gas Pipeline Systems. Subject: Emergency Preparedness Communications. Advisory: To further enhance the...
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Safety on a Rural Community College Campus via Integrated Communications
Gnage, Marie Foster; Dziagwa, Connie; White, Dave
2009-01-01
West Virginia University at Parkersburg uses a two-way emergency system as a baseline for emergency communications. The college has found that such a system, a key component of its safety and crisis management plan, can be integrated with other communication initiatives to provide focused security on the campus.
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One and done: Reasons principal investigators conduct only one FDA-regulated drug trial
Directory of Open Access Journals (Sweden)
Amy Corneli, PhD, MPH
2017-06-01
Full Text Available Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as “one-and-done.” Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1 workload balance (balancing trial implementation with other work obligations and opportunities (63.8%; 2 time requirements (time to initiate and implement trial; investigator and staff time (63.4%; and 3 data and safety reporting (56.5%. Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly “one-and-done.” Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.
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Quantitative Safety and Security Analysis from a Communication Perspective
DEFF Research Database (Denmark)
Malinowsky, Boris; Schwefel, Hans-Peter; Jung, Oliver
2014-01-01
This paper introduces and exemplifies a trade-off analysis of safety and security properties in distributed systems. The aim is to support analysis for real-time communication and authentication building blocks in a wireless communication scenario. By embedding an authentication scheme into a real...... at handover situations in a IEEE 802.11 wireless setup between mobile nodes and access points. The trade-offs involve application-layer data goodput, probability of completed handovers, and effect on usable protocol slots, to quantify the impact of security from a lower-layer communication perspective...
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Data rate based congestion control in V2V communication for traffic safety applications
Belagal Math, C.; Özgür, A.; Heemstra de Groot, S.M.; Li, H.
2015-01-01
Vehicle-to-Vehicle (V2V) communication systems intend to increase safety and efficiency of the transportation networks. At high vehicle density, the communication channel may become congested, impairing the reliability of the safety applications. As a counter measure, the European Telecommunications
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A Systematic Review of the Use of Social Media for Food Safety Risk Communication.
Overbey, Katie N; Jaykus, Lee-Ann; Chapman, Benjamin J
2017-09-01
This article covers the current published literature related to the use of social media in food safety and infectious disease communication. The aim was to analyze literature recommendations and draw conclusions about how best to utilize social media for food safety risk communication going forward. A systematic literature review was conducted, and 24 articles were included for analysis. The inclusion criteria were (i) original peer-reviewed articles and (ii) primary focus on communication through social media about food safety and/or infectious diseases. Studies were coded for themes about social media applications, benefits, limitations, and best practices. Trust and personal beliefs were important drivers of social media use. The wide reach, immediacy, and information gathering capacities of social media were frequently cited benefits. Suggestions for social media best practices were inconsistent among studies, and study designs were highly variable. More evidence-based suggestions are needed to better establish guidelines for social media use in food safety and infectious disease risk communication. The information gleaned from this review can be used to create effective messages for shaping food safety behaviors.
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International Nuclear Information System (INIS)
Cao Yali; Wang Erqi; Wang Xiaofeng; Zhang Ying
2014-01-01
The studies of the application of science communication theory in the nuclear and radiation safety will help to enhance the level of science popularization work in the field of nuclear and radiation safety. This paper firstly describes the definition and the evolvement process of science communication models, then analyzes the current status of the nuclear and radiation safety science popularization, finally discusses on the suitability of science communication mode of its application in the field of nuclear and radiation safety. (authors)
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21 CFR 60.34 - FDA action on petitions.
2010-04-01
... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... this section or investigate and determine under § 60.36 whether the applicant acted with due diligence during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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Safety considerations for patients with communication disorders in rehabilitation medicine settings.
Cristian, Adrian; Giammarino, Claudia; Olds, Michael; Adams, Elizabeth; Moriarty, Christina; Ratner, Sabina; Mural, Shruti; Stobart, Eric C
2012-05-01
Communication barriers can pose a significant safety risk for patients. Individuals in a communication-vulnerable state are commonly seen in rehabilitation settings. These patients cannot adequately communicate their symptoms, wants, and needs to providers. Causes of communication barriers include neurologic impairments, such as stroke, cerebral palsy, and Parkinson disease, and language barriers. The ability of clinicians to adequately diagnose, treat, and monitor these patients is also hindered. This article identifies key communication barriers and strategies that clinicians can use to effectively communicate with these patients. Copyright © 2012 Elsevier Inc. All rights reserved.
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No sisyphean task: how the FDA can regulate electronic cigarettes.
Paradise, Jordan
2013-01-01
The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009
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Jain, Anshu K; Fennell, Mary L; Chagpar, Anees B; Connolly, Hannah K; Nembhard, Ingrid M
2016-11-01
Effective communication is a requirement in the teamwork necessary for improved coordination to deliver patient-centered, value-based cancer care. Communication is particularly important when care providers are geographically distributed or work across organizations. We review organizational and teams research on communication to highlight psychological safety as a key determinant of high-quality communication within teams. We first present the concept of psychological safety, findings about its communication effects for teamwork, and factors that affect it. We focus on five factors applicable to cancer care delivery: familiarity, clinical hierarchy-related status differences, geographic dispersion, boundary spanning, and leader behavior. To illustrate how these factors facilitate or hinder psychologically safe communication and teamwork in cancer care, we review the case of a patient as she experiences the treatment-planning process for early-stage breast cancer in a community setting. Our analysis is summarized in a key principle: Teamwork in cancer care requires high-quality communication, which depends on psychological safety for all team members, clinicians and patients alike. We conclude with a discussion of the implications of psychological safety in clinical care and suggestions for future research.
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Software coding for reliable data communication in a reactor safety system
International Nuclear Information System (INIS)
Maghsoodi, R.
1978-01-01
A software coding method is proposed to improve the communication reliability of a microprocessor based fast-reactor safety system. This method which replaces the conventional coding circuitry, applies a program to code the data which is communicated between the processors via their data memories. The system requirements are studied and the suitable codes are suggested. The problems associated with hardware coders, and the advantages of software coding methods are discussed. The product code which proves a faster coding time over the cyclic code is chosen as the final code. Then the improvement of the communication reliability is derived for a processor and its data memory. The result is used to calculate the reliability improvement of the processing channel as the basic unit for the safety system. (author)
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Development of a safety communication and recognition program for construction.
Sparer, Emily H; Herrick, Robert F; Dennerlein, Jack T
2015-05-01
Leading-indicator-based (e.g., hazard recognition) incentive programs provide an alternative to controversial lagging-indicator-based (e.g., injury rates) programs. We designed a leading-indicator-based safety communication and recognition program that incentivized safe working conditions. The program was piloted for two months on a commercial construction worksite and then redesigned using qualitative interview and focus group data from management and workers. We then ran the redesigned program for six months on the same worksite. Foremen received detailed weekly feedback from safety inspections, and posters displayed worksite and subcontractor safety scores. In the final program design, the whole site, not individual subcontractors, was the unit of analysis and recognition. This received high levels of acceptance from workers, who noted increased levels of site unity and team-building. This pilot program showed that construction workers value solidarity with others on site, demonstrating the importance of health and safety programs that engage all workers through a reliable and consistent communication infrastructure. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
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Agency perspectives on food safety for the products of animal biotechnology.
Howard, H J; Jones, K M; Rudenko, L
2012-08-01
Animal biotechnology represents one subset of tools among a larger set of technologies for potential use to meet increasing world demands for food. Assisted reproductive technologies (ART) such as artificial insemination and embryo transfer continue to make positive contributions in food animal production. The US Food and Drug Administration (FDA) performed a comprehensive risk assessment to identify potential food consumption or animal health risks associated with animal cloning, an emerging ART. At that time, FDA concluded that animal cloning posed no unique risks either to animal health or to food consumption, and food from animal clones and their sexually reproduced offspring required no additional federal regulation beyond that applicable to conventionally bred animals of the species examined. At this time, no new information has arisen that would necessitate a change in FDA's conclusions on food from animal clones or their sexually reproduced offspring. Use of recombinant DNA technologies to produce genetically engineered (GE) animals represents another emerging technology with potential to impact food animal production. In its regulation of GE animals, FDA follows a cumulative, risk-based approach to address scientific questions related to the GE animals. FDA evaluates data and information on the safety, effectiveness and stability of the GE event. FDA carries out its review at several levels (e.g. molecular biology, animal safety, food safety, environmental safety and claim validation). GE animal sponsors provide data to address risk questions for each level. This manuscript discusses FDA's role in evaluation of animal cloning and GE animals. © 2012 Blackwell Verlag GmbH.
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2011-07-14
...., Bldg. 51, rm. 2201, Silver Spring, MD 20993- 0002, or Office of Communication, Outreach and Development... help make critical treatment decisions. FDA oversight of companion diagnostics will protect patients... current thinking on companion diagnostic devices. It does not create or confer any rights for or on any...
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Nuclear risk and communication: the essential role of safety authorities
International Nuclear Information System (INIS)
Hautin, N.
1998-01-01
Full text of publication follows: whether concerning mad cow disease, asbestos, nuclear, OGM or now, dioxin in French meat, public health risks have been making the headlines of newspapers for a while. And, firms whose activity is associated with these risks are in effect in the defendants box. Therefore, communicating becomes difficult: their word is suspect and, debates quite rapidly exceed the firm competencies to become a socio-cultural conflict. This paper explores in nuclear fields the essential role of safety authorities in such communication cases. Our surveys and the comparative case study between the pipe at La Hague and 'contaminated' nuclear transports in France are eloquent: the messages of nuclear firms is perceived through their image of a State within the State built from the past and reinforced by the negative prism of the news. Regular and technical arguments (the respect of norms) entertain the debate rather than hush it. That is why we could infer an objective, and independent opinion is required, one different from the firm, the public and ministries: its role of referee could allow a constructive dialog between the public and the firm. Risk communication nature and efficiency depend on that (cf. the diagram). As a solution, we think about a legitimate authority organization identified by the public first, but by other actors as well. From the public point of view, if we see the place of pressure groups (e.g. Greenpeace) in the debate as a measure of the lack of trust in the independence of safety authorities, we can infer that it is a reaffirmation of democracy which is demanded by the French public, which could be satisfied with powerful safety authorities. That is why safety authorities have an essential role to play, beyond this of control, in nuclear risk communication towards the public. Diagram: communication path between a nuclear firm and the public during conflict. (author)
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Zelkin, Natalie; Henriksen, Stephen
2011-01-01
This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract NNC05CA85C, Task 7: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed L-band (960 to 1164 MHz) terrestrial en route communications system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents a preliminary safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the L-band communication system after the technology is chosen and system rollout timing is determined. The security risk analysis resulted in identifying main security threats to the proposed system as well as noting additional threats recommended for a future security analysis conducted at a later stage in the system development process. The document discusses various security controls, including those suggested in the COCR Version 2.0.
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Risk Communication: A Key for Fostering a More Resilient Safety Culture
International Nuclear Information System (INIS)
Nishizawa, M.
2016-01-01
It is widely agreed that the accident of the Fukushima Daiichi nuclear power plant was not only triggered by natural events combined with technical failures, but was a human induced disaster. From the bitter lessons, we have learned that human and organizational factors associated with emergency planning, response and decision-making for nuclear safety need to be more carefully reviewed and enhanced. Elements of social sciences, especially, risk management and risk communication here play a key role. Risk communication is an established concept within risk analysis frameworks. It is a vital tool to convey the meaning of scientific assessment and risk management, share safety related information, and exchange views and values amongst varying stakeholder groups. Risk communication aims at building trust through this process and human interactions. However, it would not be an overstatement that the essence of risk communication is not fully understood. As a result, it is either partially integrated into risk management practice or remains unconducive. The marginalisation of risk communication is observed in a variety of risk communication practices, or more evidently, in perception gaps between lays and experts about risks.
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Guttman, Nurit
2016-12-01
Communication campaigns are employed as an important tool to promote road safety practices. Researchers maintain road safety communication campaigns are more effective when their persuasive appeals, which are central to their communicative strategy, are based on explicit theoretical frameworks. This study's main objectives were to develop a detailed categorization of persuasive appeals used in road safety communication campaigns that differentiate between appeals that appear to be similar but differ conceptually, and to indicate the advantages, limitations and ethical issues associated with each type, drawing on behavior change theories. Materials from over 300 campaigns were obtained from 41 countries, mainly using road safety organizations' websites. Drawing on the literature, five types of main approaches were identified, and the analysis yielded a more detailed categorizations of appeals within these general categories. The analysis points to advantages, limitations, ethical issues and challenges in using different types of appeals. The discussion summarizes challenges in designing persuasive-appeals for road safety communication campaigns. Copyright © 2015 Elsevier Ltd. All rights reserved.
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Real-World Evidence, Public Participation, and the FDA.
Schwartz, Jason L
2017-11-01
For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.
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Energy Technology Data Exchange (ETDEWEB)
Son, Kwang Seop; Lee, Jang Soo; Kim, Jung Heon [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)
2009-05-15
The field bus has been developed for a network system which supports the real-time communication of various controls and automation equipment. It is known for Profibus in the field of a production automation environment. The Profibus standard uses open communication based on the ISO/OSI model. The Probibus standard uses layer 1, layer 2, layer 7. Layer 7 of Probibus FMS(Fieldbus Message Specification) provides a information and the user of a station. The high-level communication of the safety-grade PLC (POSAFE-Q) developed through the KNICS(Korea Nuclear I and C System) project is the FMS This paper describes the design, the configuration, and the test method of the FMS communication module.
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International Nuclear Information System (INIS)
Son, Kwang Seop; Lee, Jang Soo; Kim, Jung Heon
2009-01-01
The field bus has been developed for a network system which supports the real-time communication of various controls and automation equipment. It is known for Profibus in the field of a production automation environment. The Profibus standard uses open communication based on the ISO/OSI model. The Probibus standard uses layer 1, layer 2, layer 7. Layer 7 of Probibus FMS(Fieldbus Message Specification) provides a information and the user of a station. The high-level communication of the safety-grade PLC (POSAFE-Q) developed through the KNICS(Korea Nuclear I and C System) project is the FMS This paper describes the design, the configuration, and the test method of the FMS communication module
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Family communication patterns and teen drivers' attitudes toward driving safety.
Yang, Jingzhen; Campo, Shelly; Ramirez, Marizen; Krapfl, Julia Richards; Cheng, Gang; Peek-Asa, Corinne
2013-01-01
Family communication patterns (FCPs) play an important role in reducing the risk-taking behaviors of teens, such as substance use and safer sex. However, little is known about the relationship between family communication and teen driving safety. We analyzed the baseline data from a randomized trial that included 163 parent-teen dyads, with teens who would be receiving their intermediate driver's license within 3 months. FCPs were divided into four types-pluralistic, protective, consensual, and laissez-faire-and were correlated with the frequency of parent-teen discussions and teens' driving safety attitudes. The ratings on four types of FCPs were distributed quite evenly among teens and parents. Parents and teens agreed on their FCP ratings (p = .64). In families with communication patterns that were laissez-faire, protective, and pluralistic, parents talked to their teens less about safe driving than did parents in families with a consensual communication pattern (p < .01). Moreover, the frequency of parent-teen communication about safe driving was positively associated with teen attitudes toward safe driving (adjusted β = 0.35, p = .03). Health care providers need to encourage parents, particularly those with non-consensual FCPs, to increase frequency of parent-teen interactions. Copyright © 2013 National Association of Pediatric Nurse Practitioners. Published by Mosby, Inc. All rights reserved.
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Safety of Bottled Water Beverages Including Flavored Water and Nutrient-Added Water Beverages
... Food Resources for You Consumers FDA Regulates the Safety of Bottled Water Beverages Including Flavored Water and Nutrient-Added Water Beverages ... addition, the flavorings and nutrients added to these beverages must comply with all applicable FDA safety requirements and they must be identified in the ...
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Identifying Food Safety Concerns when Communication Barriers Exist
Neal, Jack A.; Dawson, Mary; Madera, Juan M.
2011-01-01
Abstract: Students must be prepared to lead a diverse workforce. The objective of this study was to establish a teaching method that helps students identify barriers to food safety while working in a simulated environment with communication barriers. This study employed a perspective taking exercise based upon the principles of social learning…
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Folbert, J.P.; Dagevos, J.C.
2001-01-01
De oprichting van een Europese Voedselautoriteit die in 2002 operationeel moet zijn. Velen zien hierin een evenbeeld van de Amerikaanse FDA (Food and Drug Administration). Deze instantie werkt echter niet zo ideaal als vaak wordt voorgesteld. Het belangrijkste verschil tussen beide instanties is de
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2010-11-30
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal...) Communications Security, Reliability, and Interoperability Council (CSRIC) will hold its fourth meeting on...
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2012-10-04
... regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA...-0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This...
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Remote mobile communication in safety support system
International Nuclear Information System (INIS)
Inagaki, Kanji; Kobayashi, Hiroyuki; Hatanaka, Takahiro; Sakuma, Akira; Fukumoto, Akira; Ikeda, Jun
1999-01-01
Safety Support System (SSS) is a computerized operator support system for nuclear power plants, which is now under development. The concept of SSS covers 1) earlier detection of failure symptom and prediction of its influence to the plant operation, 2) improved transparency and robustness of plant control systems, 3) advanced human-machine interface and communication. The authors have been working on the third concept and proposed a remote mobile communication system called Plant Communication System (PCS). PCS aims to realize convenient communication between main control room and other areas such as plant local areas and site offices, using Personal Handyphone System (PHS) and wireless LAN (Local Area Network). PCS can transmit not only data but also graphic displays and dynamic video displays between the main control room and plant local areas. MPEG4 (Moving Picture Experts Group 4) technology is utilized in video data compression and decompression. The authors have developed the special multiplexing unit that connects PHS Cell Stations (CSs) and exiting coaxial cables. Voice recognition and announcement capability is also realized in the system, which enables verbal retrieval of information in the computer systems in the main control room from local areas. (author)
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2010-09-16
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal...) Communications Security, Reliability, and Interoperability Council (CSRIC) will hold its third meeting on October...
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Communication Regulatory Science: Mapping a New Field.
Noar, Seth M; Cappella, Joseph N; Price, Simani
2017-12-13
Communication regulatory science is an emerging field that uses validated techniques, tools, and models to inform regulatory actions that promote optimal communication outcomes and benefit the public. In the opening article to this special issue on communication and tobacco regulatory science, we 1) describe Food and Drug Administration (FDA) regulation of tobacco products in the US; 2) introduce communication regulatory science and provide examples in the tobacco regulatory science realm; and 3) describe the special issue process and final set of articles. Communication research on tobacco regulatory science is a burgeoning area of inquiry, and this work advances communication science, informs and potentially guides the FDA, and may help to withstand legal challenges brought by the tobacco industry. This research has the potential to have a major impact on the tobacco epidemic and population health by helping implement the most effective communications to prevent tobacco initiation and increase cessation. This special issue provides an example of 10 studies that exemplify tobacco regulatory science and demonstrate how the health communication field can affect regulation and benefit public health.
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Building Comprehensive Strategies for Obstetric Safety: Simulation Drills and Communication.
Austin, Naola; Goldhaber-Fiebert, Sara; Daniels, Kay; Arafeh, Julie; Grenon, Veronique; Welle, Dana; Lipman, Steven
2016-11-01
As pioneers in the field of patient safety, anesthesiologists are uniquely suited to help develop and implement safety strategies to minimize preventable harm on the labor and delivery unit. Most existing obstetric safety strategies are not comprehensive, lack input from anesthesiologists, are designed with a relatively narrow focus, or lack implementation details to allow customization for different units. This article attempts to address these gaps and build more comprehensive strategies by discussing the available evidence and multidisciplinary authors' local experience with obstetric simulation drills and optimization of team communication.
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U.S. Department of Health & Human Services — This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number...
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FDA and the Chemical Brain Drainers
DEFF Research Database (Denmark)
Grandjean, Philippe
2017-01-01
Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907......Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907...
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Performance and Reliability of DSRC Vehicular Safety Communication: A Formal Analysis
Directory of Open Access Journals (Sweden)
2009-02-01
Full Text Available IEEE- and ASTM-adopted dedicated short range communications (DSRC standard toward 802.11p is a key enabling technology for the next generation of vehicular safety communication. Broadcasting of safety messages is one of the fundamental services in DSRC. There have been numerous publications addressing design and analysis of such broadcast ad hoc system based on the simulations. For the first time, an analytical model is proposed in this paper to evaluate performance and reliability of IEEE 802.11a-based vehicle-to-vehicle (V2V safety-related broadcast services in DSRC system on highway. The proposed model takes two safety services with different priorities, nonsaturated message arrival, hidden terminal problem, fading transmission channel, transmission range, IEEE 802.11 backoff counter process, and highly mobile vehicles on highway into account. Based on the solutions to the proposed analytic model, closed-form expressions of channel throughput, transmission delay, and packet reception rates are derived. From the obtained numerical results under various offered traffic and network parameters, new insights and enhancement suggestions are given.
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FDA Recognized Consensus Standards
U.S. Department of Health & Human Services — This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information...
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21 CFR 315.6 - Evaluation of safety.
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Evaluation of safety. 315.6 Section 315.6 Food and... USE DIAGNOSTIC RADIOPHARMACEUTICALS § 315.6 Evaluation of safety. (a) Factors considered in the safety...)(1) To establish the safety of a diagnostic radiopharmaceutical, FDA may require, among other...
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Interprofessional education in team communication: working together to improve patient safety.
Brock, Douglas; Abu-Rish, Erin; Chiu, Chia-Ru; Hammer, Dana; Wilson, Sharon; Vorvick, Linda; Blondon, Katherine; Schaad, Douglas; Liner, Debra; Zierler, Brenda
2013-11-01
Communication failures in healthcare teams are associated with medical errors and negative health outcomes. These findings have increased emphasis on training future health professionals to work effectively within teams. The Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) communication training model, widely employed to train healthcare teams, has been less commonly used to train student interprofessional teams. The present study reports the effectiveness of a simulation-based interprofessional TeamSTEPPS training in impacting student attitudes, knowledge and skills around interprofessional communication. Three hundred and six fourth-year medical, third-year nursing, second-year pharmacy and second-year physician assistant students took part in a 4 h training that included a 1 h TeamSTEPPS didactic session and three 1 h team simulation and feedback sessions. Students worked in groups balanced by a professional programme in a self-selected focal area (adult acute, paediatric, obstetrics). Preassessments and postassessments were used for examining attitudes, beliefs and reported opportunities to observe or participate in team communication behaviours. One hundred and forty-nine students (48.7%) completed the preassessments and postassessments. Significant differences were found for attitudes toward team communication (pteam structure (p=0.002), situation monitoring (pteams (pteam communication is important in patient safety. We demonstrate positive attitudinal and knowledge effects in a large-scale interprofessional TeamSTEPPS-based training involving four student professions.
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21 CFR 60.10 - FDA assistance on eligibility.
2010-04-01
... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in... in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852...
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77 FR 31025 - Risk Communication Advisory Committee; Notice of Meeting
2012-05-24
... on communicating and understanding uncertainty, and risk perception and information seeking when facing multiple risks. FDA intends to make background material available to the public no later than 2... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001...
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Do safety checklists improve teamwork and communication in the operating room? A systematic review.
Russ, Stephanie; Rout, Shantanu; Sevdalis, Nick; Moorthy, Krishna; Darzi, Ara; Vincent, Charles
2013-12-01
The aim of this systematic review was to assess the impact of surgical safety checklists on the quality of teamwork and communication in the operating room (OR). Safety checklists have been shown to impact positively on patient morbidity and mortality following surgery, but it is unclear whether this clinical improvement is related to an improvement in OR teamwork and communication. A systematic search strategy of MEDLINE, EMBASE, PsycINFO, Google Scholar, and the Cochrane Database for Systematic Reviews was undertaken to obtain relevant articles. After de-duplication and the addition of limits, 315 articles were screened for inclusion by 2 researchers and all articles meeting a set of prespecified inclusion criteria were retained. Information regarding the type of checklist, study design, assessment tools used, outcomes, and study limitations was extracted. Twenty articles formed the basis of this systematic review. All articles described an empirical study relating to a case-specific safety checklist for surgery as the primary intervention, with some measure of change/improvement in teamwork and/or communication relating to its use. The methods for assessing teamwork and communication varied greatly, including surveys, observations, interviews, and 360° assessments. The evidence suggests that safety checklists improve the perceived quality of OR teamwork and communication and reduce observable errors relating to poor team skills. This is likely to function through establishing an open platform for communication at the start of a procedure: encouraging the sharing of critical case-related information, promoting team coordination and decision making, flagging knowledge gaps, and enhancing team cohesion. However, the evidence would also suggest that when used suboptimally or when individuals have not bought in to the process, checklists may conversely have a negative impact on the function of the team. Safety checklists are beneficial for OR teamwork and
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Havelaar, Arie H; Vazquez, Kathleen M; Topalcengiz, Zeynal; Muñoz-Carpena, Rafael; Danyluk, Michelle D
2017-01-01
The U.S. Food and Drug Administration (FDA) has defined standards for the microbial quality of agricultural surface water used for irrigation. According to the FDA produce safety rule (PSR), a microbial water quality profile requires analysis of a minimum of 20 samples for Escherichia coli over 2 to
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The FDA's decision-making process: isn't it time to temper the principle of protective paternalism?
Brandt, Lawrence J
2008-05-01
The authors conducted a well-designed, multinational, large study of women younger than 65 yr of age with irritable bowel syndrome (IBS) with a mixed pattern of diarrhea and constipation (IBS-M) or constipation (IBS-C) and showed that a statistically greater percentage of patients in each group responded to tegaserod compared with patients treated with placebo. Practicality looms large, however, in that the Food and Drug Administration (FDA) disallowed the continued marketing of tegaserod because of cardiovascular safety concerns, and it now is only available under a restricted access program. The wisdom of this decision aside, it is disturbing that the FDA revealed a zero-tolerance for any significant risk of disease when a drug (e.g., tegaserod) was used for a nonlife-threatening condition; the FDA chose to neglect any potential benefit of significant improvement in quality of life, while at the same time allowing the continued availability of sildenifil for erectile dysfunction and other medications (e.g., rosiglitazone and nonsteroidal anti-inflammatory drugs [NSAIDs]), each with a far greater risk of cardiovascular complications. Whether tegaserod will be re-released and, if so, under what conditions, is yet to be determined, as is the question of whether the FDA will decide to allow a more transparent decision-making process with input from all interested parties affected by their decision.
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Public perception on nuclear safety and communication
International Nuclear Information System (INIS)
Wieland, Patricia
1998-01-01
Nowadays the benefits and advantages of the nuclear application are varied and so many, that it is difficult to imagine the development of medicine, industry and agriculture without using ionizing radiation. The communication of nuclear issues to the public is receiving more and more attention of the regulatory authorities. First, because it is a very interesting topic that the public wishes to learn more. Second, for safety reasons: the public needs to know the benefits and risks of nuclear energy and when and how they should protect themselves from the radiation. In all cases, the communication should be constant and not only during crisis, such as suspicion of or during accidents with radioactive material. The public worries and their questions should be clarified quickly. An information network should be used in order to communicate the benefits and uses of radiation to as many people as possible. Not only the media such as television and the press should be used, but all radiation professionals who have contacts with the public, such as radiologists, radiotherapists, physicists and teacher
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Ronquillo, Jay G; Zuckerman, Diana M
2017-09-01
Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review
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Rangel-S, Maria Ligia
2007-01-01
This paper discusses communication as a technology for risk control with health and safety protection and promotion, within the context of a "risk society". As a component of Risk Analysis, risk communication is a technology that appears in risk literature, with well defined objectives, principles and models. These aspects are described and the difficulties are stressed, taking into consideration the multiple rationales related to risks in the culture and the many different aspects of risk regulation and control in the so-called "late modernity". Consideration is also given to the complexity of the communications process, guided by theoretical and methodological discussions in the field. In order to understand the true value of the communications field for risk control with health and safety protection and promotion, this paper also offers an overview of communication theories that support discussions of this matter, proposing a critical approach to models that include the dimensions of power and culture in the context of a capitalist society.
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78 FR 42701 - Improving Public Safety Communications in the 800 MHz Band
2013-07-17
...] Improving Public Safety Communications in the 800 MHz Band AGENCY: Federal Communications Commission. ACTION...-901 MHz/935- 940 MHz band (900 MHz B/ILT Band) to allow a qualified entity to file an application for..., manufacturing, energy) to non-commercial (e.g., clerical, educational, philanthropic, medical). In 2004, the...
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Kaskutas, Vicki; Dale, Ann Marie; Lipscomb, Hester; Evanoff, Brad
2013-02-01
Falls from heights account for 64% of residential construction worker fatalities and 20% of missed work days. We hypothesized that worker safety would improve with foremen training in fall prevention and safety communication. Training priorities identified through foreman and apprentice focus groups and surveys were integrated into an 8-hour training. We piloted the training with ten foremen employed by a residential builder. Carpenter trainers contrasted proper methods to protect workers from falls with methods observed at the foremen's worksites. Trainers presented methods to deliver toolbox talks and safety messages. Results from worksite observational audits (n=29) and foremen/crewmember surveys (n=97) administered before and after training were compared. We found that inexperienced workers are exposed to many fall hazards that they are often not prepared to negotiate. Fall protection is used inconsistently and worksite mentorship is often inadequate. Foremen feel pressured to meet productivity demands and some are unsure of the fall protection requirements. After the training, the frequency of daily mentoring and toolbox talks increased, and these talks became more interactive and focused on hazardous daily work tasks. Foremen observed their worksites for fall hazards more often. We observed increased compliance with fall protection and decreased unsafe behaviors during worksite audits. Designing the training to meet both foremen's and crewmembers' needs ensured the training was learner-centered and contextually-relevant. This pilot suggests that training residential foremen can increase use of fall protection, improve safety behaviors, and enhance on-the-job training and safety communication at their worksites. Construction workers' training should target safety communication and mentoring skills with workers who will lead work crews. Interventions at multiple levels are necessary to increase safety compliance in residential construction and decrease falls
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Anderson, Paul A; Nassr, Ahmad; Currier, Bradford L; Sebastian, Arjun S; Arnold, Paul M; Fehlings, Michael G; Mroz, Thomas E; Riew, K Daniel
2017-04-01
Systematic review and meta-analysis. The safety of new technology such as cervical total disc replacement (TDR) is of paramount importance and is best evaluated in randomized clinical trials (RCT). We compared complication risks of TDR to fusion using data from Investigational Device Exemptions. A systematic review of FDA Summary of Safety and Effectiveness reports of the 8 approved cervical TDRs was performed. These were all randomized controlled trials comparing anterior cervical discectomy and fusion (ACDF) to TDR. Important outcome variables were dysphagia, wound infection, neurologic injuries, heterotopic ossification, death, and secondary surgeries. A random effects model was selected a priori. Data on adverse events was abstracted and analyzed by calculating relative risk of ACDF to TDR by meta-analysis techniques. The study included 3027 patients with 1377 randomized to ACDF and 1652 to TDR. No statistical differences were present between the 2 groups in dysphagia/dysphonia, hardware related, heterotopic ossification, death, and overall neurologic adverse events and incidence of neurologic deterioration. The relative risk of wound-related problems ACDF to TDR was 0.76 (95% confidence interval [CI] = 0.59, 0.98) favoring ACDF, which was statistically significant, but these were minor and never required a second surgical procedure for deep wound infection. The relative risk of ACDF to TDR in surgical-related neurologic events and secondary surgeries was 1.62 (95% CI = 1.04, 2.53) and 1.79 (95% CI = 1.17, 2.74), both favoring TDR. Cervical TDR appears to be as safe as or safer than ACDF at 2-year follow-up.
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The importance of online communication in the information upon safety and security at work
Directory of Open Access Journals (Sweden)
Chiţu Ioana Bianca
2017-07-01
Full Text Available This study aims at presenting the employees’ opinions on the use of online environment as a medium for communicating the information related to labour safety and security. The study is based on a quantitative marketing research achieved by interviewing 95 participants, within a conference on labour safety and security. The idea of conducting this research was based on the increasing number of internet users in our country, as well as on the fact that the young generations are ever more dependent on the communication in the online environment, to the detriment of the communication by classical promotional media.
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2010-09-29
The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.
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Pharmaceutical company perspectives on current safety risk communications in Japan.
Urushihara, Hisashi; Kobashi, Gen; Masuda, Hideaki; Taneichi, Setsuko; Yamamoto, Michiko; Nakayama, Takeo; Kawakami, Koji; Matsuda, Tsutomu; Ohta, Kaori; Sugimori, Hiroki
2014-01-01
In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, the Government of Japan established a responding inspection committee in 2008 to make recommendations for the restructuring of drug regulatory administration. The final report was issued in 2010. One agenda item of this restructuring was the improvement of drug-related safety risk communications. Our research group on drug safety risk communications, which is funded by the Government of Japan, surveyed pharmaceutical companies regarding their perspective on current risk communications. The survey was conducted using an anonymous questionnaire developed for this study which included the three operational domains of targets, contents, and measures of drug risk communication. Fifty-two of the 74 member companies of the Post-marketing Surveillance Subcommittee of the Japan Pharmaceutical Manufacturer's Association participated, and this response rate of more than 70% was considered sufficient to ensure the external validity of the survey results. Results showed that the most highly prioritized aspect of risk messaging was the strength of evidence, and that outcome evaluation of risk communication gained recognition. Further, while physicians and pharmacists were the most prioritized communication targets, pharmacovigilance departments devoted the most resources to regulators, at more than 30%. The Internet was recognized as a useful public source of risk information, whereas Drug Guides for Patients delivered on the web were considered under-recognized. Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted.
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International Nuclear Information System (INIS)
1999-01-01
The technical aspects of confidence have been the subject of considerable debate, especially the concept of model validation. The safety case that is provided at a particular stage in the planning, construction, operation or closure of a deep geological repository is a part of a broader decision basis that guides the repository-development process. The basic steps for deriving the safety case at various stages of repository development involve: a safety assessment; and the documentation of the safety assessment, a statement of confidence in the safety indicated by the assessment, and the confirmation of the appropriateness of the safety strategy. The approaches to establish confidence in the evaluation of safety should aim to ensure that the decisions taken within the incremental process of repository development are well-founded. Various aspects of confidence in the evaluation of safety, and their integration within a safety case, are presented in detail in the present report. When communicating confidence in the findings of a safety assessment, clarity in the communication of concepts is always required. Consistent with this requirement, key concepts are specifically defined in the main text of the report. (R.P.)
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Effective physician-nurse communication: a patient safety essential for labor and delivery.
Lyndon, Audrey; Zlatnik, Marya G; Wachter, Robert M
2011-08-01
Effective communication is a hallmark of safe patient care. Challenges to effective interprofessional communication in maternity care include differing professional perspectives on clinical management, steep hierarchies, and lack of administrative support for change. We review principles of high reliability as they apply to communication in clinical care and discuss principles of effective communication and conflict management in maternity care. Effective clinical communication is respectful, clear, direct, and explicit. We use a clinical scenario to illustrate an historic style of nurse-physician communication and demonstrate how communication can be improved to promote trust and patient safety. Consistent execution of successful communication requires excellent listening skills, superb administrative support, and collective commitment to move past traditional hierarchy and professional stereotyping. Copyright © 2011 Mosby, Inc. All rights reserved.
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Karanikas, N.; Melis, Damien Jose; Kourousis, Kyriakos
2017-01-01
Background: This paper presents the findings of a pilot research survey which assessed the degree of balance between safety and productivity, and its relationship with awareness and communication of human factors and safety rules in the aircraft manufacturing environment. Methods: The study was
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Changes In Growth Culture FDA Activity Under Changing Growth Conditions
DEFF Research Database (Denmark)
Jørgensen, Per Elberg; Eriksen, Thomas Juul; Jensen, Bjørn K.
1992-01-01
The FDA hydrolysis capacities and bacterial biomass concentrations (estimated by determination of ATP content) of growth cultures prepared from activated sludge and wastewater, were measured to find out whether the FDA activity would reflect bacterial biomass under different physiological states...... of the bacteria. The FDA activity/ATP ratio was calculated for different concentrations of autoclaved sludge. A faster decay rate of ATP relative to FDA hydrolysis activity was observed, thus causing changes in the ratio. Furthermore, comparison between values obtained from pure cultures and different soils...... revealed differences up to two orders of magnitude of the ratio. Based on these results it was concluded that the FDA activity should not be applied for measurements of viable biomass in environments in which different physiological conditions occur....
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Subarray-based FDA radar to counteract deceptive ECM signals
Abdalla, Ahmed; Wang, Wen-Qin; Yuan, Zhao; Mohamed, Suhad; Bin, Tang
2016-12-01
In recent years, the frequency diverse array (FDA) radar concept has attracted extensive attention, as it may benefit from a small frequency increment, compared to the carrier frequency across the array elements and thereby achieve an array factor that is a function of the angle, the time, and the range which is superior to the conventional phase array radar (PAR). However, limited effort on the subject of FDA in electronic countermeasure scenarios, especially in the presence of mainbeam deceptive jamming, has been published. Basic FDA is not desirable for anti-jamming applications, due to the range-angle coupling response of targets. In this paper, a novel method based on subarrayed FDA signal processing is proposed to counteract deceptive ECM signals. We divide the FDA array into multiple subarrays, each of which employs a distinct frequency increment. As a result, in the subarray-based FDA, the desired target can be distinguished at subarray level in joint range-angle-Doppler domain by utilizing the fact that the jammer generates false targets with the same ranges to each subarray without reparations. The performance assessment shows that the proposed solution is effective for deceptive ECM targets suppression. The effectiveness is verified by simulation results.
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76 FR 44017 - Risk Communication Advisory Committee; Notice of Meeting
2011-07-22
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... and former members of the Risk Communication Advisory Committee. FDA intends to make background...
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Challenges of communicating safety case results to different audiences
International Nuclear Information System (INIS)
Hocke, Peter; Roehlig, Klaus-Juergen
2014-01-01
Nowadays, nuclear politics and decision making are often oriented at procedures which are linked to precautionary concepts and which reflect forms of 'knowledge politics'. These precautionary concepts in most cases focus on robust societal decisions, which incorporate the principles of sustainability as a topic of public debate. The issue of high-level nuclear waste is under debate and confronted with public discourse, which integrates not only the knowledge of different stakeholders, but also accept certain forms of 'Nichtwissen' ('non-knowledge'). Interdisciplinary research has to observe these normative trends and also has to 'contextualise' these questions before interpreting its research results for giving answers with practical relevance, especially in communication with different social actors. Issues which are brought up in this field of nuclear waste management and their social context have to be analysed in two dimensions: i) the dimension of professionalism and expertise; ii) the dimension of managing controversial debates ('knowledge politics') and the preparation and implementing of robust decisions mostly by responsible governmental organisations. In this context on the one hand complex aspects of safety have to be communicated in their internal scientific logic and structure. On the other hand the different functional systems and collective actors of highly differentiated modern societies are engaged in controversial debates on advanced technologies like nuclear energy and technologies for waste disposal over long-lasting time periods. Most safety and construction issues for final disposal of high-level waste, but also of waste management in general, are debated within professional 'communities' of scientists and experts. But if their technological artefacts and their conceptual planning become issues of controversial and political debates in spheres which are outside the closed circle of high-level professionals and party politicians (who are in the
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Crisis Communication Competence in Co-Producing Safety with Citizen Groups
Directory of Open Access Journals (Sweden)
Anne Laajalahti
2016-03-01
Full Text Available The aim of this article is to explore interpersonal communication competence needed by crisis communication and management experts when co-operating with citizen groups in response to emergencies. Moreover, the purpose is to understand how response organizations can further develop this crisis communication competence and so contribute to the functioning of response networks. The research task is approached qualitatively by eliciting crisis communication and management experts’ (n = 33 perceptions of the interpersonal communication competence response organizations needs when co-operating with citizen groups. The data were gathered via an international online questionnaire using a method referred to as “thematic writing” and consist of written responses to open-ended questions on what constitutes the core of crisis communication competence and what aspects of it need more attention. The research findings indicate that co-producing safety with citizen groups demands crisis communication competence related to message production, message reception, and interaction between experts and citizen groups. In addition, the findings clarify what areas of crisis communication competence need to be further developed to facilitate co-operation between experts and citizen groups. However, the authors suggest that crisis communication competence should not be seen solely as a characteristic of individual crisis communicators but approached as a networked and co-created area of competence.
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Communications on nuclear, radiation, transport and waste safety: a practical handbook
International Nuclear Information System (INIS)
1999-04-01
Basic requirements to be met by national infrastructures for radiation protection and safety are stated in the International basic safety Standards for Protection against Ionizing radiation and for safety of radiation Sources. These include a requirement 'to set up appropriate means of informing the public, its representatives and the information media about the health and safety aspects of activities involving exposure to radiation and about regulatory processes.' This publication is intended for national regulatory authorities, to provide them with guidance on the principles and methods that can be applied in communicating nuclear safety to different audiences under different circumstances. This report presumes the existence of adequate national infrastructure including an independent regulatory authority with sufficient powers and resources to meet its responsibilities
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76 FR 16427 - Risk Communication Advisory Committee; Notice of Meeting
2011-03-23
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss developments in FDA's ongoing communications programs. The discussion will focus on the use of...
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75 FR 20608 - Risk Communication Advisory Committee; Notice of Meeting
2010-04-20
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... relevant to improving risk communication at FDA, and discuss applications or gaps for strategic planning of...
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2012-11-27
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal... Security, Reliability, and Interoperability Council (CSRIC III) scheduled for December 5, 2012, at Federal...
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The safety and regulation of natural products used as foods and food ingredients.
Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J
2011-10-01
The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements.
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76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry
2011-01-07
...] FDA Transparency Initiative: Improving Transparency to Regulated Industry AGENCY: Food and Drug... the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The...
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Directory of Open Access Journals (Sweden)
Gil Amarilyo
Full Text Available Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA which independently analyzes the raw data and reports the results on its website.This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis.Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy and withdrawal due to adverse events (safety. As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report, followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy.FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34 except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61 pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55 pairwise comparisons and were statistically significant in 5. The "signal" in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical.There was no empirical evidence to suggest biased estimates between the two
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21 CFR 312.86 - Focused FDA regulatory research.
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency...
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Issue on NPP-I and C important to safety-Data Communication
International Nuclear Information System (INIS)
Koo, I. S.; Hong, S. B.; Cho, J. W.; Choi, Y. S.; Lee, J. C.
2010-01-01
1. Issue on CDV and FDIS of IEC61500 - Nuclear Power Plants - Instrumentation and control important to safety -Data communication - Activities on IEC TC45, SC45A/WGA3. 2. As issue the requirements for safety data communication which is essential part of digital I and C systems, the fundamental technology for IT based nuclear I and C is established. 3. Approval and circulation of IED61500 CDV and FDIS - Issue of the international standard, IEC 61500. 4. Issue one IEC61500, three interim documents, three presentations and five technical support to industry, and participation in IEC TC45 and SC45A plenary meeting and intermediate meeting on SC45A/WGA3. 5. Based on IEC61500, an new project on wireless technologyes application to NPP will be proceeded
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2011-10-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0529] Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business... amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). In particular...
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2011-08-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0529] Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business... burden of fee amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA...
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Interprofessional education in team communication: working together to improve patient safety.
Brock, Douglas; Abu-Rish, Erin; Chiu, Chia-Ru; Hammer, Dana; Wilson, Sharon; Vorvick, Linda; Blondon, Katherine; Schaad, Douglas; Liner, Debra; Zierler, Brenda
2013-05-01
Communication failures in healthcare teams are associated with medical errors and negative health outcomes. These findings have increased emphasis on training future health professionals to work effectively within teams. The Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) communication training model, widely employed to train healthcare teams, has been less commonly used to train student interprofessional teams. The present study reports the effectiveness of a simulation-based interprofessional TeamSTEPPS training in impacting student attitudes, knowledge and skills around interprofessional communication. Three hundred and six fourth-year medical, third-year nursing, second-year pharmacy and second-year physician assistant students took part in a 4 h training that included a 1 h TeamSTEPPS didactic session and three 1 h team simulation and feedback sessions. Students worked in groups balanced by a professional programme in a self-selected focal area (adult acute, paediatric, obstetrics). Preassessments and postassessments were used for examining attitudes, beliefs and reported opportunities to observe or participate in team communication behaviours. One hundred and forty-nine students (48.7%) completed the preassessments and postassessments. Significant differences were found for attitudes toward team communication (pskills included, team structure (p=0.002), situation monitoring (pcommunication (p=0.002). Significant shifts were reported for knowledge of TeamSTEPPS (pcommunicating in interprofessional teams (pcommunication is important in patient safety. We demonstrate positive attitudinal and knowledge effects in a large-scale interprofessional TeamSTEPPS-based training involving four student professions.
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Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael
2013-01-22
The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5
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Yu, Sheila; Escobedo, Patricia; Garcia, Robert; Cruz, Tess Boley; Unger, Jennifer B; Baezconde-Garbanati, Lourdes; Meza, Leah; Sussman, Steve
2018-02-11
After proposing the "Deeming Rule" in 2014, the U.S. Food and Drug Administration (FDA) began regulating the manufacturing, marketing, and sales of electronic cigarette (e-cigarette) products as tobacco products in 2016. The current study conducted vape shop store observations and surveyed Los Angeles-area shop employees (assessing their beliefs, awareness, and perceptions of e-cigarettes and related FDA regulations) at two time points one year apart to better understand what vape shop retailers would do given FDA's soon-to-be-enacted Deeming Rule. The study also compared retailer beliefs/awareness/actions and store characteristics immediately after the Deeming Rule proposal versus a year after the Rule had been proposed, right before its enactment. Two data collection waves occurred before the Deeming Rule enactment, with Year 1 surveying 77 shops (2014) and Year 2 surveying 61 shops (2015-2016). Between the data collection points, 16 shops had closed. Among the shops that were open at both time points, the majority (95% in Year 1; 74% in Year 2) were aware of some FDA regulations or other policies applying to vape shops. However, overall awareness of FDA regulations and state/local policies governing e-cigarettes significantly decreased from Year 1 to Year 2. At both time points, all shops offered customers free puffs of nicotine-containing e-liquids (prohibited by the then upcoming Deeming Rule). Perceptions of e-cigarette safety also significantly decreased between the years. Exploring vape shop retailer perceptions and store policies (i.e., free puffs/samples displays, perceptions of e-cigarette safety, etc.) over time will help the FDA assess the needs of the vape shop community and develop more effective retailer education campaigns and materials targeted to increase compliance with the newly enacted regulations.
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2010-08-06
...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of... product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and...
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Gottlieb, the FDA and dumbing down medicine
Robbins RA
2017-01-01
No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some wh...
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Huls, Dale Thomas
2005-12-01
Blogs are an increasingly dominant new communication function on the internet. The power of this technology has forced media, corporations and government organizations to begin to incorporate blogging into their normal business practices. Blogs could be a key component to overcoming NASA's "silent safety culture." As a communications tool, blogs are used to establish trust primarily through the use of a personal voice style of writing. Dissenting voices can be raised and thoroughly vetted via a diversity of participation and experience without peer pressure or fear of retribution. Furthermore, the benefits of blogging as a technical resource to enhance safety are also discussed. The speed and self-vetting nature of blogging can allow managers and decision-makers to make more informed and therefore potentially better decisions with regard to technical and safety issues. Consequently, it is recommended that NASA utilize this new technology as an agent for cultural change.
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Palley, H A
1995-01-01
The central issue facing federal regulation of breast implants is that while such devices are not functionally necessary or needed for survival, the side effects may be harmful and have not been proven unharmful. The Medical Device Amendments of 1976 appear to require such evidence prior to the FDA permitting the unrestricted marketing of these devices. However, only recently have such requirements been imposed by the FDA. The author examines the FDA's decision-making process, particularly as applied to silicone breast implants, and the factors that appears to have affected such decisions. In pursuing this study, the activities of a number of interest-group actors, as well as congressional responses and the role of federal bureaucratic actors, were examined. In 1992, the FDA established a regulatory protocol that effectively withdrew most silicone breast implants from the market for the purpose of breast augmentation and allows for the monitoring of the impact of new implants on women's health. This increase concern for determining the safety of breast implants is due to a number of factors, which are examined in this article.
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Malone, Roy W.; Livingston, John M.
2010-01-01
The paper describes the role of technical excellence and communication in the development and maintenance of safety and mission assurance programs. The Marshall Space Flight Center (MSFC) Safety and Mission Assurance (S&MA) organization is used to illustrate philosophies and techniques that strengthen safety and mission assurance efforts and that contribute to healthy and effective organizational cultures. The events and conditions leading to the development of the MSFC S&MA organization are reviewed. Historic issues and concerns are identified. The adverse effects of resource limitations and risk assessment roles are discussed. The structure and functions of the core safety, reliability, and quality assurance functions are presented. The current organization s mission and vision commitments serve as the starting points for the description of the current organization. The goals and objectives are presented that address the criticisms of the predecessor organizations. Additional improvements are presented that address the development of technical excellence and the steps taken to improve communication within the Center, with program customers, and with other Agency S&MA organizations.
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Malone, Roy W.; Livingston, John M.
2010-09-01
The paper describes the role of technical excellence and communication in the development and maintenance of safety and mission assurance programs. The Marshall Space Flight Center(MSFC) Safety and Mission Assurance(S&MA) organization is used to illustrate philosophies and techniques that strengthen safety and mission assurance efforts and that contribute to healthy and effective organizational cultures. The events and conditions leading to the development of the MSFC S&MA organization are reviewed. Historic issues and concerns are identified. The adverse effects of resource limitations and risk assessment roles are discussed. The structure and functions of the core safety, reliability, and quality assurance functions are presented. The current organization’s mission and vision commitments serve as the starting points for the description of the current organization. The goals and objectives are presented that address the criticisms of the predecessor organizations. Additional improvements are presented that address the development of technical excellence and the steps taken to improve communication within the Center, with program customers, and with other Agency S&MA organizations.
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Gottlieb, the FDA and dumbing down medicine
Directory of Open Access Journals (Sweden)
Robbins RA
2017-04-01
Full Text Available No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1. Others praised Gottlieb as the right man to lead the FDA. As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2. Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight …
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42 CFR 405.203 - FDA categorization of investigational devices.
2010-10-01
... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational.../investigational (Category A) or non-experimental/investigational (Category B). (c) CMS uses the categorization of...
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Drug safety: Pregnancy rating classifications and controversies.
Wilmer, Erin; Chai, Sandy; Kroumpouzos, George
2016-01-01
This contribution consolidates data on international pregnancy rating classifications, including the former US Food and Drug Administration (FDA), Swedish, and Australian classification systems, as well as the evidence-based medicine system, and discusses discrepancies among them. It reviews the new Pregnancy and Lactation Labeling Rule (PLLR) that replaced the former FDA labeling system with narrative-based labeling requirements. PLLR emphasizes on human data and highlights pregnancy exposure registry information. In this context, the review discusses important data on the safety of most medications used in the management of skin disease in pregnancy. There are also discussions of controversies relevant to the safety of certain dermatologic medications during gestation. Copyright © 2016 Elsevier Inc. All rights reserved.
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FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files
U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...
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International Nuclear Information System (INIS)
Hah, Yeon Hee; Chung, Yun Hyung; Lee, Gey Hwi; Choi, Yong Seog
2006-01-01
The fundamental objective of nuclear regulatory organization is to ensure that nuclear activities are conducted at all times in an acceptably safe manner. When we are talking about 'acceptable' safety, it means that we have to try to achieve the safety level as 'acceptable' as perceived by the public, not the one conceptualized by the technology itself. In meeting this objective, the regulatory organization continues to ensure that its activities are transparent, technically sound, credible, and independent. More importantly, it should strive to ensure that the public are well informed about such activities and are confident upon regulatory organization. Public communication is one of the key approaches to attain such a goal. The availability of on-line communications based on the development of information technology has made a major impact on the public's better awareness of nuclear safety issues. Nuclear regulatory organization and operators are increasingly under pressure to communicate more actively with the public to satisfy their demand for knowing about the safety of nuclear facility. In coping with such challenges, KINS has developed a public information and communication policy to make public confident in their information and thus to earn the public trust and confidence toward nuclear safety. It is widely acknowledged that public communication for ensuring nuclear safety has been an integral part of the operators' activity. However, the roles and activities by the regulator in the area of public communication are increasingly required as the public become more interested in and concerned about safety issues. Taking this into account, KINS has carried out several activities to be well-informed about how the public perceive nuclear safety and how much they are satisfied with the regulator's activities, etc
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Healthy public relations: the FDA's 1930s legislative campaign.
Kay, G
2001-01-01
In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more.
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Adverse event reporting in Slovenia - the influence of safety culture, supervisors and communication
Directory of Open Access Journals (Sweden)
Birk Karin
2016-01-01
Full Text Available Background/Aim. The provision of safe healthcare is considered a priority in European Union (EU member states. Along with other preventative measures in healthcare, the EU also strives to eliminate the “causes of harm to human health”. The aim of this survey was to determine whether safety culture, supervisors and communication between co-workers influence the number of adverse event reports submitted to the heads of clinical departments and to the management of an institution. Methods. This survey is based on cross-sectional analysis. It was carried out in the largest Slovenian university hospital. We received 235 completed questionnaires. Respondents included professionals in the fields of nursingcare, physiotherapy, occupational therapy and radiological technology. Results. Safety culture influences the number of adverse event reports submitted to the head of a clinical department from the organizational point of view. Supervisors and communication between co-workers do not influence the number of adverse event reports. Conclusion. It can be concluded that neither supervisors nor the level of communication between co-workers influence the frequency of adverse event reporting, while safety culture does influence it from an organizational point of view. The presumed factors only partly influence the number of submitted adverse event reports, thus other causes of under-reporting must be sought elsewhere.
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Lee, Peter; Allen, Kellie; Daly, Michael
2012-01-01
Communication breakdown is a factor contributing to most cases of patient harm, and this harm continues to occur at unacceptable levels. Responding to this evidence, the Metro South District of Queensland Health (Australia) has developed a communication skills training programme titled 'Communication and Patient Safety'. The three modules, each lasting 3½ h, cover both staff-to-patient and staff-to-staff communication issues, and an unusual feature is that clinical and non-clinical staff attend together. Following positive evaluation data from our initial pilot programme (involving 350 staff in a single hospital), the programme was expanded to all five hospitals in the district, and has now been completed by over 3000 staff. The results show that despite the significant time commitment, participants find the courses useful and relevant (Kirkpatrick level 1), they learn and retain new material (level 2), and they report changes in behaviour at individual, team and facility levels (level 3). Although it remains a challenge to obtain quantitative data showing that training such as this directly improves patient safety (level 4), our qualitative and informal feedback indicates that participants and their managers perceive clear improvements in the 'communication culture' after a workplace team has attended the courses. Improving 'communication for safety' in healthcare is a worldwide imperative, and other healthcare jurisdictions should be able to obtain similar results to ours if they develop and support interactive, non-didactic training in communication skills.
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Evolving US Food Safety Regulations and International Competitors: Implementation Dynamics
Directory of Open Access Journals (Sweden)
Tekuni Nakuja
2015-12-01
Full Text Available The 2011 US Food Safety Modernization Act (FSMA represents a major initiative to improve food safety. The legislation mandates the US Food and Drug Administration (FDA with developing a regulatory system to implement the Act. Both domestic and foreign firms that wish to supply US consumers with food will face a considerable increase in regulatory costs. Implementation has proved challenging for the FDA leading to delays which increase investment risks for foreign suppliers, particulalry from developing countries. This paper sets out the major FSMA requirements and examines how the regulatory burden may fall on foreign versus US suppliers.
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Directory of Open Access Journals (Sweden)
Sheila Yu
2018-02-01
Full Text Available After proposing the “Deeming Rule” in 2014, the U.S. Food and Drug Administration (FDA began regulating the manufacturing, marketing, and sales of electronic cigarette (e-cigarette products as tobacco products in 2016. The current study conducted vape shop store observations and surveyed Los Angeles–area shop employees (assessing their beliefs, awareness, and perceptions of e-cigarettes and related FDA regulations at two time points one year apart to better understand what vape shop retailers would do given FDA’s soon-to-be-enacted Deeming Rule. The study also compared retailer beliefs/awareness/actions and store characteristics immediately after the Deeming Rule proposal versus a year after the Rule had been proposed, right before its enactment. Two data collection waves occurred before the Deeming Rule enactment, with Year 1 surveying 77 shops (2014 and Year 2 surveying 61 shops (2015–2016. Between the data collection points, 16 shops had closed. Among the shops that were open at both time points, the majority (95% in Year 1; 74% in Year 2 were aware of some FDA regulations or other policies applying to vape shops. However, overall awareness of FDA regulations and state/local policies governing e-cigarettes significantly decreased from Year 1 to Year 2. At both time points, all shops offered customers free puffs of nicotine-containing e-liquids (prohibited by the then upcoming Deeming Rule. Perceptions of e-cigarette safety also significantly decreased between the years. Exploring vape shop retailer perceptions and store policies (i.e., free puffs/samples displays, perceptions of e-cigarette safety, etc. over time will help the FDA assess the needs of the vape shop community and develop more effective retailer education campaigns and materials targeted to increase compliance with the newly enacted regulations.
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Transforming communication and safety culture in intrapartum care: a multi-organization blueprint.
Lyndon, Audrey; Johnson, M Christina; Bingham, Debra; Napolitano, Peter G; Joseph, Gerald; Maxfield, David G; OʼKeeffe, Daniel F
2015-05-01
Effective, patient-centered communication facilitates interception and correction of potentially harmful conditions and errors. All team members, including women, their families, physicians, midwives, nurses, and support staff, have a role in identifying the potential for harm during labor and birth. However, the results of collaborative research studies conducted by organizations that represent professionals who care for women during labor and birth indicate that health care providers may frequently witness, but may not always report, problems with safety or clinical performance. Some of these health care providers felt resigned to the continuation of such problems and fearful of retribution if they tried to address them. Speaking up to address safety and quality concerns is a dynamic social process. Every team member must feel empowered to speak up about concerns without fear of put-downs, retribution, or receiving poor-quality care. Patient safety requires mutual accountability: individuals, teams, health care facilities, and professional associations have a shared responsibility for creating and sustaining environments of mutual respect and engaging in highly reliable perinatal care. Defects in human factors, communication, and leadership have been the leading contributors to sentinel events in perinatal care for more than a decade. Organizational commitment and executive leadership are essential to creating an environment that proactively supports safety and quality. The problem is well-known; the time for action is now.
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... Drug Safety and Availability FDA Drug Safety Communication: Risk of oral clefts in children born to mothers ... data that show that there is an increased risk for the development of cleft lip and/or ...
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78 FR 70954 - Risk Communications Advisory Committee; Notice of Meeting
2013-11-27
... awareness and understanding of the key risk messages, as well as whether the communications are having the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Risk Communications Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...
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Directory of Open Access Journals (Sweden)
Nguyen Diane
2013-01-01
Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by
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How to communicate safety? Some reflections from European project studies
International Nuclear Information System (INIS)
Richardson, Philip; Galson, Daniel
2009-12-01
Attempts to site geological disposal facilities for radioactive waste - and associated public reactions - indicate that communicating safety and demonstrating safety are very different things. The three different approaches to stakeholder engagement undertaken in the context of the PAMINA, ARGONA and CIP projects have provided valuable insights into how risk communication processes and tools can be improved. The approaches used in these projects all involve the participation of interested stakeholders in identifying concerns and issues, which are then examined in a co-operative fashion between stakeholders and developers acting in partnership. Such approaches offer avenues for dialogue and confidence building where such channels were previously not well developed, Full results from the projects will be available in late 2009 for PAMINA and ARGONA and in early 2010 for CIP. The comments and interim insights outlined here will be developed further and incorporated in the overall project outputs, and help inform developing European policy in this area. It is already clear, however, that the approaches used in these projects offer great promise in helping to develop the trust in the institutions and organisations involved that is essential in gaining support and acceptance for the waste management activities now underway across Europe
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Directory of Open Access Journals (Sweden)
Peng Jing
2017-10-01
Full Text Available With the unparalleled growth of motor vehicles, traffic accident between pedestrians and vehicles is one of the most serious issues in the word-wild. Plenty of injuries and fatalities are caused by the traffic accidents and crashes. The connected vehicular ad hoc network as an emerging approach which has the potential to reduce and even avoid accidents have been focused on by many researchers. A large number of car-to-pedestrian communication safety systems based on the vehicular ad hoc network are researching and developing. However, to our limited knowledge, a systematic review about the car-to-pedestrian communication safety system based on the vehicular ad-hoc network has not be written. The purpose and goal of this review is to systematically evaluate and access the reliability of car-to-pedestrian communication safety system based on the vehicular ad-hoc network environment and provide some recommendations for the future works according to throwing some light on the previous literatures. A quality evaluation was developed through established items and instruments tailored to this review. Future works are needed to focus on developing a valid as well as effective communication safety system based on the vehicular ad hoc network to protect the vulnerable road users.
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Energy Technology Data Exchange (ETDEWEB)
Brown, R.V.; Ulvila, J.W.
1988-06-01
An approach to communicating decision and risk analysis findings to managers is illustrated in a real case context. This article consists essentially of a report prepared for senior managers of the Nuclear Regulatory Commission to help them make a reactor safety decision. It illustrates the communication of decision analysis findings relating to technical risks, costs, and benefits in support of a major risk management decision: whether or not to require a safety backfit. Its focus is on the needs of decision makers, and it introduces some novel communication devices.
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Reliability modeling of safety-critical network communication in a digitalized nuclear power plant
International Nuclear Information System (INIS)
Lee, Sang Hun; Kim, Hee Eun; Son, Kwang Seop; Shin, Sung Min; Lee, Seung Jun; Kang, Hyun Gook
2015-01-01
The Engineered Safety Feature-Component Control System (ESF-CCS), which uses a network communication system for the transmission of safety-critical information from group controllers (GCs) to loop controllers (LCs), was recently developed. However, the ESF-CCS has not been applied to nuclear power plants (NPPs) because the network communication failure risk in the ESF-CCS has yet to be fully quantified. Therefore, this study was performed to identify the potential hazardous states for network communication between GCs and LCs and to develop quantification schemes for various network failure causes. To estimate the risk effects of network communication failures in the ESF-CCS, a fault-tree model of an ESF-CCS signal failure in the containment spray actuation signal condition was developed for the case study. Based on a specified range of periodic inspection periods for network modules and the baseline probability of software failure, a sensitivity study was conducted to analyze the risk effect of network failure between GCs and LCs on ESF-CCS signal failure. This study is expected to provide insight into the development of a fault-tree model for network failures in digital I&C systems and the quantification of the risk effects of network failures for safety-critical information transmission in NPPs. - Highlights: • Network reliability modeling framework for digital I&C system in NPP is proposed. • Hazardous states of network protocol between GC and LC in ESF-CCS are identified. • Fault-tree model of ESF-CCS signal failure in ESF actuation condition is developed. • Risk effect of network failure on ESF-CCS signal failure is analyzed.
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Doblin, Rick
2002-01-01
The FDA and the Spanish Ministry of Health have concluded that the risk/benefit ratio is favorable under certain circumstances for clinical studies investigating MDMA-assisted psychotherapy. Both agencies have approved pilot studies in chronic posttraumatic stress disorder (PTSD) patients who have failed to obtain relief from at least one course of conventional treatment. These studies, the only ones in the world into the therapeutic use of MDMA, are being funded by a nonprofit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org). A rationale is offered explaining why MAPS chose to focus its limited resources on MDMA, and also on PTSD patients. A Clinical Plan is elaborated for the conduct of the "adequate and well-controlled" trials necessary to evaluate the safety and efficacy of MDMA-assisted psychotherapy for PTSD, with the studies estimated to cost about 5 million dollars and to take about five years. The Clinical Plan has been developed, in part, through analysis of the studies conducted by Pfizer in its successful effort to have Zoloft approved by the FDA for use with PTSD patients, and through review of transcripts of the FDA's Psychopharmacologic Drugs Advisory Committee meeting that recommended approval of Zoloft for PTSD.
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Safety and security profiles of industry networks used in safety- critical applications
Directory of Open Access Journals (Sweden)
Mária FRANEKOVÁ
2008-01-01
Full Text Available The author describes the mechanisms of safety and security profiles of industry and communication networks used within safety – related applications in technological and information levels of process control recommended according to standards IEC 61784-3,4. Nowadays the number of vendors of the safety – related communication technologies who guarantees besides the standard communication, the communication amongst the safety – related equipment according to IEC 61508 is increasing. Also the number of safety – related products is increasing, e. g. safety Fieldbus, safety PLC, safety curtains, safety laser scanners, safety buttons, safety relays and other. According to world survey the safety Fieldbus denoted the highest growth from all manufactured safety products.The main part of this paper is the description of the safety-related Fieldbus communication system, which has to guaranty Safety Integrity Level.
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International Nuclear Information System (INIS)
2002-01-01
Confidence among both technical experts and the public in the safety of deep geologic repositories for radioactive waste is a key element in the successful development of the repositories. This report presents the approaches and arguments that are currently used in OECD countries to establish and communicate confidence in their safety. It evaluates the state of the art for obtaining, presenting and demonstrating confidence in long-term safety, and makes recommendations on future directions and initiatives to be taken for improving confidence. (author)
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Schickedanz, Adam; Huang, David; Lopez, Andrea; Cheung, Edna; Lyles, C R; Bodenheimer, Tom; Sarkar, Urmimala
2013-07-01
Electronic and internet-based tools for patient-provider communication are becoming the standard of care, but disparities exist in their adoption among patients. The reasons for these disparities are unclear, and few studies have looked at the potential communication technologies have to benefit vulnerable patient populations. To characterize access to, interest in, and attitudes toward internet-based communication in an ethnically, economically, and linguistically diverse group of patients from a large urban safety net clinic network. Observational, cross-sectional study Adult patients (≥ 18 years) in six resource-limited community clinics in the San Francisco Department of Public Health (SFDPH) MAIN MEASURES: Current email use, interest in communicating electronically with health care professionals, barriers to and facilitators of electronic health-related communication, and demographic data-all self-reported via survey. Sixty percent of patients used email, 71 % were interested in using electronic communication with health care providers, and 19 % reported currently using email informally with these providers for health care. Those already using any email were more likely to express interest in using it for health matters. Most patients agreed electronic communication would improve clinic efficiency and overall communication with clinicians. A significant majority of safety net patients currently use email, text messaging, and the internet, and they expressed an interest in using these tools for electronic communication with their medical providers. This interest is currently unmet within safety net clinics that do not offer a patient portal or secure messaging. Tools such as email encounters and electronic patient portals should be implemented and supported to a greater extent in resource-poor settings, but this will require tailoring these tools to patients' language, literacy level, and experience with communication technology.
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FDA Approves First Therapeutic Cancer Vaccine
Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.
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Lee, Charlotte Tsz-Sum; Doran, Diane Marie
2017-06-01
Patient safety is compromised by medical errors and adverse events related to miscommunications among healthcare providers. Communication among healthcare providers is affected by human factors, such as interpersonal relations. Yet, discussions of interpersonal relations and communication are lacking in healthcare team literature. This paper proposes a theoretical framework that explains how interpersonal relations among healthcare team members affect communication and team performance, such as patient safety. We synthesized studies from health and social science disciplines to construct a theoretical framework that explicates the links among these constructs. From our synthesis, we identified two relevant theories: framework on interpersonal processes based on social relation model and the theory of relational coordination. The former involves three steps: perception, evaluation, and feedback; and the latter captures relational communicative behavior. We propose that manifestations of provider relations are embedded in the third step of the framework on interpersonal processes: feedback. Thus, varying team-member relationships lead to varying collaborative behavior, which affects patient-safety outcomes via a change in team communication. The proposed framework offers new perspectives for understanding how workplace relations affect healthcare team performance. The framework can be used by nurses, administrators, and educators to improve patient safety, team communication, or to resolve conflicts.
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Transforming communication and safety culture in intrapartum care: a multi-organization blueprint.
Lyndon, Audrey; Johnson, M Christina; Bingham, Debra; Napolitano, Peter G; Joseph, Gerald; Maxfield, David G; O'Keeffe, Daniel F
2015-01-01
Effective, patient-centered communication facilitates interception and correction of potentially harmful conditions and errors. All team members, including women, their families, physicians, midwives, nurses, and support staff, have roles in identifying the potential for harm during labor and birth. However, the results of collaborative research studies conducted by organizations that represent professionals who care for women during labor and birth indicate that health care providers may frequently witness, but may not always report, problems with safety or clinical performance. Some of these health care providers felt resigned to the continuation of such problems and fearful of retribution if they tried to address them. Speaking up to address safety and quality concerns is a dynamic social process. Every team member must feel empowered to speak up about concerns without fear of put-downs, retribution, or receiving poor-quality care. Patient safety requires mutual accountability: individuals, teams, health care facilities, and professional associations have a shared responsibility for creating and sustaining environments of mutual respect and engaging in highly reliable perinatal care. Defects in human factors, communication, and leadership have been the leading contributors to sentinel events in perinatal care for more than a decade. Organizational commitment and executive leadership are essential to creating an environment that proactively supports safety and quality. The problem is well-known; the time for action is now. © 2015 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.
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DEFF Research Database (Denmark)
Karsdal, M A; Henriksen, K; Leeming, D J
2009-01-01
The aim of this review is to discuss the potential usefulness of a novel class of biochemical markers, neoepitopes, in the context of the US Food and Drug Administration (FDA) Critical Path Initiative, which emphasizes biomarkers of safety and efficacy as areas of pivotal interest. Examples...
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Environmental assessments and findings of no significant impact--FDA. Notice.
1998-05-18
The Food and Drug Administration (FDA) is announcing that it has reviewed environmental assessments (EA's) and issued findings of no significant impact (FONSI's) relating to the 167 new drug applications (NDA's) and supplemental applications listed in this document. FDA is publishing this notice because Federal regulations require public notice of the availability of environmental documents.
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21 CFR 516.34 - FDA recognition of exclusive marketing rights.
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive...
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Key Problems of Fire Safety Enforcement in Traffic and Communication Centers (TCC)
Medyanik, M.; Zosimova, O.
2017-10-01
A Traffic and Communication Center (TCC) means facilities designed and used to distribute and redirect flows of humans and motor vehicles while they get serviced and operate. This paper sets forth the basic problems of fire safety enforcement on the TCC, and the causes that slow down human and vehicle traffic speeds. It proposes ways to solve the problems of fire safety enforcement on the TCC, in the Russian Federation and elsewhere. Engineering solutions are proposed for TCC design, with key outlooks of TCC future development as an alternative way to organize access in transportation.
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Ziaei, Zainab; Hassell, Karen; Schafheutle, Ellen I
2015-01-01
According to Great Britain (GB)'s pharmacy regulator's standards of conduct, ethics and performance, pharmacists have a responsibility to ensure that they have sufficient linguistic skills to communicate and perform their job safely. Yet, very little is known about internationally trained pharmacists' (ITPs) linguistic proficiency. The purpose of this study was to investigate ITPs' perceptions of their communication proficiency and the resultant impact on patient safety. Eight focus groups were conducted between May and July 2010, with 31 European Economic Area (EEA) and 11 non-EEA pharmacists who, at the time of the study, practiced in community pharmacy (n = 29) or hospital (n = 13), in London, Manchester, Liverpool and Glasgow. The framework method was used to analyze qualitative data, and the Model of Communicative Proficiency (MCP) served as a framework to handle and explain the data obtained. ITPs experienced communication difficulties through new dialects, use of idioms and colloquial language in their workplace. The differences between the "BBC English" they learned formally and the "Street English" used in GB also led to difficulties. Culture was also recognized as an important aspect of communication. ITPs in this study were adamant that communication difficulty did not compromise patient safety. Communicative deficiency of ITPs arose primarily from two sources: linguistic competence and socio-cultural competence. These deficiencies could have negative implications for patient safety. The findings of this study should be taken into account when designing adaptation programs for ITPs. Copyright © 2015 Elsevier Inc. All rights reserved.
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Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations
Xu, Liren; Zhang, Chen; Rungta, Meha; Qiu, Wulin; Liu, Junqiang; Koros, William J.
2014-01-01
This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family
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Kim, Hyosun
2015-08-25
For the purpose of understanding the Food and Drug Administration's (FDA's) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers. The FDA's warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed. Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media promotions of
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Gas separation performance of 6FDA-based polyimides with different chemical structures
Qiu, Wulin
2013-10-01
This work reports the gas separation performance of several 6FDA-based polyimides with different chemical structures, to correlate chemical structure with gas transport properties with a special focus on CO2 and CH 4 transport and plasticization stability of the polyimides membranes relevant to natural gas purification. The consideration of the other gases (He, O2 and N2) provided additional insights regarding effects of backbone structure on detailed penetrant properties. The polyimides studied include 6FDA-DAM, 6FDA-mPDA, 6FDA-DABA, 6FDA-DAM:DABA (3:2), 6FDA-DAM:mPDA (3:2) and 6FDA-mPDA:DABA (3:2). Both pure and binary gas permeation were investigated. The packing density, which is tunable by adjusting monomer type and composition of the various samples, correlated with transport permeability and selectivity. The separation performance of the polyimides for various gas pairs were also plotted for comparison to the upper bound curves, and it was found that this family of materials shows attractive performance. The CO 2 plasticization responses for the un-cross-linked polyimides showed good plasticization resistance to CO2/CH4 mixed gas with 10% CO2; however, only the cross-linked polyimides showed good plasticization resistance under aggressive gas feed conditions (CO 2/CH4 mixed gas with 50% CO2 or pure CO 2). For future work, asymmetric hollow fibers and carbon molecular sieve membranes based on the most attractive members of the family will be considered. © 2013 Elsevier Ltd. All rights reserved.
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Investigating drug repositioning opportunities in FDA drug labels through topic modeling.
Bisgin, Halil; Liu, Zhichao; Kelly, Reagan; Fang, Hong; Xu, Xiaowei; Tong, Weida
2012-01-01
Drug repositioning offers an opportunity to revitalize the slowing drug discovery pipeline by finding new uses for currently existing drugs. Our hypothesis is that drugs sharing similar side effect profiles are likely to be effective for the same disease, and thus repositioning opportunities can be identified by finding drug pairs with similar side effects documented in U.S. Food and Drug Administration (FDA) approved drug labels. The safety information in the drug labels is usually obtained in the clinical trial and augmented with the observations in the post-market use of the drug. Therefore, our drug repositioning approach can take the advantage of more comprehensive safety information comparing with conventional de novo approach. A probabilistic topic model was constructed based on the terms in the Medical Dictionary for Regulatory Activities (MedDRA) that appeared in the Boxed Warning, Warnings and Precautions, and Adverse Reactions sections of the labels of 870 drugs. Fifty-two unique topics, each containing a set of terms, were identified by using topic modeling. The resulting probabilistic topic associations were used to measure the distance (similarity) between drugs. The success of the proposed model was evaluated by comparing a drug and its nearest neighbor (i.e., a drug pair) for common indications found in the Indications and Usage Section of the drug labels. Given a drug with more than three indications, the model yielded a 75% recall, meaning 75% of drug pairs shared one or more common indications. This is significantly higher than the 22% recall rate achieved by random selection. Additionally, the recall rate grows rapidly as the number of drug indications increases and reaches 84% for drugs with 11 indications. The analysis also demonstrated that 65 drugs with a Boxed Warning, which indicates significant risk of serious and possibly life-threatening adverse effects, might be replaced with safer alternatives that do not have a Boxed Warning. In
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Pancreatic Safety of Incretin-Based Drugs - FDA and EMA Assessment
Egan, Amy G.; Blind, Eberhard; Dunder, Kristina; de Graeff, Pieter A.; Hummer, B. Timothy; Bourcier, Todd; Rosebraugh, Curtis
2014-01-01
After evaluating a safety signal regarding pancreatitis and pancreatic cancer in patients using incretin-based drugs, the Food and Drug Administration and the European Medicines Agency conclude that assertions of a causal association are inconsistent with the data. With approximately 25.8 million
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Directory of Open Access Journals (Sweden)
Akram Ghahramanian
2017-06-01
Full Text Available Background: This study investigated quality of healthcare services from patients’ perspectives and its relationship with patient safety culture and nurse-physician professional communication. Methods: A cross-sectional study was conducted among 300 surgery patients and 101 nurses caring them in a public hospital in Tabriz–Iran. Data were collected using the service quality measurement scale (SERVQUAL, hospital survey on patient safety culture (HSOPSC and nurse physician professional communication questionnaire. Results: The highest and lowest mean (±SD scores of the patients’ perception on the healthcare services quality belonged to the assurance 13.92 (±3.55 and empathy 6.78 (±1.88 domains,respectively. With regard to the patient safety culture, the mean percentage of positive answers ranged from 45.87% for "non-punitive response to errors" to 68.21% for "organizational continuous learning" domains. The highest and lowest mean (±SD scores for the nurse physician professional communication were obtained for "cooperation" 3.44 (±0.35 and "non participative decision-making" 2.84 (±0.34 domains, respectively. The "frequency of reported errors by healthcare professionals" (B=-4.20, 95% CI = -7.14 to -1.27, P<0.01 and "respect and sharing of information" (B=7.69, 95% CI=4.01 to 11.36, P<0.001 predicted the patients’perceptions of the quality of healthcare services. Conclusion: Organizational culture in dealing with medical error should be changed to non punitive response. Change in safety culture towards reporting of errors, effective communication and teamwork between healthcare professionals are recommended.
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Ghahramanian, Akram; Rezaei, Tayyebeh; Abdullahzadeh, Farahnaz; Sheikhalipour, Zahra; Dianat, Iman
2017-01-01
Background: This study investigated quality of healthcare services from patients' perspectives and its relationship with patient safety culture and nurse-physician professional communication. Methods: A cross-sectional study was conducted among 300 surgery patients and 101 nurses caring them in a public hospital in Tabriz-Iran. Data were collected using the service quality measurement scale (SERVQUAL), hospital survey on patient safety culture (HSOPSC) and nurse physician professional communication questionnaire. Results: The highest and lowest mean (±SD) scores of the patients' perception on the healthcare services quality belonged to the assurance 13.92 (±3.55) and empathy 6.78 (±1.88) domains,respectively. With regard to the patient safety culture, the mean percentage of positive answers ranged from 45.87% for "non-punitive response to errors" to 68.21% for "organizational continuous learning" domains. The highest and lowest mean (±SD) scores for the nurse physician professional communication were obtained for "cooperation" 3.44 (±0.35) and "non-participative decision-making" 2.84 (±0.34) domains, respectively. The "frequency of reported errors by healthcare professionals" (B=-4.20, 95% CI = -7.14 to -1.27, P<0.01) and "respect and sharing of information" (B=7.69, 95% CI=4.01 to 11.36, P<0.001) predicted the patients'perceptions of the quality of healthcare services. Conclusion: Organizational culture in dealing with medical error should be changed to non-punitive response. Change in safety culture towards reporting of errors, effective communication and teamwork between healthcare professionals are recommended.
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Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations
Xu, Liren
2014-06-01
This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family with attractive dense film properties for several potential applications. The work reported here for the 6FDA-DAM polyimide provides insight for the challenging fabrication of defect-free asymmetric hollow fiber membranes for this class of 6FDA-polyimides, which behave rather different from lower free volume polymers. Specifically, the 6FDA based materials show relatively slow phase separation rate in water quench baths, which presents a challenge for fiber spinning. For convenience, we refer to the behavior as more "non-solvent resistant" in comparison to other lower free volume polymers, since the binodal phase boundary is displaced further from the conventional position near the pure polymer-solvent axis on a ternary phase diagram in conventional polymers like Matrimid® and Ultem®. The addition of lithium nitrate to promote phase separation has a useful impact on 6FDA-DAM asymmetric hollow fiber formation. 6FDA-DAM phase diagrams using ethanol and water as non-solvent are reported, and it was found that water is less desirable as a non-solvent dope additive for defect-free fiber spinning. Phase diagrams are also reported for 6FDA-DAM dope formulation with and without the addition of lithium nitrate, and defect-free asymmetric hollow fiber membranes are reported for both cases. The effect of polymer molecular weight on defect-free fiber spinning was also investigated. Gas transport properties and morphology of hollow fibers were characterized. With several thorough case studies, this work provides a systematic guideline for defect-free fiber formation from 6FDA-polymers. © 2014 Elsevier B.V.
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Tjia, Jennifer; Mazor, Kathleen M; Field, Terry; Meterko, Vanessa; Spenard, Ann; Gurwitz, Jerry H
2009-09-01
Clear and complete communication between health care providers is a prerequisite for safe patient management and is a major priority of the Joint Commission's 2008 National Patient Safety Goals. The goal of this study was to describe nurses' perceptions of nurse-physician communication in the long-term care (LTC) setting. Mixed-method study including a self-administered questionnaire and qualitative semistructured telephone interviews of licensed nurses from 26 LTC facilities in Connecticut. The questionnaire measured perceived openness to communication, mutual understanding, language comprehension, frustration, professional respect, nurse preparedness, time burden, and logistical barriers. Qualitative interviews focused on identifying barriers to effective nurse-physician communication that may not have previously been considered and eliciting nurses' recommendations for overcoming those barriers. Three hundred seventy-five nurses completed the questionnaire, and 21 nurses completed qualitative interviews. Nurses identified several barriers to effective nurse-physician communication: lack of physician openness to communication, logistic challenges, lack of professionalism, and language barriers. Feeling hurried by the physician was the most frequent barrier (28%), followed by finding a quiet place to call (25%), and difficulty reaching the physician (21%). In qualitative interviews, there was consensus that nurses needed to be brief and prepared with relevant clinical information when communicating with physicians and that physicians needed to be more open to listening. A combination of nurse and physician behaviors contributes to ineffective communication in the LTC setting. These findings have important implications for patient safety and support the development of structured communication interventions to improve quality of nurse-physician communication.
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Schwappach, David L B; Meyer Massetti, Carla; Gehring, Katrin
2012-10-01
Foreign-language (FL) patients are at increased risk for adverse drug events. Evidence regarding communication barriers and the safety of pharmaceutical care of FL patients in European countries is scarce despite large migrant populations. To investigate Swiss public pharmacists' experiences and current practices in counselling FL patients with a focus on patient safety. In a cross-sectional study heads of public pharmacies in Switzerland were surveyed using an electronic questionnaire. The survey assessed the frequency of communication barriers encountered in medication counselling of FL patients, perceptions of risks for adverse drug events, satisfaction with the quality of counselling provided to FL patients, current strategies to reduce risks, and preferences towards tools to improve safety for FL patients. 498 pharmacists completed the survey (43 % response rate). More than every second pharmacist reported at least weekly encounters at which they cannot provide good medication counselling to FL patients in the regional Swiss language. Ad-hoc interpreting by minors is also common at a considerable number of pharmacies (26.5 % reported at least one weekly occurrence). Approximately 10 % of pharmacies reported that they fail at least weekly to explain the essentials of drug therapy (e.g. dosing of children's medications) to FL patients. 79.8 % perceived the risk of FL patients for adverse drug events to be somewhat or much higher compared to other patients. 22.5 % of pharmacists reported being concerned at least monthly about medication safety when FL patients leave their pharmacy. However, the majority of pharmacists were satisfied with the quality of care provided to FL patients in their pharmacy [78.6 % (very) satisfied]. The main strategy used to improve counselling for FL patients was the employment of multilingual staff. Participants would use software for printing foreign-language labels (41.2 %) and multilingual package inserts (42.0 %) if these were
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Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.
KuKanich, Butch; Warner, Matt; Hahn, Kevin
2017-02-01
OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.
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Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
Yu, Lawrence X; Baker, Jeffrey; Berlam, Susan C; Boam, Ashley; Brandreth, E J; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M V; Mullin, Theresa; Raju, G K; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar
2015-07-01
On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.
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FDA-approved small-molecule kinase inhibitors
DEFF Research Database (Denmark)
Wu, Peng; Nielsen, Thomas E.; Clausen, Mads Hartvig
2015-01-01
Kinases have emerged as one of the most intensivelypursued targets in current pharmacological research,especially for cancer, due to their critical roles in cellularsignaling. To date, the US FDA has approved 28 smallmoleculekinase inhibitors, half of which were approvedin the past 3 years. While...
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Underhill, Kristen; Morrow, Kathleen M; Operario, Don; Mayer, Kenneth H
2014-02-01
The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while others perceived approval as irrelevant or less significant than other sources of information. Our results suggest that FDA approval sends a signal that directly shapes PrEP acceptability among some MSM, while indirect influences of approval may affect uptake by others. Efforts to educate MSM about PrEP can increase acceptability by incorporating information about FDA approval, and outreach strategies should consider how this information may factor into personal decisions about PrEP use.
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2010-09-15
... FDA to meet the White House Food Safety Working Group recommendation that the Federal government... development of an integrated food safety system, and the development and implementation of a sustainable model... levels. NCFPD also has past experience directly supporting the White House Food Safety Working Group...
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Wood, Lauren N; Jamnagerwalla, Juzar; Markowitz, Melissa A; Thum, D Joseph; McCarty, Philip; Medendorp, Andrew R; Raz, Shlomo; Kim, Ja-Hong
2018-04-26
Uterine power morcellation, where the uterus is shred into smaller pieces, is a widely used technique for removal of uterine specimens in patients undergoing minimally invasive abdominal hysterectomy or myomectomy. Complications related to power morcellation of uterine specimens led to US Food and Drug Administration (FDA) communications in 2014 ultimately recommending against the use of power morcellation for women undergoing minimally invasive hysterectomy. Subsequently, practitioners drastically decreased the use of morcellation. We aimed to determine the effect of increased patient awareness on the decrease in use of the morcellator. Google Trends is a public tool that provides data on temporal patterns of search terms, and we correlated this data with the timing of the FDA communication. Weekly relative search volume (RSV) was obtained from Google Trends using the term “morcellation.” Higher RSV corresponds to increases in weekly search volume. Search volumes were divided into 3 groups: the 2 years prior to the FDA communication, a 1-year period following, and thereafter, with the distribution of the weekly RSV over the 3 periods tested using 1-way analysis of variance. Additionally, we analyzed the total number of websites containing the term “morcellation” over this time. The mean RSV prior to the FDA communication was 12.0 (SD 15.8), with the RSV being 60.3 (SD 24.7) in the 1-year after and 19.3 (SD 5.2) thereafter (PGoogle search activity about morcellation of uterine specimens increased significantly after the FDA communications. This trend indicates an increased public awareness regarding morcellation and its complications. More extensive preoperative counseling and alteration of surgical technique and clinician practice may be necessary. ©Lauren N Wood, Juzar Jamnagerwalla, Melissa A Markowitz, D Joseph Thum, Philip McCarty, Andrew R Medendorp, Shlomo Raz, Ja-Hong Kim. Originally published in JMIR Public Health and Surveillance (http
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Evaluating eating behavior treatments by FDA standards
Directory of Open Access Journals (Sweden)
A. Janet eTomiyama
2014-01-01
Full Text Available Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require the patients’ time and investment, and may have risks. The Food and Drug Administration (FDA has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1 Is the treatment safe? (2 How dangerous is the condition the intervention is treating? (3 Is the treatment effective? (4 Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine.
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Comprehension of hazard communication: effects of pictograms on safety data sheets and labels.
Boelhouwer, Eric; Davis, Jerry; Franco-Watkins, Ana; Dorris, Nathan; Lungu, Claudiu
2013-09-01
The United Nations has proposed the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals to make hazard communication more uniform and to improve comprehension. Two experiments were conducted to test whether the addition of hazard and precautionary pictograms to safety data sheets and product labels would improve the transfer of information to users compared to safety data sheets and product labels containing text only. Additionally, naïve users, workers, and experts were tested to determine any potential differences among users. The effect of adding pictograms to safety data sheets and labels was statistically significant for some conditions, but was not significant across all conditions. One benefit of the addition of pictograms was that the time to respond to the survey questions decreased when the pictograms were present for both the SDS and the labels. GHS format SDS and labels do provide benefits to users, but the system will need further enhancements and modifications to continue to improve the effectiveness of hazard communication. The final rule to modify the HCS to include the Globally Harmonized System (GHS) for the Classification and Labelling of Chemicals announced by OSHA (2012b) will change the information content of every chemical SDS and label used in commerce. This study suggests that the inclusion of GHS hazard pictograms and precautionary pictograms to SDS and labels may benefit the user. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.
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International Nuclear Information System (INIS)
Preckshot, G.G.
1993-08-01
The purpose of this paper is to recommend regulatory guidance for reviewers examining computer communication systems used in nuclear power plants. The recommendations cover three areas important to these communications systems: system design, communication protocols, and communication media. The first area, system design, considers three aspects of system design--questions about architecture, specific risky design elements or omissions to look for in designs being reviewed, and recommendations for multiplexed data communication systems used in safety systems. The second area reviews pertinent aspects of communication protocol design and makes recommendations for newly designed protocols or the selection of existing protocols for safety system, information display, and non-safety control system use. The third area covers communication media selection, which differs significantly from traditional wire and cable. The recommendations for communication media extend or enhance the concerns of published IEEE standards about three subjects: data rate, imported hazards and maintainability
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Gupta, Ravi; Dhruva, Sanket S; Fox, Erin R; Ross, Joseph S
2017-10-01
Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. To examine the clinical evidence for approval and association with prices and shortages of previously unapproved prescription drugs after being addressed by the UDI. Previously unapproved prescription drugs that faced UDI regulatory action or with at least 1 product that received FDA approval through manufacturers' voluntary compliance with the UDI between 2006 and 2015 were identified. The clinical evidence was categorized as either newly conducted clinical trials or use of previously published literature and/or bioequivalence studies to demonstrate safety and efficacy. We determined the change in average wholesale price, presence of shortage, and duration of shortage for each drug during the 2 years before and after UDI regulatory action or approval through voluntary compliance. Between 2006 and 2015, 34 previously unapproved prescription drugs were addressed by the UDI. Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. Among the 26 drugs with available pricing data, average wholesale price during the 2 years before and after voluntary approval or UDI action increased by a median of 37% (interquartile range [IQR] = 23%-204%; P Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to
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2011-05-24
... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...
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Communicating food safety, authenticity and consumer choice. Field experiences.
Syntesa, Heiner Lehr
2013-04-01
The paper reviews patented and non-patented technologies, methods and solutions in the area of food traceability. It pays special attention to the communication of food safety, authenticity and consumer choice. Twenty eight recent patents are reviewed in the areas of (secure) identification, product freshness indicators, meat traceability, (secure) transport of information along the supply chain, country/region/place of origin, automated authentication, supply chain management systems, consumer interaction systems. In addition, solutions and pilot projects are described in the areas of Halal traceability, traceability of bird's nests, cold chain management, general food traceability and other areas.
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A History of the Sonocare CST-100: The First FDA-approved HIFU Device
Muratore, Robert
2006-05-01
The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.
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2012-08-06
...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... per year. B. Research Objectives The goal of FDA's OPD grant program is to support the clinical... (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of...
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New FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis.
English, Clayton; Aloi, Joseph J
2015-04-01
Interferon injectables and glatiramer acetate have served as the primary disease-modifying treatments for multiple sclerosis (MS) since their introduction in the 1990s and are first-line treatments for relapsing-remitting forms of MS (RRMS). Many new drug therapies were launched since early 2010, expanding the drug treatment options considerably in a disease state that once had a limited treatment portfolio. The purpose of this review is to critically evaluate the safety profile and efficacy data of disease-modifying agents for MS approved by the US Food and Drug Administration (FDA) from 2010 to the present and provide cost and available pharmacoeconomic data about each new treatment. Peer-reviewed clinical trials, pharmacoeconomic studies, and relevant pharmacokinetic/pharmacologic studies were identified from MEDLINE (January 2000-December 2014) by using the search terms multiple sclerosis, fingolimod, teriflunomide, alemtuzumab, dimethyl fumarate, pegylated interferon, peginterferon beta-1a, glatiramer 3 times weekly, and pharmacoeconomics. Citations from available articles were also reviewed for additional references. The databases publically available at www.clinicaltrials.gov and www.fda.gov were searched for unpublished studies or studies currently in progress. A total of 5 new agents and 1 new dosage formulation were approved by the FDA for the treatment of RRMS since 2010. Peginterferon beta-1a and high-dose glatiramer acetate represent 2 new effective injectable options for MS that reduce burden of administration seen with traditional interferon and low-dose glatiramer acetate. Fingolimod, teriflunomide, and dimethyl fumarate represent new oral agents available for MS, and their efficacy in reducing annualized relapse rates is 48% to 55%, 22% to 36.3%, and 44% to 53%, respectively, compared with placebo. Alemtuzumab is a biologic given over a 2-year span that reduced annualized relapse rates by 55% in treatment-naive patients and by 49% in patients
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75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2010-05-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...
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Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.
Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark
2017-06-01
An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post
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Text messaging for sexual communication and safety among African American young adults.
Broaddus, Michelle R; Dickson-Gomez, Julia
2013-10-01
African American young adults are at high risk of HIV infection during their lifetimes, and the male condom remains the best method of prevention. Efforts to increase condom use should address the barrier of condom negotiation. We conducted a thematic analysis of qualitative, semistructured interviews with African American young adults to examine their use of text messaging for requesting human immunodeficiency virus (HIV) or sexually transmitted infection (STI) testing and condom use within the larger context of general sexual communication using text messages. Text messaging gave participants a level of comfort and disinhibition to discuss sexual topics and negotiate sexual safety. Benefits of text messages included ease of communication, privacy, and increased ability to express condom desires. Difficulties reflected the potential relationship implications of suggesting HIV/STI testing and condom use. Condom negotiation strategies using text messages also mirrored those found to be used in face-to-face communication.
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Vanderbilt, Allison A; Pappada, Scott M; Stein, Howard; Harper, David; Papadimos, Thomas J
2017-01-01
Hospitals have struggled for years regarding the handoff process of communicating patient information from one health care professional to another. Ineffective handoff communication is recognized as a serious patient safety risk within the health care community. It is essential to take communication into consideration when examining the safety of neonates who require immediate medical attention after birth; effective communication is vital for positive patient outcomes, especially with neonates in a delivery room setting. Teamwork and effective communication across the health care continuum are essential for providing efficient, quality care that leads to favorable patient outcomes. Interprofessional simulation and team training can benefit health care professionals by improving interprofessional competence, defined as one's knowledge of other professionals including an understanding of their training and skillsets, and role clarity. Interprofessional teams that include members with specialization in obstetrics, gynecology, and neonatology have the potential to considerably benefit from training effective handoff and communication practices that would ensure the safety of the neonate upon birth. We must strive to provide the most comprehensive systematic, standardized, interprofessional handoff communication training sessions for such teams, through Graduate Medical Education and Continuing Medical Education that will meet the needs across the educational continuum.
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International Nuclear Information System (INIS)
Thuy, N. N. Q.
2006-01-01
Inappropriately designed inter-channel and inter-system digital communications could initiate common cause failure of multiple channels or multiple systems. Defensive measures were introduced in EPRI report TR-1002835 (Guideline for Performing Defense-in-Depth and Diversity Assessments for Digital Upgrades) to assess, on a deterministic basis, the susceptibility of digital systems architectures to common-cause failures. This paper suggests how this approach could be applied to assess inter-channel and inter-system digital communications from a safety standpoint. The first step of the approach is to systematically identify the so called 'influence factors' that one end of the data communication path can have on the other. Potential factors to be considered would typically include data values, data volumes and data rates. The second step of the approach is to characterize the ways possible failures of a given end of the communication path could affect these influence factors (e.g., incorrect data values, excessive data rates, time-outs, incorrect data volumes). The third step is to analyze the designed-in measures taken to guarantee independence of the other end. In addition to classical error detection and correction codes, typical defensive measures are one-way data communication, fixed-rate data communication, fixed-volume data communication, validation of data values. (authors)
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2011-02-16
... evaluation of the food safety of their new plant variety. Such communication will help to ensure that any... documentation and communication regarding the bioengineered plant. For example, FDA typically places information... Plant Varieties AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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2011-03-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0135..., to request onsite parking, or to submit the full text, comprehensive outline, or summary of an oral presentation: Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administation, 5100...
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International Nuclear Information System (INIS)
Kim, Jung-hun; Kim, Dong-hoon; Lee, Dong-young; Park, Sung-woo
2006-01-01
The communication protocol in nuclear power plants needs to be validated systematically to avoid the critical situation that may be caused by its own faults. We establish the methodology to validate the protocol designed for the Integrated Safety Communication Networks (ISCN) of Korea Nuclear Instrumentation and Control System (KNICS). The ISCN protocol is specified using the formal description technique called the SDL. The validation of ISCN protocol is done via the Simulator and Validator, both of which are main functions provided by the SDL
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2010-12-08
... significant number of Council members have made business and travel plans in accordance with this schedule... implementation of solutions and best practices for public safety communications and cybersecurity. Recognizing... Public Notice announcing the meeting is available at http://www.fcc.gov/Daily_Releases/Daily_Business...
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FDA regulations for commercial food irradiation
International Nuclear Information System (INIS)
Takeguchi, C.A.
1985-01-01
The Food and Drug Administration published an Advance Notice of Proposed Rulemaking (ANPR) on food irradiation on March 27, 1981 (FDA, 1981). The next step in the rulemaking process is a proposed rule that will deal with low-dose irradiation of certain foods and high-dose irradiation of spices. The status of the proposed regulation is discussed
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Communication practices in engineering, manufacturing, and research for food and water safety
2015-01-01
This book demonstrates some of the ways in which communication and developing technologies can improve global food and water safety by providing a historical background on outbreaks and public resistance, as well as generating interest in youth and potential professionals in the field : History of muckraking in the food industry ; Case study on groundwater regulation ; Interviews with members of the beef industry and livestock market owners.
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FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology.
Grant, Evita V
Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.
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2010-07-02
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2010-M-0068...
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2013-06-12
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...
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2011-06-02
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...
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Small-molecule kinase inhibitors: an analysis of FDA-approved drugs
DEFF Research Database (Denmark)
Wu, Peng; Nielsen, Thomas Eiland; Clausen, Mads Hartvig
2016-01-01
Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther......Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function...
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FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.
Wilson, Carolyn A; Simonyan, Vahan
2014-01-01
Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and
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Chee, Brant Wah Kwong
2011-01-01
This dissertation explores the use of personal health messages collected from online message forums to predict drug safety using natural language processing and machine learning techniques. Drug safety is defined as any drug with an active safety alert from the US Food and Drug Administration (FDA). It is believed that this is the first…
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Modem Communications Systems Development Guidelines in Function of Air Traffic Safety ...
Directory of Open Access Journals (Sweden)
Petar Obradović
2007-05-01
Full Text Available The communications requirements in air traffic control areincreasing in complexity. From the middle 90s, huge progress inairport infrastructure, especially in air traffic control systems,has been made in Bosnia and Herzegovina in damage rehabilitation,caused by war conflicts, owing, first of all, to the EuropeanUnion aid that contributed to the re-establishment of regularinternational air traffic. The current air traffic control systemhas matured in its functionality. Therefore, the phase of advancementand preparation for the technological improvementis the next logical step. However, before establishing a new communicationsstrategy, the current application trends have to beanalyzed in details according to the existing communicationsenvironment interfaces. The goal of this work is to find theguidelines of technological development that will result in moreefficiency, safety and economic benefit in the near future, butthe air traffic safety must not be compromised by economicbenefit.
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FDA publishes checklist of Y2K high-risk devices.
1999-09-01
Key points. The federal Food and Drug Administration (FDA) has developed a list of types of medical devices that have the potential for the most serious consequences for patients should they fail because of Y2K-related problems. This list of computer-controlled potentially high-risk devices can provide a guide to health care facilities regarding the types of devices that should receive priority in their assessment and remediation of medical devices. The list may change as the FDA receives comments on the types of devices included in the list.
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2013-08-19
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0462...
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2010-06-24
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug...; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-M-0317...
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High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations
Zhang, Chen; Dai, Ying; Johnson, Justin R.; Karvan, Oguz; Koros, William J.
2012-01-01
We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.
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High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations
Zhang, Chen
2012-02-01
We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.
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International Nuclear Information System (INIS)
Matsumoto, Takanobu; Shiomi, Tetsuro
2004-01-01
Effectiveness of risk communication were previously discussed through both ''risk information'' and ''benefit information'' of its topics. However, in technical facilities facilities such as nuclear power plant where safeness is an important concern, not only these two aspects but also safety-measures information'' are required. There have been previously no such discussions about risk communication that included ''safety-measures information''. In this report, we investigated general public's view of the difference in effectiveness of risk communication between two cases. In the first case, only ''risk'' and ''benefit information'' were given. In the second case, we added ''safety-measures information'' as well as ''risk'' and benefit information''. Measurement of the effect was performed using a questionnaire. We divided the subjects into two groups. Each group was shown one side of two pamphlets which had information concerning two conditions, and asked how it feels about ''reliance on information'', ''reliance on informer'', ''posture considered with informer'' which are factors in the process of the attitude change that is shown in the paradigm of risk communication (Kinoshita and Kikkawa, (1990)). Prior to this investigation, we identified each subject is position on nuclear power generation. Thus we were able to clarify the effectiveness of each risk communication style depending on each subject is position (approval, neutrality, objection). As a result, we reached the following conclusions: First about ''reliance on information'', where asked whether the contents of a pamphlet would be reliable, it was found that the person negative to nuclear power generation evaluated lower the pamphlet which included ''safety-measures information'' than the other. However, it was found that regardless of the difference in the position towards nuclear power generation, people who read the pamphlet including ''safety-measures information'' evaluated higher ''reliance on
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Energy Technology Data Exchange (ETDEWEB)
Miller, W.M.; Hooker, P.J. [ENVIROS Consulting ltd, 61, the Shore Leith, UK-0 EH6 6RA Edinburgh (United Kingdom)
2004-07-01
Analogue information can increase our conceptual understanding of long-term repository behaviour in support of post-closure performance assessment (PA), provide quantitative data for PA models and provide ways of communicating safety information to non-specialist audiences. These functions of analogue studies have, however, received too little attention in PA reports and safety cases. Many analogue studies have been undertaken in the last two decades costing tens of millions of euros, and these have covered a wide range of phenomena such as uranium ore deposition, natural fission reactors, natural nuclide migration, contaminant containment by clays and sediments, preservation of ancient fossil trees and buried artefacts etc. The different uses of analogues would be easier to manage if a single database of quality approved analogue information were to be created. NAnet, a Thematic Network within the 5. EURATOM FP is aiming to promote more considered applications of analogues in performance and safety assessments and in audience dialogue. NAnet intends critically to review a number of analogue studies in terms of their relevance and limitations to different repository concepts and environments and with regard to their applications in performance assessments, safety cases and communication. On the basis of these reviews, a simple digital database is being developed for the PA community which will allow PA modelers to make quicker and wider use of natural analogue information in performance and safety assessments. It is expected that some of these tools will help radioactive waste institutions to make better use of natural analogue information for communication with different audiences, including the public. (authors)
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2012-07-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0603] Assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New... statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for...
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Free Space Optics Communication for Mobile Military Platforms
2003-12-01
Federal Communications Commission FDA Food and Drug Administration FOV Field-of-View FSO Free Space Optics FWHM Full Width at Half Maximum Gbps...Physique et de Métrologie des Oscillateurs (LPMO) du CNRS UPR3203, associé à l’Université de Franche -Comté, 15 March 2002 [Schenk 2000] H. Schenk
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Dose Matters: FDA's Guidance on Children's X-rays
... Consumer Updates Dose Matters: FDA's Guidance on Children's X-rays Share Tweet Linkedin Pin it More sharing options ... exposure during medical procedures. The level of ionizing radiation from X-ray imaging is generally very low, but can ...
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Directory of Open Access Journals (Sweden)
Vanderbilt AA
2017-06-01
Full Text Available Allison A Vanderbilt,1 Scott M Pappada,2 Howard Stein,3 David Harper,4 Thomas J Papadimos5 1Department of Family Medicine, 2Department of Anesthesiology, College of Medicine and Life Sciences, University of Toledo, 3Department of Pediatrics, ProMedica Toledo Children’s Hospital, 4Department of Obstetrics and Gynecology, ProMedica Toledo Hospital, 5Department of Anesthesiology, College of Medicine and the Life Sciences, University of Toledo, Toledo, OH, USA Abstract: Hospitals have struggled for years regarding the handoff process of communicating patient information from one health care professional to another. Ineffective handoff communication is recognized as a serious patient safety risk within the health care community. It is essential to take communication into consideration when examining the safety of neonates who require immediate medical attention after birth; effective communication is vital for positive patient outcomes, especially with neonates in a delivery room setting. Teamwork and effective communication across the health care continuum are essential for providing efficient, quality care that leads to favorable patient outcomes. Interprofessional simulation and team training can benefit health care professionals by improving interprofessional competence, defined as one’s knowledge of other professionals including an understanding of their training and skillsets, and role clarity. Interprofessional teams that include members with specialization in obstetrics, gynecology, and neonatology have the potential to considerably benefit from training effective handoff and communication practices that would ensure the safety of the neonate upon birth. We must strive to provide the most comprehensive systematic, standardized, interprofessional handoff communication training sessions for such teams, through Graduate Medical Education and Continuing Medical Education that will meet the needs across the educational continuum. Keywords
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Baker, Hannah M; Lee, Joseph G L; Ranney, Leah M; Goldstein, Adam O
2016-02-01
Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. All 50 states and the District of Columbia. Tobacco retailer inspections conducted by FDA (n = 33 543). State cigarette tax, youth smoking prevalence, poverty, and tobacco production. State proportion of FDA warning letters issued for single cigarette violations. There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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47 CFR 80.1127 - On-scene communications.
2010-10-01
....1127 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Operating Procedures for Distress and Safety Communications § 80.1127 On-scene communications. (a) On-scene communications...
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Chambers, James D; May, Katherine E; Neumann, Peter J
2013-06-01
The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.
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Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.
Sarapa, Nenad
2007-09-01
The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.
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2011-10-14
...] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and... Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management... Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1...
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Official communication of the Safety Commission
DG Unit
2009-01-01
The Prevention and Training section of the Safety Commission, would like to inform you that the new Safety Awareness course for newcomers will replace the welcome video in building 55 as of 2 April. The 3 levels (‘Safety at CERN’, ‘General Risks’ and ‘Specific Risks’) followed by 3 tests will determine access to CERN. Thanks to the SIR (Safety Information Registration, http://sir.cern.ch) application, it will be possible for you to follow the awareness course from your computer. For more information, go to the Safety Commission web site: http://safety-commission.web.cern.ch
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Official communication of the Safety Commission
DG Unit
2009-01-01
We, the Prevention and Training section of the Safety Commission, would like to inform you that the new Safety Awareness course for newcomers will replace the welcome video in building 55 as of the 2nd April. The 3 levels (‘Safety at CERN’, ‘General Risks’ and ‘Specific Risks’) followed by 3 tests will determine access to CERN. Thanks to the SIR (Safety Information Registration, http://sir.cern.ch) application, it will be possible for you to follow the awareness course from your computer. For more information, go to the Safety Commission web site: http://safety-commission.web.cern.ch
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Miller, Jennifer E; Korn, David; Ross, Joseph S
2015-01-01
Objective To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Main outcome measures Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level. Results The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32–83%) of trials were registered, 20% (IQR 12–28%) reported results in ClinicalTrials.gov, 56% (IQR 41–83%) were published, and 65% (IQR 41–83%) were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed phase II or III trial. Per drug, a median of 17% (IQR 8–20%) of trials supporting FDA approvals were subject to FDAAA mandated public disclosure; of these, a median of 67% (IQR 0–100%) were FDAAA-compliant. 68% of research participants (67 629 of 99 599) participated in FDAAA-subject trials, with 51% (33 405 of 67 629) enrolled in non-compliant trials. Transparency varied widely among companies. Conclusions Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve
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Underhill, Kristen; Morrow, Kathleen M.; Operario, Don; Mayer, Kenneth H.
2014-01-01
The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while o...
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Directory of Open Access Journals (Sweden)
Chatterjee S
2012-12-01
Full Text Available Objective: To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA to pharmaceutical manufacturers for promotional violations.Methods: Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL, and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market.Results: In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6% followed by unsubstantiated efficacy claims (18.6%. Warning letters were primarily directed to manufacturers of cardiovascular (14.6%, anti-microbial (14.6%, and CNS (12.5% drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%. Conclusion: The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health.
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Development of the switch requirements and architecture of a safety data communication system
International Nuclear Information System (INIS)
Jeong, K.I.; Lee, J.K.; Park, H.Y.; Koo, I.S.
2004-12-01
In accordance with digitalising the Instrumentation and Control(I and C) systems in the integral reactor, a communication network is required for effective information exchanges between the different equipment, an enhancement of the design flexibility, a simple installation and cost reduction. Generally, a communication network consists of a topology, the protocol, a communication medium, an interconnection device, etc. In this report, the development methods of switch and the architecture of a Safety Data Communication System(SDCS) are investigated and analyzed. In this report, the design requirements for switch are presented, which are the essential requirements to develop the switch in a SDCS of the SMART-P. To establish these requirements, the evaluation and analysis of the design and implementation method of the COTS switches, the architecture of SDCS and the design requirements of a SDCS were performed. At the detail design stage, these requirements will be used for the top-tier requirements, especially the design target and design basis. To develop the detail design requirements in the future, more quantitative and qualitative analyses are required. In the case of selecting the COTS switch and developing the switch, these requirements will also be used for the evaluation guide
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Development of the switch requirements and architecture of a safety data communication system
Energy Technology Data Exchange (ETDEWEB)
Jeong, K.I.; Lee, J.K.; Park, H.Y.; Koo, I.S
2004-12-01
In accordance with digitalising the Instrumentation and Control(I and C) systems in the integral reactor, a communication network is required for effective information exchanges between the different equipment, an enhancement of the design flexibility, a simple installation and cost reduction. Generally, a communication network consists of a topology, the protocol, a communication medium, an interconnection device, etc. In this report, the development methods of switch and the architecture of a Safety Data Communication System(SDCS) are investigated and analyzed. In this report, the design requirements for switch are presented, which are the essential requirements to develop the switch in a SDCS of the SMART-P. To establish these requirements, the evaluation and analysis of the design and implementation method of the COTS switches, the architecture of SDCS and the design requirements of a SDCS were performed. At the detail design stage, these requirements will be used for the top-tier requirements, especially the design target and design basis. To develop the detail design requirements in the future, more quantitative and qualitative analyses are required. In the case of selecting the COTS switch and developing the switch, these requirements will also be used for the evaluation guide.
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Willis, Alexander R; Ippolito, Joseph A; Patterson, Francis R; Benevenia, Joseph; Beebe, Kathleen S
2016-01-01
Customizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Currently, obtaining customizable orthopaedic implants for orthopaedic oncology patients can be an arduous task involving submitting approval requests to the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). There is great potential for the delay of a patient's surgery and unnecessary paperwork if the submission pathways are misunderstood or a streamlined protocol is not in place. The objective of this study was to review the existing FDA custom implant approval pathways and to determine whether this process was improved with an institutional protocol. An institutional protocol for obtaining IRB and FDA approval for customizable orthopaedic implants was established with the IRB at our institution in 2013. This protocol was approved by the IRB, such that new patients only require submission of a modification to the existing protocol with individualized patient information. During the two-year period of 2013-2014, eight patients were retrospectively identified as having required customizable implants for various orthopaedic oncology surgeries. The dates of request for IRB approval, request for FDA approval, and total time to surgery were recorded, along with the specific pathway utilized for FDA approval. The average patient age was 12 years old (7-21 years old). The average time to IRB approval of a modification to the pre-approved protocol was 14 days (7-21 days). Average time to FDA approval after submission of the IRB approval to the manufacturer was 12.5 days (7-19 days). FDA approval was obtained for all implants as compassionate use requests in accordance with Section 561 of the Federal Food Drug and Cosmetic Act's expanded access provisions. Establishment of an institutional protocol with pre-approval by the IRB can expedite the otherwise time-consuming and complicated
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Cigarette constituent health communications for smokers: impact of chemical, imagery, and source.
Kowitt, Sarah; Sheeran, Paschal; Jarman, Kristen L; Ranney, Leah M; Schmidt, Allison M; Noar, Seth M; Huang, Li-Ling; Goldstein, Adam O
2017-10-03
Communication campaigns are incorporating tobacco constituent messaging to reach smokers, yet there is a dearth of research on how such messages should be constructed or will be received by smokers. In a 2x2x2 experiment, we manipulated three cigarette constituent message components: (1) the toxic constituent of tobacco (arsenic vs. lead) with a corresponding health effect, (2) the presence or absence of an evocative image, and (3) the source of the message (FDA vs. no source). We recruited smokers (N = 1,669, 55.4% women) via an online platform and randomized them to 1 of the 8 message conditions. Participants viewed the message and rated its believability and perceived effectiveness, the credibility of the message source, and action expectancies (i.e., likelihood of seeking additional information and help with quitting as a result of seeing the message). We found significant main effects of image, constituent, and source on outcomes. The use of arsenic as the constituent, the presence of an evocative image, and the FDA as the source increased the believability, source credibility, and perceived effectiveness of the tobacco constituent health message. Multiple elements of a constituent message, including type of constituent, imagery, and message source, impact their reception among smokers. Specifically, communication campaigns targeting smokers that utilize arsenic as the tobacco constituent, visual imagery, and the FDA logo may be particularly effective in changing key outcomes that are associated with subsequent attitude and behavioral changes. This paper describes how components of communication campaigns about cigarette constituents are perceived. Multiple elements of a tobacco constituent message, including type of constituent, image, and message source may influence the reception of messages among current smokers. Communication campaigns targeting smokers that utilize arsenic as the tobacco constituent, visual imagery, and the FDA logo may be particularly
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Communication with the public in radiation protection or nuclear safety and security
International Nuclear Information System (INIS)
Sabol, J.; Sestak, B.
2014-01-01
Traditionally, the public perceives any peaceful application of atomic and nuclear physics as something very dangerous. It is not easy to eliminate the public's memories of nuclear bombings in Japan towards the end of World War II and subsequent nuclear weapons tests which resulted in spreading radioactive fallout across the globe. The current use of radiation and nuclear technologies in industry, medicine, science and other fields is known to meet very strict international safety standards ensuring the adequate protection of people's health and the minimization of threat to the environment. The paper summarizes the current problems in communicating radiation and nuclear safety to members of the public and focuses on the importance of using appropriate approaches as well as relevant terminology, including quantities and units for the realistic assessment of radiological exposure. (authors)
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Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to ...
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Chapman, Benjamin; Eversley, Tiffany; Fillion, Katie; Maclaurin, Tanya; Powell, Douglas
2010-06-01
Globally, foodborne illness affects an estimated 30% of individuals annually. Meals prepared outside of the home are a risk factor for acquiring foodborne illness and have been implicated in up to 70% of traced outbreaks. The Centers for Disease Control and Prevention has called on food safety communicators to design new methods and messages aimed at increasing food safety risk-reduction practices from farm to fork. Food safety infosheets, a novel communication tool designed to appeal to food handlers and compel behavior change, were evaluated. Food safety infosheets were provided weekly to food handlers in working food service operations for 7 weeks. It was hypothesized that through the posting of food safety infosheets in highly visible locations, such as kitchen work areas and hand washing stations, that safe food handling behaviors of food service staff could be positively influenced. Using video observation, food handlers (n = 47) in eight food service operations were observed for a total of 348 h (pre- and postintervention combined). After the food safety infosheets were introduced, food handlers demonstrated a significant increase (6.7%, P < 0.05, 95% confidence interval) in mean hand washing attempts, and a significant reduction in indirect cross-contamination events (19.6%, P < 0.05, 95% confidence interval). Results of the research demonstrate that posting food safety infosheets is an effective intervention tool that positively influences the food safety behaviors of food handlers.
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Communication from the Safety Service
DG Unit - General Safety
In any emergency, you should call 74444 (+41 22 76 74444). There is something that bears repeating - especially in the light of recent events. The new Safety Bulletin, No. 2009-01, reminds us that, although raising the alarm and giving first aid in an emergency are everyone’s job, “medical transport is a job for professionals.” You are urged to read, print and share the Safety Bulletin No. 2009-01: remember for all emergencies you should dial 74444! We appreciate your comments and suggestions. Write to safety-general@cern.ch.
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International Nuclear Information System (INIS)
2012-01-01
The aims of this study are to establish a post-earthquake plant evaluation method and to develop a communication system for the improving seismic safety regulations as well as encouraging public communication. The Miyagiken-oki earthquake in 2005, Onagawa Nuclear Power Plant shut down automatically. Subsequently, JNES started development of post-earthquake plant evaluation and communication system based on the experience of the cross-check analysis for Onagawa Nuclear Power Plant. The Niigata-ken Chuetsu-oki Earthquake in 2007, the plant situation was not transmitted promptly. The loss of information sharing between local community and related organizations caused the public anxiety. The importance of plant information transmission as well as seismic information gathering were recognized. The proposal for the solution of the information issues were performed by government committee, In this study the evaluation method for soundness of the main structure and equipment after earthquake event were updated. Moreover, information dissemination to the public and transparent communication methodology was examined by the Industry-Academia-Government cooperation in the Kashiwazaki-Kariwa region. (author)
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The safety of pharmacologic treatment for pediatric obesity.
Chao, Ariana M; Wadden, Thomas A; Berkowitz, Robert I
2018-04-01
Pediatric obesity is a serious public health concern. Five medications have been approved by the Food and Drug Administration (FDA) for chronic weight management in adults with obesity, when used as an adjunct to lifestyle modification. Orlistat is the only FDA-approved medication for pediatric patients aged 12 years and above. Areas covered: This paper summarizes safety and efficacy data from clinical trials of weight loss medications conducted among pediatric samples. Relevant studies were identified through searches in PubMed. Expert opinion: Orlistat, as an adjunct to lifestyle modification, results in modest weight losses and may be beneficial for some pediatric patients with obesity. However, gastrointestinal side effects are common and may limit use. In adults taking orlistat, rare but severe adverse events, including liver and renal events, have been reported. Recent pediatric pharmacokinetic studies of liraglutide have demonstrated similar safety and tolerability profiles as found in adults, with gastrointestinal disorders being the most common adverse events. Clinical trials are needed of liraglutide, as well as other medications for obesity, that systematically evaluate their risks and benefits in pediatric patients.
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2013-11-20
... No. FDA-2011-N-0146] RIN 0910-AG66 Accreditation of Third-Party Auditors/Certification Bodies To... entitled ``Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to... proposed rule entitled ``Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety...
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Fassett, William E
2011-10-10
As colleges and schools of pharmacy develop core courses related to patient safety, course-level outcomes will need to include both knowledge and performance measures. Three key performance outcomes for patient safety coursework, measured at the course level, are the ability to perform root cause analyses and healthcare failure mode effects analyses, and the ability to generate effective safety communications using structured formats such as the Situation-Background-Assessment-Recommendation (SBAR) situational briefing model. Each of these skills is widely used in patient safety work and competence in their use is essential for a pharmacist's ability to contribute as a member of a patient safety team.
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2011-03-03
... (USVI). This action is necessary to meet the Commission's goals to improve public safety communications... Accordingly, it is ordered, pursuant to Sections 4(i) and 332 of the Communications Act of 1934, as amended... March 21, 2011. Sprint Nextel and relocating incumbents may agree to conduct face-to-face negotiations...
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2013-09-18
... help manage the safety of their global food supply chains. The purpose of these public meetings is to... submitting either electronic or written comments to FDA's Division of Dockets Management. ADDRESSES: See..., to better protect public health by helping to ensure the safety and security of the food supply. FSMA...
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Price, performance, and the FDA approval process: the example of home HIV testing.
Paltiel, A David; Pollack, Harold A
2010-01-01
The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process.
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Javitt, Gail H; Hudson, Kathy
2003-01-01
The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.
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Safety and effectiveness considerations for clinical studies of visual prosthetic devices
Cohen, Ethan D.
2007-03-01
With the advent of new designs of visual prostheses for the blind, FDA is faced with developing guidance for evaluating their engineering, safety and patient performance. Visual prostheses are considered significant risk medical devices, and their use in human clinical trials must be approved by FDA under an investigation device exemption (IDE). This paper contains a series of test topics and design issues that sponsors should consider in order to assess the safety and efficacy of their device. The IDE application includes a series of pre-clinical and clinical data sections. The pre-clinical section documents laboratory, animal and bench top performance tests of visual prostheses safety and reliability to support a human clinical trial. The materials used in constructing the implant should be biocompatible, sterile, corrosion resistant, and able to withstand any forces exerted on it during normal patient use. The clinical data section is composed of items related to patient-related evaluation of device performance. This section documents the implantation procedure, trial design, statistical analysis and how visual performance is assessed. Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness.
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2010-03-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...
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2013-08-16
... help manage the safety of their global food supply chains. The purpose of the public meeting is to... electronic or written comments to FDA's Division of Dockets Management. ADDRESSES: See section II, ``How to... protect public health by helping to ensure the safety and security of the food supply. FSMA amends the...
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21 CFR 5.1110 - FDA public information offices.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...) Press Relations Staff. Press offices are located in White Oak Bldg. 1, 10903 New Hampshire Ave., Silver...
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Stevens, W Grant; Harrington, Jennifer; Alizadeh, Kaveh; Broadway, David; Zeidler, Kamakshi; Godinez, Tess B
2015-05-01
On March 9, 2012, the Food and Drug Administration (FDA) approved Sientra's premarket approval application for its portfolio of silicone gel breast implants based on their review of Sientra's 3-year study data from the largest pivotal silicone gel breast implant study to date. This included the first approval of shaped breast implants in the United States. The authors provide an update to the 8-year safety and effectiveness of the Sientra High-Strength silicone gel breast implants. The Sientra Core study is an ongoing 10 year open-label, prospective, multi-center clinical study, which includes 1788 patients implanted with 3506 Sientra implants across four indications (Primary Augmentation, Revision Augmentation, Primary Reconstruction, and Revision Reconstruction). For the safety analysis, the incidence of post-operative complications, including all breast implant-related adverse effects (eg, infection, asymmetry), was estimated based on Kaplan-Meier risk rates. The effectiveness analyses include surgeon and patient satisfaction and changes in bra/cup size. Through 8 years, the overall risk of rupture was 4.6%, the risk of capsular contracture was 11.8% (rates were lower when using True Texture™), and the risk of reoperation was 28.3%. Out of the 580 reoperations in 456 patients, over half of all reoperations were due to cosmetic reasons (n = 299). The most common reasons for reoperation were capsular contracture (19.0%), style and/or size change (18.4%), and asymmetry (8.8%). Patient satisfaction remains high through 8 years, with 87% indicating that their breast implants make them feel more feminine than prior to enrollment. Safety data from the FDA Core study continues to support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped implants through 8 years. 3 Therapeutic. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.
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Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.
Caliendo, Angela M; Hanson, Kimberly E
2016-04-01
Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.
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International Nuclear Information System (INIS)
Zedler, Christien; Huber, Veit
2012-01-01
Nuclear power plant companies make efforts to enhance the operational safety in the plant. Despite a variety of measures the number of accidents at work is still too high, esp. for external personnel. Social psychological considerations were used to develop communication tools for the elimination of hazardous situations, for instance by safety dialogues between employees. The observation of hazardous situations should trigger communication and discussion on the risk of the specific situation. In the contribution practical experiences and recommendations for the realization of a safety dialogue culture in the NPP Grafenrheinfeld are summarized and illustrated by examples.
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Kang, Hong; Wang, Frank; Zhou, Sicheng; Miao, Qi; Gong, Yang
2017-01-01
Health information technology (HIT) events, a subtype of patient safety events, pose a major threat and barrier toward a safer healthcare system. It is crucial to gain a better understanding of the nature of the errors and adverse events caused by current HIT systems. The scarcity of HIT event-exclusive databases and event reporting systems indicates the challenge of identifying the HIT events from existing resources. FDA Manufacturer and User Facility Device Experience (MAUDE) database is a potential resource for HIT events. However, the low proportion and the rapid evolvement of HIT-related events present challenges for distinguishing them from other equipment failures and hazards. We proposed a strategy to identify and synchronize HIT events from MAUDE by using a filter based on structured features and classifiers based on unstructured features. The strategy will help us develop and grow an HIT event-exclusive database, keeping pace with updates to MAUDE toward shared learning.
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Hazarika, Maitreyee; Chuk, Meredith K; Theoret, Marc R; Mushti, Sirisha; He, Kun; Weis, Shawna L; Putman, Alexander H; Helms, Whitney S; Cao, Xianhua; Li, Hongshan; Zhao, Hong; Zhao, Liang; Welch, Joel; Graham, Laurie; Libeg, Meredith; Sridhara, Rajeshwari; Keegan, Patricia; Pazdur, Richard
2017-07-15
On December 22, 2014, the FDA granted accelerated approval to nivolumab (OPDIVO; Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Approval was based on a clinically meaningful, durable objective response rate (ORR) in a non-comparative analysis of 120 patients who received 3 mg/kg of nivolumab intravenously every 2 weeks with at least 6-month follow-up in an ongoing, randomized, open-label, active-controlled clinical trial. The ORR as assessed by a blinded independent review committee per RECIST v1.1 was 31.7% (95% confidence interval, 23.5-40.8). Ongoing responses were observed in 87% of responding patients, ranging from 2.6+ to 10+ months. In 13 patients, the response duration was 6 months or longer. The risks of nivolumab, including clinically significant immune-mediated adverse reactions (imARs), were assessed in 268 patients who received at least one dose of nivolumab. The FDA review considered whether the ORR and durations of responses were reasonably likely to predict clinical benefit, the adequacy of the safety database, and systematic approaches to the identification, description, and patient management for imARs in product labeling. Clin Cancer Res; 23(14); 3484-8. ©2017 AACR . ©2017 American Association for Cancer Research.
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International Nuclear Information System (INIS)
Iijima, Toru; Taoka, Hideto; Yamada, Hiroyuki; Sano, Kyoko
2011-01-01
The aims of this study are to establish a post-earthquake plant evaluation method and to develop a communication system for the improving seismic safety regulations as well as encouraging public communication. The Miyagiken-oki earthquake in 2005, Onagawa Nuclear Power Plant shut down automatically. Subsequently, JNES started development of post-earthquake plant evaluation and communication system based on the experience of the cross-check analysis for Onagawa Nuclear Power Plant. The Niigata-ken Chuetsu-oki Earthquake in 2007, the plant situation was not transmitted promptly. The loss of information sharing between local community and related organizations caused the public anxiety. The importance of plant information transmission as well as seismic information gathering were recognized. The proposal for the solution of the information issues were performed by government committee. In this study, the evaluation method for soundness of the main structure and equipment after earthquake event were updated. Moreover, procedure of the post-earthquake plant soundness evaluation and multi-functional seismic information system were developed. In addition, the implementation strategy of the easy-to -understand information dissemination to the public and transparent communication methodology was examined by the Industry-Academia-Government cooperation in the Kashiwazaki-Kariwa region. (author)
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Wiseman, Samuel R
2015-01-01
In the wake of growing public concerns over salmonella outbreaks and other highly publicized food safety issues, Congress passed the FDA Food Safety Modernization Act in 2011, which placed more stringent standards on food growing and packaging operations. In negotiations preceding the Act's passage, farmers of local, sustainable food argued that these rules would unduly burden local agricultural operations or, at the extreme, drive them out of business by creating overly burdensome rules. These objections culminated in the addition of the Tester-Hagan Amendment to the Food Safety Modernization Act, which created certain exemptions for small farms. Proposed Food and Drug Administration (FDA) rules to implement the Act threatened to weaken this victory for small farm groups, however, prompting a loud response from small farmers and local food proponents. The FDA's second set of proposed rules, issued in September 2014 in response to these and other complaints, were, perhaps surprisingly, responsive to small farmers' concerns. Using comments submitted to the FDA, this article explores the responses of the agriculture industry and public health organizations, as well as small farm groups, consumers of local food, and sustainable agriculture interests (which, for simplicity, I alternately describe as comprising the "sustainable agriculture" or "small farm" movement), to three aspects of the FDA's proposed rules--involving manure application, on-farm packing activities, and exemptions for very small farms--to assess the strength of the sustainable agriculture movement. The rules involving manure application and on-farm packing, it turns out, reveal little about the independent political strength of the local food movement, as large industry groups also objected to these provisions. But for the third issue discussed here--exemptions for very small farms--the interests of sustainable agriculture groups were directly opposed to both industry and public health organizations
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We really need to talk: adapting FDA processes to rapid change.
Lykken, Sara
2013-01-01
The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.
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THPdb: Database of FDA-approved peptide and protein therapeutics.
Directory of Open Access Journals (Sweden)
Salman Sadullah Usmani
Full Text Available THPdb (http://crdd.osdd.net/raghava/thpdb/ is a manually curated repository of Food and Drug Administration (FDA approved therapeutic peptides and proteins. The information in THPdb has been compiled from 985 research publications, 70 patents and other resources like DrugBank. The current version of the database holds a total of 852 entries, providing comprehensive information on 239 US-FDA approved therapeutic peptides and proteins and their 380 drug variants. The information on each peptide and protein includes their sequences, chemical properties, composition, disease area, mode of activity, physical appearance, category or pharmacological class, pharmacodynamics, route of administration, toxicity, target of activity, etc. In addition, we have annotated the structure of most of the protein and peptides. A number of user-friendly tools have been integrated to facilitate easy browsing and data analysis. To assist scientific community, a web interface and mobile App have also been developed.
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Communication. Problem learning in the communication across expert areas
International Nuclear Information System (INIS)
Drottz Sjoeberg, B. M.
2001-05-01
The report presents results from a project on communication involving nuclear safety personnel and members of the safety council and personnel in administrative positions within the community of Oskarshamn. Data were collected in discussions and by questionnaires. Totally 42 persons participated in the study. The aim of the project was to pinpoint problems in communication about safety issues and thus to facilitate a development of communication between groups and in the work on nuclear safety within the local community. A number of open ended questions were included in the questionnaire together with large number of rating tasks. The participants rated items, developed primarily in the group discussions, regarding information transmission, handling of difficult situations and what could be done to improve the communication situation. The results showed e.g. that communicative ability was best predicted by the index of 'context uncertainty' in both groups, but that the groups differed with respect to the salience of other predictors. Thus, an index named 'ability to synthesize' was a good predictor in the group of nuclear personnel, whereas human and structural aspects of information transmission, as well as the ability to reach across boundaries, were additional predictors in the group of Oskarshamn community personnel. The results thus showed that the participants viewed communication problems and solutions from the perspective of their own work perspective rather than as issues to be dealt with across different expert groups. The report underlines the necessity to regard contents of communicated messages as well as the framework to which they are related within the same context for an optimal adjustment to expectations, attitudes and requirements. Suggestions for future work included clarifications of which groups that are relevant for information and their specific interests, increased clarity regarding specific roles and information paths with respect to
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2010-10-01
..., November 1-5, 2010. The Under Secretary for Food Safety and FDA recognizes the importance of providing... require alternative means for communication of program information (Braille, large print, or audiotape... for industry, trade groups, consumer interest groups, health professionals, and other individuals who...
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Fault-Tree Modeling of Safety-Critical Network Communication in a Digitalized Nuclear Power Plant
Energy Technology Data Exchange (ETDEWEB)
Lee, Sang Hun; Kang, Hyun Gook [KAIST, Daejeon (Korea, Republic of)
2015-10-15
To achieve technical self-reliance for nuclear I and C systems in Korea, the Advanced Power Reactor 1400 (APR-1400) man-machine interface system (MMIS) architecture was developed by the Korea Atomic Energy Research Institute (KAERI). As one of the systems in the developed MMIS architecture, the Engineered Safety Feature-Component Control System (ESF-CCS) employs a network communication system for the transmission of safety-critical information from group controllers (GCs) to loop controllers (LCs) to effectively accommodate the vast number of field controllers. The developed fault-tree model was then applied to several case studies. As an example of the development of a fault-tree model for ESF-CCS signal failure, the fault-tree model of ESF-CCS signal failure for CS pump PP01A in the CSAS condition was designed by considering the identified hazardous states of network failure that would result in a failure to provide input signals to the corresponding LC. The quantitative results for four case studies demonstrated that the probability of overall network communication failure, which was calculated as the sum of the failure probability associated with each failure cause, contributes up to 1.88% of the probability of ESF-CCS signal failure for the CS pump considered in the case studies.
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Effective communication and teamwork promotes patient safety.
Gluyas, Heather
2015-08-05
Teamwork requires co-operation, co-ordination and communication between members of a team to achieve desired outcomes. In industries with a high degree of risk, such as health care, effective teamwork has been shown to achieve team goals successfully and efficiently, with fewer errors. This article introduces behaviours that support communication, co-operation and co-ordination in teams. The central role of communication in enabling co-operation and co-ordination is explored. A human factors perspective is used to examine tools to improve communication and identify barriers to effective team communication in health care.
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International Nuclear Information System (INIS)
Andersson, K.; Sjoeberg, B.M.D.; Lauridsen, K.; Wahlstroem, B.
2002-06-01
The aim of the NKS/SOS-1 project has been to enhance common understanding about requirements for nuclear safety by finding improved means of communicating on the subject in society. The project, which has been built around a number of seminars, was supported by limited research in three sub-projects: 1) Risk assessment, 2) Safety analysis, and 3) Strategies for safety management. The report describes an industry in change due to societal factors. The concepts of risk and safety, safety management and systems for regulatory oversight are described in the nuclear area and also, to widen the perspective, for other industrial areas. Transparency and public participation are described as key elements in good risk communication, and case studies are given. Environmental Impact Assessment and Strategic Environmental Assessment are described as important overall processes within which risk communication can take place. Safety culture, safety indicators and quality systems are important concepts in the nuclear safety area are very useful, but also offer important challenges for the future. They have been subject to special attention in the project. (au)
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Usefulness of [18F]-DA and [18F]-DOPA for PET imaging in a mouse model of pheochromocytoma
International Nuclear Information System (INIS)
Martiniova, Lucia; Cleary, Susannah; Lai, Edwin W.; Kiesewetter, Dale O.; Seidel, Jurgen; Dawson, Linda F.; Phillips, Jacqueline K.; Thomasson, David; Chen Xiaoyuan; Eisenhofer, Graeme; Powers, James F.; Kvetnansky, Richard
2012-01-01
Purpose: To evaluate the usefulness of [ 18 F]-6-fluorodopamine ([ 18 F]-DA) and [ 18 F]-L-6-fluoro-3,4-dihydroxyphenylalanine ([ 18 F]-DOPA) positron emission tomography (PET) in the detection of subcutaneous (s.c.) and metastatic pheochromocytoma in mice; to assess the expression of the norepinephrine transporter (NET) and vesicular monoamine transporters 1 and 2 (VMAT1 and VMAT2), all important for [ 18 F]-DA and [ 18 F]-DOPA uptake. Furthermore, to compare tumor detection by micro-computed tomography (microCT) to magnetic resonance imaging (MRI) in individual mouse. Methods: SUV max values were calculated from [ 18 F]-DA and [ 18 F]-DOPA PET, tumor-to-liver ratios (TLR) were obtained and expression of NET, VMAT1 and VMAT2 was evaluated. Results: [ 18 F]-DA detected less metastatic lesions compared to [ 18 F]-DOPA. TLR values for liver metastases were 2.26–2.71 for [ 18 F]-DOPA and 1.83–2.83 for [ 18 F]-DA. A limited uptake of [ 18 F]-DA was found in s.c. tumors (TLR=0.22-0.27) compared to [ 18 F]-DOPA (TLR=1.56-2.24). Overall, NET and VMAT2 were expressed in all organ and s.c. tumors. However, s.c. tumors lacked expression of VMAT1. We confirmed [ 18 F]-DA's high affinity for the NET for its uptake and VMAT1 and VMAT2 for its storage and retention in pheochromocytoma cell vesicles. In contrast, [ 18 F]-DOPA was found to utilize only VMAT2. Conclusion: MRI was superior in the detection of all organ tumors compared to microCT and PET. [ 18 F]-DOPA had overall better sensitivity than [ 18 F]-DA for the detection of metastases. Subcutaneous tumors were localized only with [ 18 F]-DOPA, a finding that may reflect differences in expression of VMAT1 and VMAT2, perhaps similar to some patients with pheochromocytoma where [ 18 F]-DOPA provides better visualization of lesions than [ 18 F]-DA.
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2010-07-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0260... Defense, Communication and Emergency Response (HFS- 005), Center for Food Safety and Applied Nutrition...., College Park, MD 20740, 301-436-1807. SUPPLEMENTARY INFORMATION: I. Introduction The Reportable Food...
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2011-01-20
... Under Secretary for Food Safety and the FDA recognize the importance of providing interested parties the... international groups working in methods of analysis and sampling and quality assurance systems for laboratories... apply to all programs.) Persons with disabilities who require alternative means for communication of...
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Premarket safety and efficacy studies for ADHD medications in children.
Directory of Open Access Journals (Sweden)
Florence T Bourgeois
Full Text Available Attention-deficit hyperactivity disorder (ADHD is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing.We identified all ADHD medications approved by the Food and Drug Administration (FDA and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug's clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials.A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419. Eleven drugs (55% were approved after <100 participants were studied and 14 (70% after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9, with 5 (38% drugs approved after participants were studied <4 weeks and 10 (77% after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed.Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved.
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Pediatric post-marketing safety systems in North America: assessment of the current status.
McMahon, Ann W; Wharton, Gerold T; Bonnel, Renan; DeCelle, Mary; Swank, Kimberley; Testoni, Daniela; Cope, Judith U; Smith, Phillip Brian; Wu, Eileen; Murphy, Mary Dianne
2015-08-01
It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. Copyright © 2015 John Wiley & Sons, Ltd.
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The safety and efficacy of lorcaserin in the management of obesity.
Hess, Rick; Cross, L Brian
2013-11-01
Lorcaserin represents a new serotonergic medication used as an adjunct to a reduced-calorie diet and increased physical activity treatment plan for chronic weight management in adult patients with an initial body mass index ≥ 30 kg/m 2 or in adult patients with an initial body mass index ≥ 27 kg/m 2 who have ≥ 1 comorbid condition associated with weight (eg, hypertension, dyslipidemia, or type 2 diabetes mellitus). In 2012, lorcaserin became the first obesity treatment medication to gain US Food and Drug Administration (FDA) approval since 1999. Lorcaserin is a centrally acting, selective serotonin C (5-HT2C) receptor full agonist that is associated with increased satiety and decreased food consumption in patients. The selectivity of lorcaserin for 5-HT2C receptors should reduce patient risk for the serious adverse complications that are associated with nonselective 5-HT agonist therapies, such as cardiac valvulopathy and pulmonary hypertension. The safety and efficacy of lorcaserin (10 mg twice daily) for ≥ 52 weeks has been evaluated in 3 separate Phase 3 trials. The primary outcome of patient weight loss in the 3 trials satisfied the FDA categorical benchmark but patient outcomes in the trials failed to achieve the FDA mean benchmark of patient weight loss. Secondary patient outcomes after lorcaserin therapy were favorable. Lorcaserin appears to be well tolerated in patients and the most common adverse events reported did not include serious complications. The incidence of FDA-defined valvulopathy in patients after 1 year of treatment was low and nonsignificant, but the statistical analysis of this safety endpoint was limited due to the small size of the study populations and high patient dropout rates. Continued post-marketing surveillance of patients taking lorcaserin is warranted.
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78 FR 37228 - Cooperative Agreement To Support the Western Center for Food Safety
2013-06-20
... FSMA activities. FDA regards the development and strengthening of public-private partnerships to be a... agricultural producers, along with other public and private stakeholders. This established UC Davis network... study the agro- ecological differences that may impact food safety in the agricultural sector. WCFS has...
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Fisher, Neyman, and Bayes at FDA.
Rubin, Donald B
2016-01-01
The wise use of statistical ideas in practice essentially requires some Bayesian thinking, in contrast to the classical rigid frequentist dogma. This dogma too often has seemed to influence the applications of statistics, even at agencies like the FDA. Greg Campbell was one of the most important advocates there for more nuanced modes of thought, especially Bayesian statistics. Because two brilliant statisticians, Ronald Fisher and Jerzy Neyman, are often credited with instilling the traditional frequentist approach in current practice, I argue that both men were actually seeking very Bayesian answers, and neither would have endorsed the rigid application of their ideas.
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Security and privacy qualities of medical devices: an analysis of FDA postmarket surveillance.
Kramer, Daniel B; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R
2012-01-01
Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.
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Three Drugs Approved for Urothelial Carcinoma by FDA.
2017-07-01
The FDA has approved one PD-1 checkpoint inhibitor, pembrolizumab, and two PD-L1 checkpoint inhibitors, avelumab and durvalumab, to treat metastatic urothelial carcinoma in patients whose disease continues to progress despite platinum-based chemotherapy. This brings the total number of checkpoint inhibitors for the disease to five, prompting questions about how best to use them. ©2017 American Association for Cancer Research.
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Safety Awareness & Communications Internship
Jefferson, Zanani
2015-01-01
The projects that I have worked on during my internships were updating the JSC Safety & Health Action Team JSAT Employee Guidebook, conducting a JSC mishap case study, preparing for JSC Today Close Call success stories, and assisting with event planning and awareness.
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Risk evaluation and mitigation strategies (REMS): educating the prescriber.
Nicholson, Susan C; Peterson, Janet; Yektashenas, Behin
2012-02-01
The US FDA Amendments Act of 2007 was signed into law on 27 September 2007. A provision of this law granted the FDA new powers to enhance drug safety by requiring the pharmaceutical industry to develop Risk Evaluation and Mitigation Strategies (REMS). REMS are deemed necessary when a question exists as to whether the benefits of a drug outweigh its risks. REMS constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients. This applies to existing drugs on the market, new drug applications (NDAs), abbreviated NDAs (generics) and biologics licence applications. REMS represent an 'upgrade' from previously required risk minimization action plans, based on the strengthening of FDA powers of authority and enforceability to incur monetary penalties against individuals representing the pharmaceutical industry who fail to comply. For illustrative purposes, we chose the drug romiplostim (Nplate®) to present an REMS, as all components were utilized to help assuage risks associated with the drug. Romiplostim is an FDA-approved drug used to treat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura that has a significant adverse safety profile based on the risk of changes in bone marrow reticulin formation and bone marrow fibroses, and other associated risks. This review of current REMS policy is intended to provide the prescriber with a better understanding of current modalities in FDA-mandated drug safety programmes, which will impact day-to-day healthcare provider practices.
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International Nuclear Information System (INIS)
Keen, L.J.
2003-01-01
Safety culture has become a topic of increasing interest for industry and regulators as issues are raised on safety problems around the world. The keys to safety culture are organizational effectiveness, effective communications, organizational learning, and a culture that encourages the identification and resolution of safety issues. The necessity of a strong safety culture places an onus on all of us to continually question whether the safety measures already in place are sufficient, and are being applied. (author)
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Industry challenge to best practice risk communication.
McEntire, J; Boateng, A
2012-04-01
Effective food safety and food defense risk communication helps to inform consumers without causing panic and alarm. The Risk Communication Team of the Natl. Center for Food Protection and Defense has developed a list of 11 best practices recommended for effective risk communication. These practices, designed for a food defense crisis, are currently applied to food safety issues, since fortunately a food defense crisis has yet to occur. IFT examined the utility of these best practices and the limitations on their use during food safety and food defense crises by academics, trade associations, and the government. It was hypothesized that legal and business considerations as well as the nature of the event would determine the implementation of the best practices. Through the use of focus group meetings, it was discovered that there was a low level of awareness of the best practices. However, stakeholders practiced some aspects of the recommended practices. Participants felt some of the practices were related and could be consolidated. They also agreed that a food defense event will increase the urgency of the communication and include players not typically involved in food safety issues. The challenges reported by the stakeholders varied, but legal liability, as well as the impact their communications could have on an industry, were often cited. From the government perspective, their need to act within their authorities drove some of their actions with respect to communication. Determining the differences in communication limitations during food safety against food defense events can provide key information to further developing and refining risk communications and specific messages targeted for a food defense incident. Effective food safety and food defense risk communication helps to inform consumers without causing panic and alarm. Determining the differences in communication limitations during food safety against food defense events can provide key information to
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1995-02-01
The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.
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Atchison, Chris
2017-01-01
Background The capacity to advertise via the Internet continues to contribute to the shifting dynamics in adult commercial sex work. eHealth interventions have shown promise to promote Internet-based sex workers’ health and safety internationally, yet minimal attention has been paid in Canada to developing such interventions. Understanding the information communicated in Internet-based sex work advertisements is a critical step in knowledge development to inform such interventions. Objective The purpose of this content analysis was to increase our understanding of the health and safety information within the Internet advertisements among women, men, and transgender sex workers and to describe how this information may be utilized to inform eHealth service development for this population. Methods A total of 75 Internet-based sex worker advertisements (45 women, 24 men, and 6 transgender persons) were purposefully selected from 226 advertisements collected as part of a larger study in Western Canada. Content analysis was employed to guide data extraction about demographic characteristics, sexual services provided, service restrictions, health practices and concerns, safety and security, and business practices. Frequencies for each variable were calculated and further classified by gender. Thematic analysis was then undertaken to situate the communications within the social and commercialized contexts of the sex industry. Results Four communications themes were identified: (1) demographic characteristics; (2) sexual services; (3) health; and (4) safety and security. White was the most common ethnicity (46/75, 61%) of advertisements. It was found that 20-29 years of age accounted for 32 of the 51 advertisements that provided age. Escort, the only legal business title, was the most common role title used (48/75, 64%). In total, 85% (64/75) of advertisements detailed lists of sexual services provided and 41% (31/75) of advertisements noted never offering uncovered
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Think over nuclear safety. ''Information asymmetry'' and ''comminicative action''
International Nuclear Information System (INIS)
Suzuki, Atsuyuki
2006-01-01
Nuclear safety should be fully understood not only technically but also socially. In order to think over nuclear safety socially, four different concepts were recommended to refer, which were ''procedural rationality'', information asymmetry'', ''certainty effect'' and ''communicative action'' proposed by three economists and a philosopher respectively. Risk-based communication approach for nuclear safety could be effective within the higher frequency area than safety goal, but not good for the lower frequency area than safety goal. The latter could be highly subjective and more qualitative. For this area, ''safety communication'' would be highly maintained with taking account of existence of ''information asymmetry'' and need of ''communicative action''. (T.Tanaka)
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Bastiaans, D.E.T.; Forcat, S.; Lyall, H.; Cressey, T.R.; Hansudewechakul, R.; Kanjanavanit, S.; Noguera-Julian, A.; Konigs, C.; Inshaw, J.R.; Chalermpantmetagul, S.; Saidi, Y.; Compagnucci, A.; Harper, L.M.; Giaquinto, C.; Colbers, A.P.; Burger, D.M.
2014-01-01
BACKGROUND: Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval
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2013-06-14
... recommendations that FDA believes the sponsor should consider in preparation for a marketing application or a... this new provision and to introduce the communication to the sponsor of study design-related issues. If... subject safety, for the study design to be adequate and ultimately support a marketing application, if...
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Huang, Fanghua
2010-04-01
Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine.
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Directory of Open Access Journals (Sweden)
Gilhyang Kim
2016-11-01
Full Text Available Background Human epidermal growth factor receptor 2 (HER2 is one of the known oncogenes in urothelial carcinoma. However, the association between HER2 and the prognosis of upper urinary tract urothelial carcinoma (UUTUC has not yet been fully clarified. The aim of this study was to evaluate HER2 expression using the United States Food and Drug Administration (FDA criteria and American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP criteria and compare their prognostic significance in UUTUC. Methods HER2 expression was evaluated in 144 cases of UUTUC by immunohistochemistry (IHC using tissue microarrays. We separately analyzed HER2 expression using the FDA and ASCO/CAP criteria. The IHC results were categorized into low (0, 1+ and high (2+, 3+ groups. Results Using the FDA criteria, 94 cases were negative, 38 cases were 1+, nine cases were 2+, and three cases were 3+. Using the ASCO/CAP criteria, 94 cases were negative, 34 cases were 1+, 13 cases were 2+, and three cases were 3+. Four cases showing 2+ according to the ASCO/CAP criteria were reclassified as 1+ by the FDA criteria. High HER2 expression by both the FDA criteria and ASCO/CAP criteria was significantly associated with International Society of Urological Pathology high grade (p = .001 and p < .001. The high HER2 expression group classified with the FDA criteria showed significantly shorter cancer-specific survival (p = .004, but the HER2 high and low expression groups classified with the ASCO/CAP criteria did not show significant differences (p = .161 in cancer-specific survival. Conclusions HER2 high expression groups were significantly associated with shorter cancer-specific survival, and our study revealed that the FDA criteria are more suitable for determining HER2 expression in UUTUC.
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Liebhart, Rainer; Wong, Curt; Merkel , Jürgen
2015-01-01
The aim of the book is to educate government agencies, operators, vendors and other regulatory institutions how LTE can be deployed to serve public safety market and offer regulatory / public safety features. It is written in such a way that it can be understood by both technical and non-technical personnel with just introductory knowledge in wireless communication. Some sections and chapters about public safety services offered by LTE network are intended to be understood by anyone with no knowledge in wireless communication.
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Communication and Public Information in Development and Maintenance of Radiation Safety
International Nuclear Information System (INIS)
Huurto, L.
2003-01-01
The natural source of Non-Ionizing radiation (NIR) in our environment is the sun. Artificial NIR is widely used in medical and industrial applications and also in households. The most important medical NIR applications are phototherapy, surgical lasers and magnetic resonance imaging. In industry NIR is applied in radio frequency heaters and laser printing. NIR has applications even in entertainment and cosmetics: High power lasers are used in light shows and sun beds emit artificial ultraviolet radiation (UVR) for tanning. From the safety point of view the field is indeed very wide from harmless and common items to devices which can cause acute health hazards. The use of non-ionizing radiation needs neither any safety licence nor other kind of authorisation. The users of NIR devices varies from professionals in health care or lighting technology to those who only use them as a sideline in their main work like beauticians. Also laypersons use various NIR devices like microwave ovens, laser pointers and mobile phones. Many NIR devices are used in applications where the user does not have the knowledge to understand the health risks associated with the device. Thus the only way is to educate the users by communication and public information. (orig.)
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Timelines of translational science: From technology initiation to FDA approval.
Directory of Open Access Journals (Sweden)
Laura M McNamee
Full Text Available While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p<0.0005. Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.
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FDA, CE mark or something else?-Thinking fast and slow.
Mishra, Sundeep
There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.
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Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review
Directory of Open Access Journals (Sweden)
Juan Carlos Martínez-Aguayo
2016-06-01
Full Text Available ABSTRACT Background The United States Food and Drug Administration (FDA has warned about the increased suicidality risk associated with the use of selective serotonin reuptake inhibitors (SSRI and venlafaxine in children and adolescents. Objectives To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents. Methods A critical review of articles in Medline/PubMed and SciELO databases regarding the FDA Black box warning for antidepressants, and the impact of FDA warnings on antidepressant prescriptions and suicide rates. Results The warning was based on surveys that did not report either cases of suicide nor a significant difference supporting an increased suicidality rate. The concept was defined in an ambiguous way and there is currently more available evidence to support such definition. The use of SSRI and venlafaxine has been associated to lower suicidality rates, but the prescription fall due to the warning increased suicide rates. Discussion Suicidality is an inherent feature of depressive disorders so it would be desirable to consider how much of the phenomenon may be attributed to antidepressants per se. It would be appropriate to consider that suicide rates might increase also as a consequence of the warning.
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Zimmerman, Mark
2016-06-01
According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored. © The Royal College of Psychiatrists 2016.
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Posner, Kelly; Oquendo, Maria A; Gould, Madelyn; Stanley, Barbara; Davies, Mark
2007-07-01
To evaluate the link between antidepressants and suicidal behavior and ideation (suicidality) in youth, adverse events from pediatric clinical trials were classified in order to identify suicidal events. The authors describe the Columbia Classification Algorithm for Suicide Assessment (C-CASA), a standardized suicidal rating system that provided data for the pediatric suicidal risk analysis of antidepressants conducted by the Food and Drug Administration (FDA). Adverse events (N=427) from 25 pediatric antidepressant clinical trials were systematically identified by pharmaceutical companies. Randomly assigned adverse events were evaluated by three of nine independent expert suicidologists using the Columbia classification algorithm. Reliability of the C-CASA ratings and agreement with pharmaceutical company classification were estimated. Twenty-six new, possibly suicidal events (behavior and ideation) that were not originally identified by pharmaceutical companies were identified in the C-CASA, and 12 events originally labeled as suicidal by pharmaceutical companies were eliminated, which resulted in a total of 38 discrepant ratings. For the specific label of "suicide attempt," a relatively low level of agreement was observed between the C-CASA and pharmaceutical company ratings, with the C-CASA reporting a 50% reduction in ratings. Thus, although the C-CASA resulted in the identification of more suicidal events overall, fewer events were classified as suicide attempts. Additionally, the C-CASA ratings were highly reliable (intraclass correlation coefficient [ICC]=0.89). Utilizing a methodical, anchored approach to categorizing suicidality provides an accurate and comprehensive identification of suicidal events. The FDA's audit of the C-CASA demonstrated excellent transportability of this approach. The Columbia algorithm was used to classify suicidal adverse events in the recent FDA adult antidepressant safety analyses and has also been mandated to be applied to all
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Mayday system infiniti communicator; Kinkyu tsuho system Infiniti Communicator
Energy Technology Data Exchange (ETDEWEB)
Iijima, Y.; Ito, T.; Isono, Y.; Sekiya, M.; Koizumi, H.; Miyazaki, S.; Kishore, A.; Lawor, D. [Nissan Motor Co. Ltd., Tokyo (Japan)
1999-02-01
To respond to emergency situations associated with vehicle accidents and mechanical problems on the road, a novel emergency communication system, which combines vehicle electronics, GPS and communication systems, has been developed and is contributing to safety in the U.S. In addition to emergency communication, other features including theft protection, security, convenience features, etc. are to be added to this system in the future. An emergency communication system, `The Infiniti Communicator`, which began its service in March 1998 under such a market trend, is explained in this report. (author)
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Auerbach, Andrew D; Sehgal, Niraj L; Blegen, Mary A; Maselli, Judith; Alldredge, Brian K; Vittinghoff, Eric; Wachter, Robert M
2012-02-01
Improving communication between caregivers is an important approach to improving safety. To implement teamwork and communication interventions and evaluate their impact on patient outcomes. A prospective, interrupted time series of a three-phase a run-in period (phase 1), during which a training programme was given to providers and staff on each unit; phase 2, which focused on unit-based safety teams to identify and address care problems using skills from phase 1; and phase 3, which focused on engaging patients in communication efforts. General medical inpatient units at three northern California hospitals. Administrative data were collected from all adults admitted to the target units, and a convenience sample of patients interviewed during and after hospitalisation. Readmission, length of stay and patient reports of teamwork, problems with care, and overall satisfaction. 10 977 patients were admitted; 581 patients (5.3% of total sample) were interviewed in hospital, and 313 (2.9% overall, 53.8% of interviewed patients) completed 1-month surveys. No phase of the study was associated with adjusted differences in readmission or length of stay. The phase 2 intervention appeared to be associated with improvement in reports of whether physicians treated them with respect, whether nurses treated them with respect or understood their needs (pcommunication may improve patients' perception of team functions, but may also increase patients' perception of safety gaps.
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Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.
Bradford, W David; Kleit, Andrew N
2015-07-01
Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. Copyright © 2014 John Wiley & Sons, Ltd.
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Patient safety culture among nurses.
Ammouri, A A; Tailakh, A K; Muliira, J K; Geethakrishnan, R; Al Kindi, S N
2015-03-01
Patient safety is considered to be crucial to healthcare quality and is one of the major parameters monitored by all healthcare organizations around the world. Nurses play a vital role in maintaining and promoting patient safety due to the nature of their work. The purpose of this study was to investigate nurses' perceptions about patient safety culture and to identify the factors that need to be emphasized in order to develop and maintain the culture of safety among nurses in Oman. A descriptive and cross-sectional design was used. Patient safety culture was assessed by using the Hospital Survey on Patient Safety Culture among 414 registered nurses working in four major governmental hospitals in Oman. Descriptive statistics and general linear regression were employed to assess the association between patient safety culture and demographic variables. Nurses who perceived more supervisor or manager expectations, feedback and communications about errors, teamwork across hospital units, and hospital handoffs and transitions had more overall perception of patient safety. Nurses who perceived more teamwork within units and more feedback and communications about errors had more frequency of events reported. Furthermore, nurses who had more years of experience and were working in teaching hospitals had more perception of patient safety culture. Learning and continuous improvement, hospital management support, supervisor/manager expectations, feedback and communications about error, teamwork, hospital handoffs and transitions were found to be major patient safety culture predictors. Investing in practices and systems that focus on improving these aspects is likely to enhance the culture of patient safety in Omani hospitals and others like them. Strategies to nurture patient safety culture in Omani hospitals should focus upon building leadership capacity that support open communication, blame free, team work and continuous organizational learning. © 2014 International
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Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance
Kramer, Daniel B.; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R.
2012-01-01
Background Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware. PMID:22829874
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2013-02-13
...] Global Quality Systems--An Integrated Approach To Improving Medical Product Safety; Public Workshop... (AFDO), is announcing a public workshop entitled ``Global Quality Systems--An Integrated Approach to... topics concerning FDA requirements related to the production and marketing of drugs and/or devices...
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Pfrimmer, Dale
2009-07-01
Effective teamwork and communication is critical to the delivery of safe and reliable patient care. Communication breakdowns account for the overwhelming majority of sentinel events. Effective teamwork and communication can help prevent mistakes and decrease patient risk. The implementation of simple tools and behaviors can greatly enhance patient safety and improve perceptions of teamwork.
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A history of studies on safety of irradiated foods
International Nuclear Information System (INIS)
Miyahara, Makoto
2003-01-01
This report explained a history of studies on safety of irradiated foods in the United States. The army of USA had begun an experiment of irradiated foods in 1953. The toxic tests consisted of three phase, the phase I (1954 to 1959), phase II (1956 to 1965) and phase III (1971 to 1978). In the phase I, the short period toxic tests (90days) of 54 kinds of foods were carried out using high and low irradiation. The Swift and Company Laboratories reported detailed animal tests of 2685 albino rat, chickens and human. The animal tests showed many kinds of nutrition disorder, but the human test no problem. On phase II, 22 kinds of foods were tested for long period using rat, dog and mouse. Dog showed many kinds of symptom, for example, low birthrate, short life time, low growth rate, increasing spleen weight and thyroid disease. On phase III, two companies carried out the toxic test and Ralston Purina Company report is only data to be used now. Atomic Energy Commission (AEC) (1960 to 1970), Department of Commerce (1965 to 1976) and Department of Agriculture (1961 to 1966) studied safety of irradiated foods. Food and Drug Administration (FDA) determined that the irradiated foods belonged to under the category of food additive in 1958. FDA tests safety of irradiated foods using the determination tree and permitted many kinds of irradiated foods. (S.Y.)
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FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR
An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing. Br
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Reliability Analysis Techniques for Communication Networks in Nuclear Power Plant
International Nuclear Information System (INIS)
Lim, T. J.; Jang, S. C.; Kang, H. G.; Kim, M. C.; Eom, H. S.; Lee, H. J.
2006-09-01
The objectives of this project is to investigate and study existing reliability analysis techniques for communication networks in order to develop reliability analysis models for nuclear power plant's safety-critical networks. It is necessary to make a comprehensive survey of current methodologies for communication network reliability. Major outputs of this study are design characteristics of safety-critical communication networks, efficient algorithms for quantifying reliability of communication networks, and preliminary models for assessing reliability of safety-critical communication networks
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Yang, Tubao; Walker, Mark C; Krewski, Daniel; Yang, Qiuying; Nimrod, Carl; Garner, Peter; Fraser, William; Olatunbosun, Olufemi; Wen, Shi Wu
2008-03-01
To estimate the frequency of exposure to prescription Food and Drug Administration (FDA) category C, D, and X drugs in pregnant women, and to analyze the maternal characteristics associated with such an exposure. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 was chosen for the study. The rate of exposure to FDA category C, D, or X drugs recorded in the pharmacist database was estimated. Associations of exposure to FDA category C, D, and X drugs with maternal characteristics were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 575 women were included in this study. Among them, 3604 (19.4%) had exposure to one or more FDA category C, D, and X drugs during pregnancy. Category C drugs were the most frequently used drugs (15.8%), followed by D drugs (5.2%), and X drugs (3.9%). Women with chronic health conditions had fourfold at increased risk of exposure than women without. Regardless of health status, women who were or =3, and who were on social assistance plan were at increased risk of pregnancy exposure to these drugs. About 19.4% pregnant women are exposed to FDA C, D or X drugs during pregnancy. Women with chronic diseases, younger age, increased parity, and under social assistance are at increased risk of exposure to FDA C, D, or X drugs. Copyright 2008 John Wiley & Sons, Ltd.
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FDA Developments: Food Code 2013 and Proposed Trans Fat Determination
Grossman, M.R.
2014-01-01
268 Reports EFFL 4|2014 USA FDA Developments: Food Code 2013 and Proposed Trans Fat Determination Margaret Rosso Grossman* I. Food Code 2013 and Food Code Reference System Since 1993, the US Food and Drug Administration has published a Food Code, now updated every four years. In November 2013, the
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Directory of Open Access Journals (Sweden)
Shu-Chiang Lin
2017-10-01
Full Text Available The present study aims to assess the safety-climate level in Taiwan’s metal industries, as well as to identify the influence of workers’ backgrounds on the safety climate. An earlier report showed that a poor safety culture was related to the cause of accidents in Taiwan’s traditional manufacturing industries. This study surveyed a total of 839 workers who voluntarily participated and completed the safety-culture questionnaires. These workers were from a Taiwanese metal company and its five satellite companies. Three safety-climate factors, namely safety perception, safety communication and safety-management systems, were assessed. Confirmatory factor analysis (CFA was conducted by developing structural equation modeling to ensure the questionnaire’s validity. The influence of workers’ backgrounds on the safety climate was identified by using one-way ANOVA. The reliability result of the questionnaire was above the acceptable level. The overall safety-climate score was 4.22 out of a five-point scale for safety perception, 4.23 for safety-management systems and 3.97 for safety communication. The scores indicate a good level of safety climate, with room for improvement in safety communication. Additionally, the influence of workers’ backgrounds on the safety climate was confirmed. Based on the validity test, it was also found that the questionnaire could be improved by reconstructing its questions in its development process in order to increase the safety-climate model’s reliability and validity, as well as its model fit.
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Baldziki, Mike; Brown, Jeff; Chan, Hungching; Cheetham, T Craig; Conn, Thomas; Daniel, Gregory W; Hendrickson, Mark; Hilbrich, Lutz; Johnson, Ayanna; Miller, Steven B; Moore, Tom; Motheral, Brenda; Priddy, Sarah A; Raebel, Marsha A; Randhawa, Gurvaneet; Surratt, Penny; Walraven, Cheryl; White, T Jeff; Bruns, Kevin; Carden, Mary Jo; Dragovich, Charlie; Eichelberger, Bernadette; Rosato, Edith; Sega, Todd
2015-01-01
The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will likely provide limited real-world evidence of their effectiveness and safety. How do we best monitor effectiveness and safety of biosimilar products once approved by the FDA and used more extensively by patients? To determine the feasibility of developing a distributed research network that will use health insurance plan and health delivery system data to detect biosimilar safety and effectiveness signals early and be able to answer important managed care pharmacy questions from both the government and managed care organizations. Twenty-one members of the AMCP Task Force on Biosimilar Collective Intelligence Systems met November 12, 2013, to discuss issues involved in designing this consortium and to explore next steps. The task force concluded that a managed care biosimilars research consortium would be of significant value. Task force members agreed that it is best to use a distributed research network structurally similar to existing DARTNet, HMO Research Network, and Mini-Sentinel consortia. However, for some surveillance projects that it undertakes, the task force recognizes it may need supplemental data from managed care and other sources (i.e., a "hybrid" structure model). The task force believes that AMCP is well positioned to lead the biosimilar-monitoring effort and that the next step to developing a biosimilar-innovator collective intelligence system is to convene an advisory council to address organizational governance.
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Klara, Kristina; Kim, Jeanie; Ross, Joseph S
2018-05-01
Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.
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Directory of Open Access Journals (Sweden)
Zhou EH
2017-03-01
Full Text Available Esther H Zhou,1 Sally Seymour,2 Margie R Goulding,1 Elizabeth M Kang,1 Jacqueline M Major,1 Solomon Iyasu1 1Division of Epidemiology, Office of Surveillance and Epidemiology, 2Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA Background: Emerging safety issues associated with long-acting beta2-agonist (LABA have led to multiple regulatory activities by the US Food and Drug Administration (FDA since 2003, including Drug Safety Communications (DSCs in 2010. These DSCs had three specific recommendations for the safe use of LABA products in adult asthma treatment. Methods: We examined the initiation of LABA-containing products for adult asthma treatment using an intermittent time series approach in a claims database from 2003 to 2012. We assessed the alignment of dispensing patterns with the following 2010 FDA recommendations: 1 contraindicated use of single-ingredient (SI-LABA without an asthma controller medication (ACM; 2 a LABA should only be used when asthma is not adequately controlled on inhaled corticosteroids (ICSs or ACM; and 3 step-down asthma therapy (e.g., discontinue LABA when asthma control is achieved. Results: There were 477,922 adults (18–64 years old dispensed a new LABA during 2003–2012. Among LABA initiators, patients who initiated an SI-LABA and who did “not” have an ACM dispensed on the same date decreased from >9% in 2003 (the initial labeling change to <2% post 2010 DSCs (p-value <0.0001 in the segmented regression model. The proportion of asthma patients dispensed an ICS in 6 months prior to initiating LABA treatment did not increase. The proportion of patients with longer than 4 months of continuous treatment did not decrease over the study period. Conclusion: Although the decrease in SI-LABA initiation is consistent with FDA’s recommendations, low ICS dispensing before initiating a LABA and LABA continuation practices require further efforts
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America, you are digging your grave with your spoon--should the FDA tell you that on food labels?
Card, Melissa M
2013-01-01
R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.
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Developing a strong safety culture - a safety management challenge
International Nuclear Information System (INIS)
Low, M.; Gipson, G. P.; Williams, M.
1995-01-01
The approach is presented adapted by Nuclear Electric to build a strong safety culture through the development of its safety management system. Two features regarded as critical to a strong safety culture are: provision of effective communications to promote an awareness and ownership of safety among craft, and commitment to continuous improvement with a genuine willingness to learn from own experiences and those from others. (N.T.) 5 refs., 4 figs., 1 tab
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2011-12-20
... labeling; (2) supply chain issues; and, (3) other issues. FDA may use the information received to develop...? B. Supply Chain Issues 3. What are the supply chain factors (including storage, shipping, and..., or whether the new safety information describes a newly identified risk, or strengthens a risk...
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Kille, Julie; Bungay, Vicky; Oliffe, John; Atchison, Chris
2017-04-13
The capacity to advertise via the Internet continues to contribute to the shifting dynamics in adult commercial sex work. eHealth interventions have shown promise to promote Internet-based sex workers' health and safety internationally, yet minimal attention has been paid in Canada to developing such interventions. Understanding the information communicated in Internet-based sex work advertisements is a critical step in knowledge development to inform such interventions. The purpose of this content analysis was to increase our understanding of the health and safety information within the Internet advertisements among women, men, and transgender sex workers and to describe how this information may be utilized to inform eHealth service development for this population. A total of 75 Internet-based sex worker advertisements (45 women, 24 men, and 6 transgender persons) were purposefully selected from 226 advertisements collected as part of a larger study in Western Canada. Content analysis was employed to guide data extraction about demographic characteristics, sexual services provided, service restrictions, health practices and concerns, safety and security, and business practices. Frequencies for each variable were calculated and further classified by gender. Thematic analysis was then undertaken to situate the communications within the social and commercialized contexts of the sex industry. Four communications themes were identified: (1) demographic characteristics; (2) sexual services; (3) health; and (4) safety and security. White was the most common ethnicity (46/75, 61%) of advertisements. It was found that 20-29 years of age accounted for 32 of the 51 advertisements that provided age. Escort, the only legal business title, was the most common role title used (48/75, 64%). In total, 85% (64/75) of advertisements detailed lists of sexual services provided and 41% (31/75) of advertisements noted never offering uncovered services (ie, no condom). Gender and the
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Stevens, Kathryn J.
1997-01-01
Attempting to incorporate new technology into an existing environment is often very difficult. The problems are lengthy to resolve, wrought with confusion and seldom turn out like anyone expected. This document represents an overview of one such attempt. It outlines the general areas of concern which could be affected by a transition, and potential problems that may be encountered as a result of the effort. Over the past several decades, many local, state and federal agencies are pressing for more efficient use of frequency spectrums. The urgency of this issue has grown due to the demands of several groups wanting access to these channels for commercial use. Pager systems, cellular telephones, radio systems for private businesses all demand more space. Public safety agencies are starting to fear their needs will diminish in importance as the available channel spectrums are consumed by commercial ventures. How to share these channels, purchase appropriate equipment to meet your needs, and stay within a reasonable budget are not easy tasks. Public safety agencies who rely on communication networks in the performance of their jobs also know why encryption is important. Protecting the rights of citizens as police exchange information over the air, maintaining the integrity of an investigation and officer safety are all concerns police must address each time they use a radio.
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Pouwels, Koen; Van Grootheest, Kees
2013-01-01
The rosiglitazone decision process at FDA and EMA. What should we learn? In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone while the FDA decided to restrict its use. These actions were taken because rosiglitazone had been associated with an increased risk of
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Development of Network Protocol for the Integrated Safety System
Energy Technology Data Exchange (ETDEWEB)
Park, S. W.; Baek, J. I.; Lee, S. H.; Park, C. S.; Park, K. H.; Shin, J. M. [Hannam Univ., Daejeon (Korea, Republic of)
2007-06-15
Communication devices in the safety system of nuclear power plants are distinguished from those developed for commercial purposes in terms of a strict requirement of safety. The concept of safety covers the determinability, the reliability, and the separation/isolation to prevent the undesirable interactions among devices. The safety also requires that these properties be never proof less. Most of the current commercialized communication products rarely have the safety properties. Moreover, they can be neither verified nor validated to satisfy the safety property of implementation process. This research proposes the novel architecture and protocol of a data communication network for the safety system in nuclear power plants.
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Development of Network Protocol for the Integrated Safety System
International Nuclear Information System (INIS)
Park, S. W.; Baek, J. I.; Lee, S. H.; Park, C. S.; Park, K. H.; Shin, J. M.
2007-06-01
Communication devices in the safety system of nuclear power plants are distinguished from those developed for commercial purposes in terms of a strict requirement of safety. The concept of safety covers the determinability, the reliability, and the separation/isolation to prevent the undesirable interactions among devices. The safety also requires that these properties be never proof less. Most of the current commercialized communication products rarely have the safety properties. Moreover, they can be neither verified nor validated to satisfy the safety property of implementation process. This research proposes the novel architecture and protocol of a data communication network for the safety system in nuclear power plants
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Reber, K.C.; Piening, S.; Wieringa, J.E.; Straus, S.M.J.M.; Raine, J.M.; de Graeff, Pauline; Haaijer-Ruskamp, F.M.; Mol, Peter G. M.
Serious safety issues relating to drugs are communicated to health-care professionals via Direct Health-Care Professional Communications (DHPCs). We explored which characteristics determined the impact of DHPCs issued in the Netherlands for ambulatory-care drugs (2001-2008). With multiple linear
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Development of Broadband Nuclear Safety Data Network (B-NSDN)
International Nuclear Information System (INIS)
Son, Gwang Seop; Kim, Dong Hoon; Park, Gi Yong
2011-01-01
Recently as introducing digital safety system in nuclear power plant, more data transmission capacity is required. Bandwidth of existing communication network is about a few Mbps. Thus data transmission quantity in recently digital safety system is beyond existing communication network's capacity. In this paper, new protocol that is suitable for safety system communication network is designed. FPGA based communication system is implemented. As result of test, effective bandwidth of B-NSDN is about 20Mbps
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Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?
Rosania, Larry
2010-01-01
Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.
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2010-10-01
... 47 Telecommunication 2 2010-10-01 2010-10-01 false RF safety. 27.52 Section 27.52 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES MISCELLANEOUS WIRELESS COMMUNICATIONS SERVICES Technical Standards § 27.52 RF safety. Licensees and manufacturers are subject to the...
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Alaslai, Nasser Y.
2016-01-05
The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.
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Alaslai, Nasser Y.; Ghanem, Bader; Alghunaimi, Fahd; Litwiller, Eric; Pinnau, Ingo
2016-01-01
The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.
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A Good Year: FDA Approved Nine New Cancer Drugs in 2014
In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.
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Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.
Kesselheim, A S
2010-06-01
In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.
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Velonakis, E; Mantas, J; Mavrikakis, I
2006-01-01
The occupational health and safety management constitutes a field of increasing interest. Institutions in cooperation with enterprises make synchronized efforts to initiate quality management systems to this field. Computer networks can offer such services via TCP/IP which is a reliable protocol for workflow management between enterprises and institutions. A design of such network is based on several factors in order to achieve defined criteria and connectivity with other networks. The network will be consisted of certain nodes responsible to inform executive persons on Occupational Health and Safety. A web database has been planned for inserting and searching documents, for answering and processing questionnaires. The submission of files to a server and the answers to questionnaires through the web help the experts to make corrections and improvements on their activities. Based on the requirements of enterprises we have constructed a web file server. We submit files in purpose users could retrieve the files which need. The access is limited to authorized users and digital watermarks authenticate and protect digital objects. The Health and Safety Management System follows ISO 18001. The implementation of it, through the web site is an aim. The all application is developed and implemented on a pilot basis for the health services sector. It is all ready installed within a hospital, supporting health and safety management among different departments of the hospital and allowing communication through WEB with other hospitals.
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Drozda, Joseph P; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E
2018-02-01
The US Food and Drug Administration (FDA) has recognized the need to improve the tracking of medical device safety and performance, with implementation of Unique Device Identifiers (UDIs) in electronic health information as a key strategy. The FDA funded a demonstration by Mercy Health wherein prototype UDIs were incorporated into its electronic information systems. This report describes the demonstration's informatics architecture. Prototype UDIs for coronary stents were created and implemented across a series of information systems, resulting in UDI-associated data flow from manufacture through point of use to long-term follow-up, with barcode scanning linking clinical data with UDI-associated device attributes. A reference database containing device attributes and the UDI Research and Surveillance Database (UDIR) containing the linked clinical and device information were created, enabling longitudinal assessment of device performance. The demonstration included many stakeholders: multiple Mercy departments, manufacturers, health system partners, the FDA, professional societies, the National Cardiovascular Data Registry, and information system vendors. The resulting system of systems is described in detail, including entities, functions, linkage between the UDIR and proprietary systems using UDIs as the index key, data flow, roles and responsibilities of actors, and the UDIR data model. The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com
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Esterly, John S; Steadman, Emily; Scheetz, Marc H
2011-06-01
In September 2007, the FDA issued an alert recommending that ceftriaxone and calcium-containing solutions should not be administered to any patient within 48 h of each other. Due to the widespread use of ceftriaxone, significant concern was expressed by the greater healthcare community about the warning, which the FDA eventually retracted in April of 2009. We sought to quantify the impact of the warning on healthcare institutions. A survey was administered to the membership of the Society of Infectious Diseases Pharmacists to quantify perceived changes in ceftriaxone use among healthcare institutions across the United States. A survey of Infectious Diseases experts was conducted. Participants were queried for hospital policies/drug use statistics during two times: immediately after the FDA warning and approximately 13 months post warning (preceding the FDA retraction). Related changes in formulary, drug-use policy, and the number of employee hours that were devoted to addressing the FDA warning were assessed. Ninety-four surveys representing 94 hospital systems were included in the analysis. Approximately half (n = 49, 52%) of respondent institutions enacted at least one drug-use policy change based on the warning; one institution removed ceftriaxone from a clinical protocol. Institutions' final interpretations of the warning differed slightly from initial understanding of the warning, and there was an overall minor decrease in the perceived use of ceftriaxone. The majority of those surveyed (n = 70, 74%) estimated that their respective institutions devoted between 1 and 49 employee hours to address the warning. Hospitals with ID pharmacists had minimal changes to ceftriaxone use after the 2007 FDA warning. Specialized pharmacists may be uniquely situated to help hospitals interpret global recommendations locally.
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Raymond, M; Harrison, M C
2014-12-01
Effective communication, co-operation and teamwork have been identified as key determinants of patient safety. SBAR (Situation, Background, Assessment and Recommendation) is a communication tool recommended by the World Health Organization and the UK National Health Service. SBAR is a structured method for communicating critical information that requires immediate attention and action, contributing to effective escalation of management and increased patient safety. To our knowledge, this is the first study showing use of SBAR in South Africa (SA). To determine the effectiveness of adopting the SBAR communication tool in an acute clinical setting in SA. In the first phase of this study, neonatal nurses and doctors at Groote Schuur Hospital, Cape Town, were gathered in a focus group and given a questionnaire asking about communication in the neonatal department. Neonatal nurses and doctors were then trained to use SBAR. A telephone audit demonstrated an increase in SBAR use by registrars from 29% to 70% when calling consultants for help. After training, the majority of staff agreed that SBAR had helped with communication, confidence, and quality of patient care. There was qualitative evidence that SBAR led to greater promptness in care of acutely ill patients. Adopting SBAR was associated with perceived improvement in communication between professionals and in the quality and safety of patient care. It is suggested that this simple tool be introduced to many other hospitals in SA.
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The US FDA and animal cloning: risk and regulatory approach.
Rudenko, Larisa; Matheson, John C
2007-01-01
The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.
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Shurtleff, Amy C; Garza, Nicole; Lackemeyer, Matthew; Carrion, Ricardo; Griffiths, Anthony; Patterson, Jean; Edwin, Samuel S; Bavari, Sina
2012-12-01
We describe herein, limitations on research at biosafety level 4 (BSL-4) containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT) are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP) conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review.
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Directory of Open Access Journals (Sweden)
Jean Patterson
2012-12-01
Full Text Available We describe herein, limitations on research at biosafety level 4 (BSL-4 containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review.
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Shurtleff, Amy C.; Garza, Nicole; Lackemeyer, Matthew; Carrion, Ricardo; Griffiths, Anthony; Patterson, Jean; Edwin, Samuel S.; Bavari, Sina
2012-01-01
We describe herein, limitations on research at biosafety level 4 (BSL-4) containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT) are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP) conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review. PMID:23342380
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2011-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0010] Cooperative Agreement With the World Health Organization Department of Food Safety and Zoonoses in Support of... agreement with the World Health Organization. The document published stating that the total funding...
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2012-05-21
... more authorities to address the increasingly globalized food supply and prevent problems before they... the global supply chain as a key Agency priority. Indeed, two recent reports have focused on the challenges of global supply chains: FDA's ``Pathway to Global Product Safety and Quality,'' and the Institute...
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75 FR 5241 - Maritime Communications
2010-02-02
...] Maritime Communications AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: In this... that its rules governing the Maritime Radio Services continue to promote maritime safety, maximize effective and efficient use of the spectrum available for maritime communications, accommodate technological...
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Farris, April L
2010-01-01
As of 2009, the "natural foods" industry has become a 22.3 billion dollar giant and "all-natural" is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term "natural" through rulemaking. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term "natural," and FDA has abandoned efforts to define "natural" through rulemaking in the face of more pressing priorities. In absence of any governing federal standard, consumer advocacy groups and warring food industries have attempted to define "natural" to fit their preferences through high-stakes litigation of state law claims, leaving courts free to apply diverging standards without the expertise of FDA. Recent case law from federal district courts and the Supreme Court leaves little hope that FDA's current policy statement will preempt state law causes of action. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rulemaking to define the term "natural." This paper concludes by sketching potential formulations for such a rule based on FDA's previous successful rule-making ventures and standards used by natural foods retailers.
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Attacks to Cryptography Protocols of Wireless Industrial Communication Systems
Directory of Open Access Journals (Sweden)
Tomas Ondrasina
2010-01-01
Full Text Available The paper deals with problems of safety and security principles within wireless industrial communication systems. First safety requirements to wireless industrial communication system, summarisation of attack methods and the available measures for risks elimination are described with orientation to safety critical applications. The mainly part is oriented to identification of risks and summarisation of defensive methods of wireless communication based on cryptographic techniques. Practical part the cryptoanalytic’s attacks to COTS (Commercial Off-The-Shelf wireless communications are mentioned based on the IEEE 802.11 standards.
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2010-09-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0394] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01); Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug...
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2010-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice...
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2013-07-29
... Drug Administration 21 CFR Part 1 and 16 Accreditation of Third-Party Auditors/Certification Bodies to... Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue... Administration (FDA) is amending its regulations to provide for accreditation of third-party auditors...
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FDA, CE mark or something else?—Thinking fast and slow
Directory of Open Access Journals (Sweden)
Sundeep Mishra
2017-01-01
Full Text Available There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: “substantial equivalence,” “PMDA,” “CE mark,” “Notified body,” “510K” and “PMA” but the actual approval process can also be very tardy, inconsistent and expensive.
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Directory of Open Access Journals (Sweden)
Kwesi Amponsah-Tawaih
2016-12-01
Conclusion: When employees perceive safety communication, safety systems and training to be positive, they seem to comply with safety rules and procedures than voluntarily participate in safety activities.
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Small Area Estimate Maps: Does the FDA Regulate Tobacco? - Small Area Estimates
This metric is defined as a person 18 years of age or older who must have reported that he/she believes that the United States Food and Drug Administration (FDA) regulates tobacco products in the U.S.
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Gausvik, Christian; Lautar, Ashley; Miller, Lisa; Pallerla, Harini; Schlaudecker, Jeffrey
2015-01-01
Efficient, accurate, and timely communication is required for quality health care and is strongly linked to health care staff job satisfaction. Developing ways to improve communication is key to increasing quality of care, and interdisciplinary care teams allow for improved communication among health care professionals. This study examines the patient- and family-centered use of structured interdisciplinary bedside rounds (SIBR) on an acute care for the elderly (ACE) unit in a 555-bed metropolitan community hospital. This mixed methods study surveyed 24 nurses, therapists, patient care assistants, and social workers to measure perceptions of teamwork, communication, understanding of the plan for the day, safety, efficiency, and job satisfaction. A similar survey was administered to a control group of 38 of the same staff categories on different units in the same hospital. The control group units utilized traditional physician-centric rounding. Significant differences were found in each category between the SIBR staff on the ACE unit and the control staff. Nurse job satisfaction is an important marker of retention and recruitment, and improved communication may be an important aspect of increasing this satisfaction. Furthermore, improved communication is key to maintaining a safe hospital environment with quality patient care. Interdisciplinary team rounds that take place at the bedside improve both nursing satisfaction and related communication markers of quality and safety, and may help to achieve higher nurse retention and safer patient care. These results point to the interconnectedness and dual benefit to both job satisfaction and patient quality of care that can come from enhancements to team communication.
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Flohr, Luisa; Beaudry, Shaylene; Johnson, K Taneille; West, Nicholas; Burns, Catherine M; Ansermino, J Mark; Dumont, Guy A; Wensley, David; Skippen, Peter
2018-01-01
The pediatric intensive care unit (ICU) is a complex environment, in which a multidisciplinary team of clinicians (registered nurses, respiratory therapists, and physicians) continually observe and evaluate patient information. Data are provided by multiple, and often physically separated sources, cognitive workload is high, and team communication can be challenging. Our aim is to combine information from multiple monitoring and therapeutic devices in a mobile application, the VitalPAD, to improve the efficiency of clinical decision-making, communication, and thereby patient safety. We observed individual ICU clinicians, multidisciplinary rounds, and handover procedures for 54 h to identify data needs, workflow, and existing cognitive aid use and limitations. A prototype was developed using an iterative participatory design approach; usability testing, including general and task-specific feedback, was obtained from 15 clinicians. Features included map overviews of the ICU showing clinician assignment, patient status, and respiratory support; patient vital signs; a photo-documentation option for arterial blood gas results; and team communication and reminder functions. Clinicians reported the prototype to be an intuitive display of vital parameters and relevant alerts and reminders, as well as a user-friendly communication tool. Future work includes implementation of a prototype, which will be evaluated under simulation and real-world conditions, with the aim of providing ICU staff with a monitoring device that will improve their daily work, communication, and decision-making capacity. Mobile monitoring of vital signs and therapy parameters might help improve patient safety in wards with single-patient rooms and likely has applications in many acute and critical care settings. PMID:29552425
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FDA approves efavirenz. Food and Drug Administration.
Highleyman, L
1998-10-01
The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.
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Abdulhamid, Mahmoud A.
2017-10-12
A newly designed carbocyclic pseudo Tröger\\'s base diamine (CTB) monomer, 2,8-dimethyl-3,9-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (CTBDA) and its isomeric analogue 2,8-dimethyl-(1,7)(4,10)(3,9)-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (iCTBDA), were designed for the synthesis of microporous 6FDA-based polyimides (6FDA-CTBDA and 6FDA-iCTBDA). Both polyimides were soluble, exhibited excellent thermal stability of ∼490 °C, and had high surface areas of 587 m2 g−1 (6FDA-CTBDA) and 562 m2 g−1 (6FDA-iCTBDA). A 6FDA-based polyimide derived from 4,10-dimethyl-3,9-diamino-6H,12H-5,11-methanodibenzo[b,f][1,5]-diazocine (6FDA-TBDA) was made for comparison to investigate the effects of the basic tertiary nitrogen functionality in the Tröger\\'s base diamine on the polymer properties relative to the carbocyclic 6FDA-CTBDA analogue. 6FDA-TBDA displayed lower gas permeabilities but moderately higher gas-pair permselectivities than 6FDA-CTBDA. The enhanced permselectivity of 6FDA-TBDA resulted exclusively from higher diffusion-based selectivity. Direct gas sorption measurements demonstrated that the basicity in the Tröger\\'s base bridge moiety enhanced the sorption capacity of CO2 only slightly and had no effect on the CO2/CH4 solubility selectivity in 6FDA-TBDA vs. 6FDA-CTBDA.
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1999-05-14
The Food and Drug Administration (FDA) is announcing the availability of a new compliance policy guide (CPG) entitled "Year 2000 (Y2K) Computer Compliance" (section 160-800). This guidance document represents the agency's current thinking on the manufacturing and distribution of domestic and imported products regulated by FDA using computer systems that may not perform properly before, or during, the transition to the year 2000 (Y2K). The text of the CPG is included in this notice. This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG, and it will be included in the next printing of the Compliance Policy Guides Manual. This CPG is intended for FDA personnel, and it is available electronically to the public.
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Mackey, Tim K
2012-01-01
Background Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. Objective To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. Methods We performed a descriptive study of the prevalence of online marketing for shortage drugs—that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Results Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. Conclusions FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing. PMID:22321731
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Liang, Bryan A; Mackey, Tim K
2012-02-09
Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. We performed a descriptive study of the prevalence of online marketing for shortage drugs-that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing.
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DEFF Research Database (Denmark)
Jørgensen, Poul-Erik; Eriksen, T.; Jensen, B.K.
1992-01-01
ATP content, oxygen utilization rate (OUR) and fluorescein diacetate (FDA) hydrolysis were tested for the ability to express the amount of viable biomass in wastewater and activated sludge. The relationship between biomass and these activity parameters was established in growth cultures made...... with biomass, while FDA hydrolysis in the sludge failed to show any such correlation. Conversion factors of 3 mg ATP/g dw, 300 mg O2/h g dw and 0.4 A/h (mg dw/ml) for ATP, OUR and FDA methods, respectively, were calculated. When the methods were applied for in situ determinations in four different wastewater...... plants, it was found that ATP content and respiration rate estimated viable biomass to range from 81 to 293 mg dw/g SS for raw wastewater and from 67 to 187 mg dw/g SS for activated sludge with a rather weak correlation between ATP and respiration measurements. The FDA hydrolysis estimated viable biomass...
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Small is Beautiful? Firm's Size, Prevention & Food Safety.
Rouviere, Elodie; Soubeyran, Raphael
2012-01-01
The European General Food Law of 2005 and the newly promulgated FDA Food Safety Modernization Act (FFSMA) of 2010 ask all food operators to implement preventive efforts. In this article, we explore the link between firm’s size and preventive efforts. We show two main results. First, when there is no cross-contamination, small firms will provide higher preventive efforts than large firms. When there is crosscontamination, the effort-size curve may have a "inverted-U" shape. From our results we...
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Nields, Morgan W
2010-05-01
Digital mammography is routinely used in the US to screen asymptomatic women for breast cancer and currently over 50% of US screening centers employ the technology. In spite of FDAs knowledge that digital mammography requires less radiation than film mammography and that its equivalence has been proven in a prospective randomized trial, the agency has failed to allow the technology market access via the 510(k) pre market clearance pathway. As a result of the restrictive Pre Market Approval process, only four suppliers have received FDA approval. The resulting lack of a competitive market has kept costs high, restricted technological innovation, and impeded product improvements as a result of PMA requirements. Meanwhile, at least twelve companies are on the market in the EU and the resulting competitive market has lowered costs and provided increased technological choice. A cultural change with new leadership occurred in the early 90's at FDA. The historical culture at the Center for Devices and Radiological Health of collaboration and education gave way to one characterized by a lack of reliance on outside scientific expertise, tolerance of decision making by unqualified reviewers, and an emphasis on enforcement and punishment. Digital mammography fell victim to this cultural change and as a result major innovations like breast CT and computer aided detection technologies are also withheld from the market. The medical device law, currently under review by the Institute of Medicine, should be amended by the Congress so that new technologies can be appropriately classified in accordance with the risk based assessment classification system detailed in Chapter V of the Federal Food, Drug, and Cosmetic Act. A panel of scientific experts chartered by the NIH or IOM should determine the classification appropriate for new technologies that have no historical regulatory framework. This would be binding on FDA. Unless the law is changed we will likely again experience
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FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR Staging
An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing. Br
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2011-04-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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Hess, George; Peterson, M Nils
2015-01-01
Many global challenges, including obesity, health care costs, and climate change, could be addressed in part by increasing the use of bicycles for transportation. Concern about the safety of bicycling on roadways is frequently cited as a deterrent to increasing bicycle use in the USA. The use of effective signage along roadways might help alleviate these concerns by increasing knowledge about the rights and duties of bicyclists and motorists, ideally reducing crashes. We administered a web-based survey, using Twitter for recruitment, to examine how well three US traffic control devices communicated the message that bicyclists are permitted in the center of the travel lane and do not have to "get out of the way" to allow motorists to pass without changing lanes: "Bicycles May Use Full Lane" and "Share the Road" signage, and Shared Lane Markings on the pavement. Each was compared to an unsigned roadway. We also asked respondents whether it was safe for a bicyclist to occupy the center of the travel lane. "Bicycles May Use Full Lane" signage was the most consistently comprehended device for communicating the message that bicyclists may occupy the travel lane and also increased perceptions of safety. "Share the Road" signage did not increase comprehension or perceptions of safety. Shared Lane Markings fell somewhere between. "Bicycles May Use Full Lane" signage showed notable increases in comprehension among novice bicyclists and private motor vehicle commuters, critical target audiences for efforts to promote bicycling in the USA. Although limited in scope, our survey results are indicative and suggest that Departments of Transportation consider replacing "Share the Road" with "Bicycles May Use Full Lane" signage, possibly combined with Shared Lane Markings, if the intent is to increase awareness of roadway rights and responsibilities. Further evaluation through virtual reality simulations and on-road experiments is merited.
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Directory of Open Access Journals (Sweden)
George Hess
Full Text Available Many global challenges, including obesity, health care costs, and climate change, could be addressed in part by increasing the use of bicycles for transportation. Concern about the safety of bicycling on roadways is frequently cited as a deterrent to increasing bicycle use in the USA. The use of effective signage along roadways might help alleviate these concerns by increasing knowledge about the rights and duties of bicyclists and motorists, ideally reducing crashes. We administered a web-based survey, using Twitter for recruitment, to examine how well three US traffic control devices communicated the message that bicyclists are permitted in the center of the travel lane and do not have to "get out of the way" to allow motorists to pass without changing lanes: "Bicycles May Use Full Lane" and "Share the Road" signage, and Shared Lane Markings on the pavement. Each was compared to an unsigned roadway. We also asked respondents whether it was safe for a bicyclist to occupy the center of the travel lane. "Bicycles May Use Full Lane" signage was the most consistently comprehended device for communicating the message that bicyclists may occupy the travel lane and also increased perceptions of safety. "Share the Road" signage did not increase comprehension or perceptions of safety. Shared Lane Markings fell somewhere between. "Bicycles May Use Full Lane" signage showed notable increases in comprehension among novice bicyclists and private motor vehicle commuters, critical target audiences for efforts to promote bicycling in the USA. Although limited in scope, our survey results are indicative and suggest that Departments of Transportation consider replacing "Share the Road" with "Bicycles May Use Full Lane" signage, possibly combined with Shared Lane Markings, if the intent is to increase awareness of roadway rights and responsibilities. Further evaluation through virtual reality simulations and on-road experiments is merited.
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2011-10-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0733] Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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Final Safety Assessment of Coal Tar as Used in Cosmetics
Energy Technology Data Exchange (ETDEWEB)
NONE
2008-07-01
Coal Tar is a semisolid by-product obtained in the destructive distillation of bituminous coal, which functions in cosmetic products as a cosmetic biocide and denaturant-antidandruff agent is also listed as a function, but this is considered an over-the-counter (OTC) drug use. In 2002, Coal Tar was reported to the Food and Drug Administration (FDA) to be used in four formulations, all of which appear to be OTC drug products. Coal Tar is monographed by the FDA as Category I (safe and effective) OTC drug ingredient for use in the treatment of dandruff, seborrhoea, and psoriasis. Coal Tar is absorbed through the skin of animals and humans and is systemically distributed. Although the Cosmetic Ingredient Review (CIR) Expert Panel believes that Coal Tar use as an antidandruff ingredient in OTC drug preparations is adequately addressed by the FDA regulations, the Panel also believes that the appropriate concentration of use of Coal Tar in cosmetic formulations should be that level that does not have a biological effect in the user. Additional data needed to make a safety assessment include product types in which Coal Tar is used (other than as an OTC drug ingredient), use concentrations, and the maximum concentration that does not induce a biological effect in users.
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49 CFR 193.2519 - Communication systems.
2010-10-01
...: FEDERAL SAFETY STANDARDS Operations § 193.2519 Communication systems. (a) Each LNG plant must have a primary communication system that provides for verbal communications between all operating personnel at... 49 Transportation 3 2010-10-01 2010-10-01 false Communication systems. 193.2519 Section 193.2519...
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Current and future state of FDA-CMS parallel reviews.
Messner, D A; Tunis, S R
2012-03-01
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians.
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Impact of biomarker development on drug safety assessment
International Nuclear Information System (INIS)
Marrer, Estelle; Dieterle, Frank
2010-01-01
Drug safety has always been a key aspect of drug development. Recently, the Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide the clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on safety biomarker development. An illustrative and 'door opening' safety biomarker success story is the recent recognition of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the 'know how' acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e., molecular pathology as a complement to the classical toolbox, allow promising discoveries in the safety biomarker field. This review will focus on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example.
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Language and Nutrition (Mis)Information: Food Labels, FDA Policies and Meaning
Taylor, Christy Marie
2013-01-01
In this dissertation, I address the ways in which food manufacturers can exploit the often vague and ambiguous nature of FDA policies concerning language and images used on food labels. Employing qualitative analysis methods (Strauss, 1987; Denzin and Lincoln, 2003; Mackey and Gass, 2005) that drew upon critical discourse analysis (Fairclough,…
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21 CFR 14.15 - Committees working under a contract with FDA.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... committee: (1) The committee shall give public notice of its meetings and agenda, and provide interested...
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FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR
The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer In
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The rosiglitazone decision process at FDA and EMA : What should we learn?
Pouwels, Koen B.; van Grootheest, Kees
2012-01-01
In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased
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International Nuclear Information System (INIS)
Espinosa V, J. M.
2012-10-01
The Comision Nacional de Seguridad Nuclear y Salvaguardias (CNSNS) in use of their attributions granted by the Regulation Law of the constitutional Art. 27 in nuclear matter began the development of the called process External communications on the nuclear facilities operation, with the purpose of negotiating the evaluation of the concerns related with the safety of the nuclear facilities received these of external people to the CNSNS. The process External communications on the nuclear facilities operation will allow to the public's members and the workers that carry out activities inside the mark regulator imposed by the CNSNS that report to this Commission their concerns related with safety for several means (for example, directly to the personnel of the assigned Office, official and public statements, phone communication, electronic mail, etc.) The present article presents the legal mark confers the CNSNS the attributions to develop the mentioned process and exposes the most important elements that compose it. The term External communication on the nuclear facilities operation is defined and also is described how these communications are received, evaluated and closed by the assigned Office. Of equal way the objectives that intents to reach this process are indicated. The intention of the mentioned process is to strengthen the actions that the CNSNS carries out in the execution of its functions to maintain the safety standards in the operation of the nuclear facilities in Mexico. (Author)
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... visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to ... Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone ( ...
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... visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to ... Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone ( ...
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A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus.
Ekins, Sean; Freundlich, Joel S; Coffee, Megan
2014-01-01
We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.
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A Comprehensive Review of US FDA-Approved Immune Checkpoint Inhibitors in Urothelial Carcinoma
Directory of Open Access Journals (Sweden)
Fu-Shun Hsu
2017-01-01
Full Text Available Few effective treatment options are available for patients with advanced or metastatic urothelial carcinoma (UC after unsuccessful first-line platinum-based chemotherapy. To date, immune checkpoint inhibitors are novel therapeutic agents for UC treatment. From May 2016 to May 2017, five anti-PD-1/PD-L1 monoclonal antibodies received accelerated or regular approval from the US Food and Drug Administration (FDA for the treatment of patients with locally advanced or metastatic UC. The present comprehensive review presents the background information of these five US FDA-approved anticancer agents to provide a basic but concise understanding of these agents for advanced studies. We summarize their immune checkpoint mechanisms, clinical efficacy, recommended usage protocols, adverse events, and the limitations of the PD-L1 biomarker assays.
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Can we use IEC 61850 for safety related functions?
Directory of Open Access Journals (Sweden)
Luca Rocca
2016-08-01
Full Text Available Safety is an essential issue for processes that present high risk for human beings and environment. An acceptable level of risk is obtained both with actions on the process itself (risk reduction and with the use of special safety systems that switch the process into safe mode when a fault or an abnormal operation mode happens. These safety systems are today based on digital devices that communicate through digital networks. The IEC 61508 series specifies the safety requirements of all the devices that are involved in a safety function, including the communication network. Also electrical generation and distribution systems are processes that may have a significant level of risk, so the criteria stated by the IEC 61508 applies. Starting from this consideration, the paper analyzes the safety requirement for the communication network and compare them with the services of the communication protocol IEC 61850 that represents the most used protocol for automation of electrical plants. The goal of this job is to demonstrate that, from the technical point of view, IEC 61850 can be used for implementing safety-related functions, even if a formal safety certification is still missing.
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International Nuclear Information System (INIS)
Denney, Bruce
1989-01-01
Full text: A review of the Food and Drug Administration's (FDA) rationale and methods for determining protective action guidelines (PAGs) and derived response levels (DRLs) (FDAa82, FDAb82) for human food and animal feed reveals the presence of ambiguous and contradictory information that should be clarified in order to improve the usefulness of the guidance. The differences in the criteria used to determine the Preventative and Emergency PAGs and DRLs, for example, are striking. The Preventative PAGs (and DRLs) are based on accepted health physics principles, e.g. risk factors, avoidance of fetal health effects, agricultural models, etc. The Emergency PAGs (and DRLs), however, are based solely on a traditional safety factor of ten. This difference in rationale becomes more conspicuous when the protective actions for these PAGs are compared: preventative protective actions involve low impact actions, e.g. removal of cattle from pasture, storage to allow for radioactive decay, etc., while emergency protective actions involve high impact actions e.g. isolating and condemning food products. These differences result in a contradiction: high impact actions, which may cause considerable problems and loss of income for farmers and food processors, are based on non-technical premises ('tradition'), while the low impact actions, which may only result in minor inconveniences to farmers and food processors, are based on solid scientific principles. Justifying or explaining these differences to farmers or to the media may be very difficult. Clearly there exists a need to review the basis and rationale upon which the Emergency PAGs and DRLs were derived in order to provide a more scientific explanation for their choice and use. In the FDA guidance (FDAa82), references are also made to ALARA and to the use of low-impact actions at doses lower than the PAGs. Although the FDA accepts and endorses the concept of keeping doses as low as reasonably achievable, the FDA does not
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Evaluation and Customization of WHO Safety Checklist for Patient Safety in Otorhinolaryngology.
Dabholkar, Yogesh; Velankar, Haritosh; Suryanarayan, Sneha; Dabholkar, Twinkle Y; Saberwal, Akanksha A; Verma, Bhavika
2018-03-01
The WHO has designed a safe surgery checklist to enhance communication and awareness of patient safety during surgery and to minimise complications. WHO recommends that the check-list be evaluated and customised by end users as a tool to promote safe surgery. The aim of present study was to evaluate the impact of WHO safety checklist on patient safety awareness in otorhinolaryngology and to customise it for the speciality. A prospective structured questionnaire based study was done in ENT operating room for duration of 1 month each for cases, before and after implementation of safe surgery checklist. The feedback from respondents (surgeons, nurses and anaesthetists) was used to arrive at a customised checklist for otolaryngology as per WHO guidelines. The checklist significantly improved team member's awareness of patient's identity (from 17 to 86%) and each other's identity and roles (from 46 to 94%) and improved team communication (from 73 to 92%) in operation theatre. There was a significant improvement in preoperative check of equipment and critical events were discussed more frequently. The checklist could be effectively customised to suit otolaryngology needs as per WHO guidelines. The modified checklist needs to be validated by otolaryngology associations. We conclude from our study that the WHO Surgical safety check-list has a favourable impact on patient safety awareness, team-work and communication of operating team and can be customised for otolaryngology setting.
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Communications and Information Sharing (CIS) Laboratory
Federal Laboratory Consortium — TheCommunications and Information Sharing (CIS) Laboratory is a Public Safety interoperable communications technology laboratory with analog and digital radios, and...
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Directory of Open Access Journals (Sweden)
Hyosun Kim
2015-12-01
Full Text Available Background For the purpose of understanding the Food and Drug Administration’s (FDA’s concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs and warning letters issued by the FDA to pharmaceutical manufacturers. Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014 regarding online promotional activities, were content-analyzed. Results Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Conclusion Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the
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Digital, Satellite-Based Aeronautical Communication
Davarian, F.
1989-01-01
Satellite system relays communication between aircraft and stations on ground. System offers better coverage with direct communication between air and ground, costs less and makes possible new communication services. Carries both voice and data. Because many data exchanged between aircraft and ground contain safety-related information, probability of bit errors essential.
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2017-11-22
This final rule adopts without changes an interim final rule with request for comments published in the Federal Register on March 23, 2017. On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. The Drug Enforcement Administration (DEA) maintains FDA-approved products of oral solutions containing dronabinol in schedule II of the Controlled Substances Act.
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Energy Technology Data Exchange (ETDEWEB)
Drottz-Sjoeberg, Britt-Marie [Norwegian Univ. of Science and Technology, NTNU, Trondheim (Norway). Dept. of Psychology
2001-07-01
The paper presents results from the 'Communication 2000' project within the Nordic Nuclear Safety Research (NKS) framework which aimed at developing methods as well as knowledge related to problems in risk communication. Focus groups and questionnaires were used to explicitly pinpoint the problems encountered when informing about or discussing risk and technologically advanced information (e.g. PSA-results) relative the public and across professional groups with different types of expertise. Personnel at a nuclear power plant and politicians of a local safety board provided their views of essential communication problems related to their work tasks in focus group discussions. Central topics that emerged from these discussions were later used in a questionnaire study, distributed to similar groups of power plant personnel, and politicians and administrators, in the local community. Some results are presented, together with a comparison of the two modes of investigating what is problematic in risk communication (e.g. focus groups vs. questionnaires). The difficulties involved in establishing a similar understanding of a phenomenon is addressed in the discussion.
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International Nuclear Information System (INIS)
Drottz-Sjoeberg, Britt-Marie
2001-01-01
The paper presents results from the 'Communication 2000' project within the Nordic Nuclear Safety Research (NKS) framework which aimed at developing methods as well as knowledge related to problems in risk communication. Focus groups and questionnaires were used to explicitly pinpoint the problems encountered when informing about or discussing risk and technologically advanced information (e.g. PSA-results) relative the public and across professional groups with different types of expertise. Personnel at a nuclear power plant and politicians of a local safety board provided their views of essential communication problems related to their work tasks in focus group discussions. Central topics that emerged from these discussions were later used in a questionnaire study, distributed to similar groups of power plant personnel, and politicians and administrators, in the local community. Some results are presented, together with a comparison of the two modes of investigating what is problematic in risk communication (e.g. focus groups vs. questionnaires). The difficulties involved in establishing a similar understanding of a phenomenon is addressed in the discussion
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Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.
Serabian, M A; Pilaro, A M
1999-01-01
Many scientific discussions, especially in the past 8 yr, have focused on definition of criteria for the optimal assessment of the preclinical toxicity of pharmaceuticals. With the current overlap of responsibility among centers within the Food and Drug Administration (FDA), uniformity of testing standards, when appropriate, would be desirable. These discussions have extended beyond the boundaries of the FDA and have culminated in the acceptance of formalized, internationally recognized guidances. The work of the International Committee on Harmonisation (ICH) and the initiatives developed by the FDA are important because they (a) represent a consensus scientific opinion, (b) promote consistency, (c) improve the quality of the studies performed, (d) assist the public sector in determining what may be generally acceptable to prepare product development plans, and (e) provide guidance for the sponsors in the design of preclinical toxicity studies. Disadvantages associated with such initiatives include (a) the establishment of a historical database that is difficult to relinquish, (b) the promotion of a check-the-box approach, i.e., a tendancy to perform only the minimum evaluation required by the guidelines, (c) the creation of a disincentive for industry to develop and validate new models, and (d) the creation of state-of-the-art guidances that may not allow for appropriate evaluation of novel therapies. The introduction of biotechnology-derived pharmaceuticals for clinical use has often required the application of unique approaches to assessing their safety in preclinical studies. There is much diversity among these products, which include the gene and cellular therapies, monoclonal antibodies, human-derived recombinant regulatory proteins, blood products, and vaccines. For many of the biological therapies, there will be unique product issues that may require specific modifications to protocol design and may raise additional safety concerns (e.g., immunogenicity
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The need for strategic development of safety sciences.
Busquet, Francois; Hartung, Thomas
2017-01-01
The practice of risk assessment and regulation of substances has largely developed as a patchwork of circumstantial additions to a nowadays more or less shared international toolbox. The dominant drivers from the US and Europe have pursued remarkably different approaches in the use of these tools for regulation, i.e., a more risk-based approach in the US and a more precautionary approach in Europe. We argue that there is need for scientific developments not only for the tools but also for their application, i.e., a need for Regulatory Science or, perhaps better, Safety Science. While some of this is emerging on the US side as strategic reports, e.g., from the National Academies, the NIH and the regulatory agencies, especially the EPA and the FDA, such strategic developments beyond technological developments are largely lacking in Europe or have started only recently at EFSA, ECHA or within the flagship project EU-ToxRisk. This article provides a rationale for the creation of a European Safety Sciences Institute (ESSI) based on regulatory and scientific needs, political context and current EU missions. Moreover, the possible modus operandi of ESSI will be described along with possible working formats as well as anticipated main tasks and duties. This mirrors the triple alliance on the American side (US EPA, NIH and FDA) in revamping regulatory sciences. Moreover, this could fit the political agenda of the European Commission for better implementation of existing EU legislation rather than creating new laws.
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Tucker, Sean; Chmiel, Nik; Turner, Nick; Hershcovis, M Sandy; Stride, Chris B
2008-10-01
In the present study, we modeled 2 sources of safety support (perceived organizational support for safety and perceived coworker support for safety) as predictors of employee safety voice, that is, speaking out in an attempt to change unsafe working conditions. Drawing on social exchange and social impact theories, we hypothesized and tested a mediated model predicting employee safety voice using a cross-sectional survey of urban bus drivers (n = 213) in the United Kingdom. Hierarchical regression analysis showed that perceived coworker support for safety fully mediated the relationship between perceived organizational support for safety and employee safety voice. This study adds to the employee voice literature by evaluating the important role that coworkers can play in encouraging others to speak out about safety issues. Implications for research and practice related to change-oriented safety communication are discussed.
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Davenport, Daniel L; Henderson, William G; Mosca, Cecilia L; Khuri, Shukri F; Mentzer, Robert M
2007-12-01
Since the Institute of Medicine patient safety reports, a number of survey-based measures of organizational climate safety factors (OCSFs) have been developed. The goal of this study was to measure the impact of OCSFs on risk-adjusted surgical morbidity and mortality. Surveys were administered to staff on general/vascular surgery services during a year. Surveys included multiitem scales measuring OCSFs. Additionally, perceived levels of communication and collaboration with coworkers were assessed. The National Surgical Quality Improvement Program was used to assess risk-adjusted morbidity and mortality. Correlations between outcomes and OCSFs were calculated and between outcomes and communication/collaboration with attending and resident doctors, nurses, and other providers. Fifty-two sites participated in the survey: 44 Veterans Affairs and 8 academic medical centers. A total of 6,083 surveys were returned, for a response rate of 52%. The OCSF measures of teamwork climate, safety climate, working conditions, recognition of stress effects, job satisfaction, and burnout demonstrated internal validity but did not correlate with risk-adjusted outcomes. Reported levels of communication/collaboration with attending and resident doctors correlated with risk-adjusted morbidity. Survey-based teamwork, safety climate, and working conditions scales are not confirmed to measure organizational factors that influence risk-adjusted surgical outcomes. Reported communication/collaboration with attending and resident doctors on surgical services influenced patient morbidity. This suggests the importance of doctors' coordination and decision-making roles on surgical teams in providing high-quality and safe care. We propose risk-adjusted morbidity as an effective measure of surgical patient safety.
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2010-12-20
... Environmental Protection Agency. FDA received a comment relating to the cruelty and sadism of animal testing. In... Request; Testing Communications on FDA-Regulated Products Used in Animals AGENCY: Food and Drug... Communications on FDA-Regulated Products Used in Animals.'' Also include the FDA docket number found in brackets...
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Li, Chunfeng; Zhu, Xingliang; Ji, Xue; Quanquin, Natalie; Deng, Yong-Qiang; Tian, Min; Aliyari, Roghiyh; Zuo, Xiangyang; Yuan, Ling; Afridi, Shabbir Khan; Li, Xiao-Feng; Jung, Jae U; Nielsen-Saines, Karin; Qin, Frank Xiao-Feng; Qin, Cheng-Feng; Xu, Zhiheng; Cheng, Genhong
2017-10-01
Zika virus (ZIKV) has become a global public health emergency due to its rapidly expanding range and its ability to cause severe congenital defects such as microcephaly. However, there are no FDA-approved therapies or vaccines against ZIKV infection. Through our screening of viral entry inhibitors, we found that chloroquine (CQ), a commonly used antimalarial and a FDA-approved drug that has also been repurposed against other pathogens, could significantly inhibit ZIKV infection in vitro, by blocking virus internalization. We also demonstrated that CQ attenuates ZIKV-associated morbidity and mortality in mice. Finally, we proved that CQ protects fetal mice from microcephaly caused by ZIKV infection. Our methodology of focusing on previously identified antivirals in screens for effectiveness against ZIKV proved to be a rapid and efficient means of discovering new ZIKV therapeutics. Selecting drugs that were previously FDA-approved, such as CQ, also improves the likelihood that they may more quickly reach stages of clinical testing and use by the public. Copyright © 2017. Published by Elsevier B.V.
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21 CFR 111.610 - What records must be made available to FDA?
2010-04-01
... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...
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Integration of new technology into clinical practice after FDA approval.
Govil, Ashul; Hao, Steven C
2016-10-01
Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.
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2015-01-01
Many global challenges, including obesity, health care costs, and climate change, could be addressed in part by increasing the use of bicycles for transportation. Concern about the safety of bicycling on roadways is frequently cited as a deterrent to increasing bicycle use in the USA. The use of effective signage along roadways might help alleviate these concerns by increasing knowledge about the rights and duties of bicyclists and motorists, ideally reducing crashes. We administered a web-based survey, using Twitter for recruitment, to examine how well three US traffic control devices communicated the message that bicyclists are permitted in the center of the travel lane and do not have to “get out of the way” to allow motorists to pass without changing lanes: “Bicycles May Use Full Lane” and “Share the Road” signage, and Shared Lane Markings on the pavement. Each was compared to an unsigned roadway. We also asked respondents whether it was safe for a bicyclist to occupy the center of the travel lane. “Bicycles May Use Full Lane” signage was the most consistently comprehended device for communicating the message that bicyclists may occupy the travel lane and also increased perceptions of safety. “Share the Road” signage did not increase comprehension or perceptions of safety. Shared Lane Markings fell somewhere between. “Bicycles May Use Full Lane” signage showed notable increases in comprehension among novice bicyclists and private motor vehicle commuters, critical target audiences for efforts to promote bicycling in the USA. Although limited in scope, our survey results are indicative and suggest that Departments of Transportation consider replacing “Share the Road” with “Bicycles May Use Full Lane” signage, possibly combined with Shared Lane Markings, if the intent is to increase awareness of roadway rights and responsibilities. Further evaluation through virtual reality simulations and on-road experiments is merited. PMID
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Stem-cell-derived products: an FDA update.
Moos, Malcolm
2008-12-01
The therapeutic potential of products derived from stem cells of various types has prompted increasing research and development and public attention. Initiation of human clinical trials in the not-too-distant future is now a realistic possibility. It is, therefore, important to weigh the potential benefits against known, theoretical and totally unsuspected risks in light of current knowledge to ensure that subjects participating in these trials are afforded the most reasonable balance possible between potential risks and potential benefits. There are no apparent differences in fundamental, qualitative biological characteristics between stem-cell-derived products and other cellular therapies regulated by the United States Food and Drug Administration (FDA). Existing authorities can, therefore, be applied. Nevertheless, these products do have properties that require careful evaluation.
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Safety regulation KTA 3901: Communication systems for nuclear power plants
International Nuclear Information System (INIS)
1981-01-01
The regulation applies to communication systems in stationary nuclear power plants with at least one power plant unit, i.e. alarm systems, staff locator systems, communicators, and systems for external communication. The regulation determines the type and extent of staff communication systems as well as the demands to be made on layout, installation, operating systems, and testing of communication systems for nuclear power plants. (orig./HP) [de
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2013-08-22
... information submitted to FDA is available to all interested persons in a timely fashion. DATES: Submit... completeness and quality of analyses of data on demographic subgroups in summaries of product safety and... product types and applicability. The action plan is due not later than 1 year after the publication of the...
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2010-11-22
... Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0571] Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and the Use of...
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[Communication Test for Foreign Physicians in Germany: The Patient Communication Test].
Farhan, N; Leonhart, R; Puffe, L; Boeker, M; Wirsching, M
2016-04-01
The number of foreign doctors in Germany has increased steadily in recent years. To obtain the German medical license, sufficient language competence is mandatory. Nevertheless, in practice, foreign doctors have considerable difficulties in their communication with patients, medical colleagues and other health professionals. This can lead to misunderstandings and thus impair patient safety. To overcome this problem, the "patient communication test" was developed and piloted as an additional requirement to be granted license to practice medicine in Germany. The aim of this study is to present our results in the development and piloting of this test. 3 OSCE stations (Objective Structured Clinical Examination) were designed, which evaluate communication skills in 3 medical competences: history taking, case presentation and explaining to patients before obtaining informed consent. After extensive instruction of actors as patients and raters on the basis of the evaluation criteria, the communication test was subjected to pilot studies in 6 different cities (Freiburg, Jena, Mainz, Mannheim, Tübingen, and Ulm). In 2013, 639 foreign doctors participated in the test; 461 (72.14%) of these doctors passed the test on their first try, 51 (7.98%) on their second attempt and 6 (0.93%) on their third try. The patient communication test evaluates the communication skills of foreign doctors in OSCE-setting using standardized actor-patients. This improves the communication skills and enhances patient safety in the German health care system by smooth inter-professional and patient-centered communication. © Georg Thieme Verlag KG Stuttgart · New York.
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Automatic extraction of drug indications from FDA drug labels.
Khare, Ritu; Wei, Chih-Hsuan; Lu, Zhiyong
2014-01-01
Extracting computable indications, i.e. drug-disease treatment relationships, from narrative drug resources is the key for building a gold standard drug indication repository. The two steps to the extraction problem are disease named-entity recognition (NER) to identify disease mentions from a free-text description and disease classification to distinguish indications from other disease mentions in the description. While there exist many tools for disease NER, disease classification is mostly achieved through human annotations. For example, we recently resorted to human annotations to prepare a corpus, LabeledIn, capturing structured indications from the drug labels submitted to FDA by pharmaceutical companies. In this study, we present an automatic end-to-end framework to extract structured and normalized indications from FDA drug labels. In addition to automatic disease NER, a key component of our framework is a machine learning method that is trained on the LabeledIn corpus to classify the NER-computed disease mentions as "indication vs. non-indication." Through experiments with 500 drug labels, our end-to-end system delivered 86.3% F1-measure in drug indication extraction, with 17% improvement over baseline. Further analysis shows that the indication classifier delivers a performance comparable to human experts and that the remaining errors are mostly due to disease NER (more than 50%). Given its performance, we conclude that our end-to-end approach has the potential to significantly reduce human annotation costs.
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FDA regulations regarding iodine addition to foods and labeling of foods containing added iodine12
Trumbo, Paula R
2016-01-01
The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, “This salt does not supply iodide, a necessary nutrient.” If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine. PMID:27534626
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1998-11-18
The Food and Drug Administration (FDA) published in the Federal Register of August 7, 1998 (63 FR 42229), a direct final rule. The direct final rule notified the public of FDA's intention to amend the regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. This document delays the effective date of the direct final rule.
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Risk assessment terminology: risk communication part 1
Directory of Open Access Journals (Sweden)
Gaetano Liuzzo
2016-03-01
Full Text Available The paper describes the terminology of risk communication in the view of food safety: the theory of stakeholders, the citizens’ involvement and the community interest and consultation are reported. Different aspects of risk communication (public communication, scientific uncertainty, trust, care, consensus and crisis communication are discussed.
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FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR Staging
The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer In
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14 CFR 431.41 - Communications plan.
2010-01-01
... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Communications plan. 431.41 Section 431.41... Launch and Reentry of a Reusable Launch Vehicle § 431.41 Communications plan. (a) An applicant shall submit a plan providing vehicle safety operations personnel communications procedures during the mission...
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Risk Perception, Communication and Food Safety
Frewer, L.J.
2011-01-01
Developing an effective communication strategy about different food hazards depends not only on technical risk assessments (for example related to health or the environment) but must also take into account consumer perceptions and preferences. In addition, consumers make decisions about food choices
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Safety Information System Guide
International Nuclear Information System (INIS)
Bullock, M.G.
1977-03-01
This Guide provides guidelines for the design and evaluation of a working safety information system. For the relatively few safety professionals who have already adopted computer-based programs, this Guide may aid them in the evaluation of their present system. To those who intend to develop an information system, it will, hopefully, inspire new thinking and encourage steps towards systems safety management. For the line manager who is working where the action is, this Guide may provide insight on the importance of accident facts as a tool for moving ideas up the communication ladder where they will be heard and acted upon; where what he has to say will influence beneficial changes among those who plan and control his operations. In the design of a safety information system, it is suggested that the safety manager make friends with a computer expert or someone on the management team who has some feeling for, and understanding of, the art of information storage and retrieval as a new and better means for communication
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Predicting Drug Safety and Communicating Risk: Benefits of a Bayesian Approach.
Lazic, Stanley E; Edmunds, Nicholas; Pollard, Christopher E
2018-03-01
Drug toxicity is a major source of attrition in drug discovery and development. Pharmaceutical companies routinely use preclinical data to predict clinical outcomes and continue to invest in new assays to improve predictions. However, there are many open questions about how to make the best use of available data, combine diverse data, quantify risk, and communicate risk and uncertainty to enable good decisions. The costs of suboptimal decisions are clear: resources are wasted and patients may be put at risk. We argue that Bayesian methods provide answers to all of these problems and use hERG-mediated QT prolongation as a case study. Benefits of Bayesian machine learning models include intuitive probabilistic statements of risk that incorporate all sources of uncertainty, the option to include diverse data and external information, and visualizations that have a clear link between the output from a statistical model and what this means for risk. Furthermore, Bayesian methods are easy to use with modern software, making their adoption for safety screening straightforward. We include R and Python code to encourage the adoption of these methods.
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Yang, Jianzhou; Xie, Rihua; Krewski, Daniel; Wang, Yongjin; Walker, Mark; Cao, Wenjun; Wen, Shi Wu
2014-01-01
Changing health care providers frequently breaks the continuity of care, which is associated with many health care problems. The purpose of this study was to examine the association between a change of health care providers and pregnancy exposure to FDA category C, D and X drugs. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 were chosen for this study. The association between the number of changes in health care providers and with pregnancy exposure to category C, D, and X drugs for those women with and without chronic diseases were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 568 women were included in this study. Rates of FDA C, D, and X drug uses were 14.35%, 17.07%, 21.72%, and 31.14%, in women with no change of provider, 1-2 changes, 3-5 changes, and more than 5 changes of health care providers. An association between the number of changes of health care providers and pregnancy exposure to FDA C, D, and X drugs existed in women without chronic diseases but not in women with chronic disease. Change of health care providers is associated with pregnancy exposure to FDA category C, D and X drugs in women without chronic diseases.
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2010-10-01
... 47 Telecommunication 5 2010-10-01 2010-10-01 false RF safety. 95.1125 Section 95.1125 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1125 RF safety. Portable devices...
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Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D
2007-01-01
Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.
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General Accounting Office, Washington, DC.
This report presents information on the status of the safety and use of polio vaccines in the United States. Topics discussed include: (1) the role of the Food and Drug Administration (FDA) in processing an inactivated polio vaccine license application; (2) the steps the federal government has taken to improve the safety of the vaccine; (3) the…
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Validation of IT-based Data Communication Protocol for Nuclear Power Plant
International Nuclear Information System (INIS)
Jeong, K. I.; Kim, D. H.; Lee, J. C.
2009-12-01
The communication network designed to transmit control and processing signals in digital Instrument and Control (I and C) systems in Nuclear Power Plant (NPP), should provide a high level of safety and reliability. There are different features between the communication networks of NPPs and other commercial communication networks. Safety and reliability are the most important factors in the communication networks of an NPP rather than efficiency which are important factors of a commercial communication network design. To develop Data Communication Protocol for Nuclear Power Plant, We analyze the design criteria and performance requirements of existing commercial communication protocols based on Information Technology(IT). And also, we examine the adaptability to the communication protocol of an NPP. Based on these results, we developed our own protocol(Nuclear power plant Safety Communication Protocol : NSCP) for NPP I and C, which meet the required specifications through design overall protocol architecture and data frame format, definition of functional requirements and specifications. NSCP is the communication protocol designed for a safety-grade control network in the nuclear power plant. In this report, we had specified NSCP protocol by FDT(Formal Description Technique) and established validation procedures based on the validation methodology. It was confirmed specification error, major function's validity and reachability of NSCP by performing simulation and the validation process using Telelogic Tau tool
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Nuclear post-accident communication: reflections of CODIR-PA's 'Communication' work group (GT8)
International Nuclear Information System (INIS)
2010-01-01
This document briefly presents the approach adopted in France to define a communication doctrine to be applied in a post-accident situation, to make practical recommendations to actors, and to develop practical tools (speech elements). It evokes the main themes dealt with (such as safety culture, communication, etc.) by a specific work group
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2010-10-01
... 47 Telecommunication 5 2010-10-01 2010-10-01 false RF safety. 90.1335 Section 90.1335 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Wireless Broadband Services in the 3650-3700 MHz Band § 90.1335 RF safety...
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Merenstein, Daniel J; Tan, Tina P; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert F; Shara, Nawar M; Mete, Mihriye; Sanders, Mary Ellen; Solano-Aguilar, Gloria
2015-01-01
Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states.
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Directory of Open Access Journals (Sweden)
Gausvik C
2015-01-01
Full Text Available Christian Gausvik,1 Ashley Lautar,2 Lisa Miller,2 Harini Pallerla,3 Jeffrey Schlaudecker4,5 1University of Cincinnati College of Medicine, 2The Christ Hospital, Cincinnati, OH, USA; 3Department of Family and Community Medicine, 4Division of Geriatric Medicine, University of Cincinnati, Cincinnati, OH, USA; 5Geriatric Medicine Fellowship Program, University of Cincinnati/The Christ Hospital, Cincinnati, OH, USA Abstract: Efficient, accurate, and timely communication is required for quality health care and is strongly linked to health care staff job satisfaction. Developing ways to improve communication is key to increasing quality of care, and interdisciplinary care teams allow for improved communication among health care professionals. This study examines the patient- and family-centered use of structured interdisciplinary bedside rounds (SIBR on an acute care for the elderly (ACE unit in a 555-bed metropolitan community hospital. This mixed methods study surveyed 24 nurses, therapists, patient care assistants, and social workers to measure perceptions of teamwork, communication, understanding of the plan for the day, safety, efficiency, and job satisfaction. A similar survey was administered to a control group of 38 of the same staff categories on different units in the same hospital. The control group units utilized traditional physician-centric rounding. Significant differences were found in each category between the SIBR staff on the ACE unit and the control staff. Nurse job satisfaction is an important marker of retention and recruitment, and improved communication may be an important aspect of increasing this satisfaction. Furthermore, improved communication is key to maintaining a safe hospital environment with quality patient care. Interdisciplinary team rounds that take place at the bedside improve both nursing satisfaction and related communication markers of quality and safety, and may help to achieve higher nurse retention and safer
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Crisis Communications in a Digital World
Trump, Kenneth S.
2015-01-01
Kenneth Trump, a school safety expert who consults with districts on how to respond to school safety crises, explains how the new prevalence of threats of violence being delivered over digital and social media creates for administrators a "communication crisis" that unfolds alongside the real or perceived crisis of school safety being…
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Management of safety and safety culture at the NPPs of Ukraine
International Nuclear Information System (INIS)
Koltakov, Vladimir
2002-01-01
The report contains general aspects of safety and safety culture. The brief description of operational characteristics and basic indexes of atomic power plants at the Ukraine are represented. The information referring to structure of NPPs of Operation organization license-holder, safety responsibility of both Regulatory and Utility Bodies also is given. The main part of the report include seven sections: 1. Practical application of safety management models; 2. erspective on the relationship between safety management and safety culture; 3. The role of leadership in achieving high standards of safety; 4. Current and future challengers that impact on safety culture and safety management (e.g. the impact of competition, changing, economic and political circumstances, workforce demographics, etc.); 5. Key lessons learned from major events; 6. Practical applications of safety culture concepts (e.g. learning organizations, training staff communications, etc.); 7. dvance in human performance. Some of the main pending safety and safety culture problems that are necessary to achieve in the near future are mentioned
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International laser-safety regulations: a status update
Weiner, Robert M.
1990-07-01
There is an increase in international laser safety requirements as part of the emphasis on world-wide standardization of products and regulations. In particular the documents which will evolve from the 1992 consolidation efforts of the European Community (EC) will impact both laser manufacturers and users. This paper provides a discussion of the current status of the various laser radiation standards. NORTH AMERICAN REQUIREMENTS United States Requirements on manufacturers from the Food and Drug Administration (FDA) have been in effect since 1975. The Center for Devices and Radiological Health (CDRH) within that agency ensures that these mandatory requirements [1] are satisfied. The CDRH regulations include the division of products into classes depending on their potential for hazard criteria for power measurement and requirements for product features labels and manuals and records and reports. Manufacturers must test products and certify that they comply with the CDRH requirements. User requirements are found in a standard published by the American National Standards Institute (ANSI) and in requirements from several individual states. Specific ANSI standards have also been published for fiber communications systems [34] and for lasers in medical applications [35]. Please note that the Appendix includes additional information on the standards discussed in this paper including sources for obtaining the documents. Canada In the past Canada has had requirements for two specified product categories (bar code scanners and educational lasers) [26 These will be replaced
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2012-08-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001... include an update on the FDA Safety and Innovation Act (Pub. L. 112-144) and an overview of FDA's Network... liaison between FDA Centers and the public on matters that involve medical product safety and also acts as...
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Directory of Open Access Journals (Sweden)
Ernest S. Fung
2018-06-01
Full Text Available Organizations recommend evaluating individual ingredients when assessing the safety of personal care or cosmetic products. The goal of this study was to present a screening-level safety assessment methodology to evaluate the safety of a product by identifying individual ingredients, determining their frequency of use in on-market products, and examining published safe-level-of-use information for each ingredient. As a case study, we evaluated WEN by Chaz Dean (WCD cleansing conditioners since there have been claims of adverse health effects associated with product use. We evaluated 30 ingredients in three on-market WCD cleansing conditioners. We then analyzed the National Library of Medicine’s Household Products Database and the Environmental Working Group’s (EWG Skin Deep Cosmetic Database, two of the largest publicly available databases, for other on-market personal care and cosmetic products that contained these ingredients. Safe-level-of-use information for each ingredient was obtained by reviewing peer-reviewed literature, the Food and Drug Administration’s (FDA generally recognized as safe (GRAS database, available Cosmetic Ingredient Review (CIR publications, and available product safety publications. The results of this analysis showed that more than 20,000 personal care and cosmetic products contained one or more of the evaluated ingredients used in WCD cleaning conditioners. Published safety information was available for 21 of the 30 evaluated ingredients: seven identified ingredients were designated as GRAS by the FDA and 16 ingredients had safe-level-of-use information available from the CIR. This study presents a screening-level safety assessment methodology that can serve as an initial screening tool to evaluate the safety of an ingredient intended for use in personal care and cosmetic products before a product is launched onto the market. This study provides evidence that the evaluated WCD cleansing conditioner ingredients
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Carey, Kate B.; Lust, Sarah A.; Reid, Allecia E.; Kalichman, Seth C.; Carey, Michael P.
2015-01-01
Relatively little research has examined how peer communication influences alcohol consumption. In a sample of mandated college students, we differentiate conversations about drinking among from conversations about harm prevention and provide evidence for the validity of these communication constructs. Students who violated campus alcohol policies and were referred for alcohol sanctions (N = 345) reported on drinking patterns, use of protective behavioral strategies, perceived descriptive norms for close friends and serving as social leader among their friends; they also reported on the frequency of conversations about drinking, about drinking safety, and about risk reduction efforts. Predicted correlations were found among types of communication and conceptually related variables. General communication was related to consumption but not protective behavioral strategies, whereas safety/risk reduction conversations correlated positively with all protective behavioral strategies. Both types of communication were associated with social leadership. Safety communication moderated the relationship between peer descriptive norms and drinks per week; more frequent talking about safety attenuated the norms-consumption relationship. Peer communication about both drinking and safety may serve as targets for change in risk reduction interventions for mandated college students. PMID:26861808
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Communicating with the public about risk
International Nuclear Information System (INIS)
Wade, C.R.; Molony, S.T.; Durbin, M.E.; Klein, S.H.; Wahl, L.E.
1992-01-01
Risk communication is a growing specialty field in communication that draws from well-established principles of sociology and psychology. It is a new way to communicate with potentially hostile audiences about sensitive environmental, safety, and health issues they face. This paper explains the most important principles of risk communication and discusses audience analyses, perceptions of risk (outrage factors), and risk comparisons. These principles are applied to a risk communication issue in Malhuevo, a fictitious Arizona community
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The role of communication in paediatric drug safety
Stebbing, Claire; Wong, Ian C K; Kaushal, Rainu; Jaffe, Adam
2007-01-01
Medication errors cause substantial harm to patients, and considerable cost to healthcare systems. Evidence suggests that communication plays a crucial role in the generation, management and prevention of such incidents. This review identifies how paediatric medication errors can be managed, and in particular focuses on the pathway of steps that can operationalise the current research findings. Furthermore, the current data suggesting how communication can help to prevent errors occurring in ...
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2010-10-01
... 47 Telecommunication 5 2010-10-01 2010-10-01 false RF safety. 101.1425 Section 101.1425 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE... safety. MVDDS stations in the 12.2-12.7 GHz frequency band do not operate with output powers that equal...
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14 CFR 415.33 - Safety organization.
2010-01-01
... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Safety organization. 415.33 Section 415.33....33 Safety organization. (a) An applicant shall maintain a safety organization and document it by... communication, both within the applicant's organization and between the applicant and any federal launch range...
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Informing Workers of Chemical Hazards: The OSHA Hazard Communication Standard.
American Chemical Society, Washington, DC.
Practical information on how to implement a chemical-related safety program is outlined in this publication. Highlights of the federal Occupational Safety and Health Administrations (OSHA) Hazard Communication Standard are presented and explained. These include: (1) hazard communication requirements (consisting of warning labels, material safety…
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International Nuclear Information System (INIS)
Kavsek, D.
2004-01-01
The strengthening of safety culture in an organization has become an increasingly important issue for nuclear industry. A high level of safety performance is essential for business success in intensely competitive global environment. This presentation offers a discussion of some principles and activities used in enhancing safety performance and appropriate safety behaviour at the Krsko NPP. Over the years a number of events have occurred in nuclear industry that have involved problems in human performance. A review of these and other significant events has identified recurring weaknesses in plant safety culture and policy. Focusing attention on the strengthening of relevant processes can help plants avoid similar undesirable events. The policy of the Krsko NPP is that all employees concerned shall constantly be alert to opportunities to reduce risks to the lowest practicable level and to achieve excellence in plant safety. The most important objective is to protect individuals, society and the environment by establishing and maintaining an effective defense against radiological hazard in the nuclear power plant. It is achieved through the use of reliable structures, components, systems, and procedures, as well as plant personnel committed to a strong safety culture. The elements of safety culture include both organizational and individual aspects. Elements commonly included at the organizational level are senior management commitment to safety, organizational effectiveness, effective communication, organizational learning, and a culture that encourages identification and resolution of safety issues. Elements identified at the individual level include personal accountability, a questioning attitude, communication, procedural adherence, etc.(author)
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Pursuing for the case of safety
Energy Technology Data Exchange (ETDEWEB)
Hansen, H; Salaber, A [Geco-Prakla, Paris (France); Myers, S [Sedco Forex, Montrouge (France); Redd, E [Sedco Forex, Aberdeen (United Kingdom); Shannon, R [Anadrill HSE, London (United Kingdom)
1993-01-01
Ever since the Piper Alpha disaster, safety has become one of the industry's hottest issues. Attention to safety leads to improved communication within organizations as well as between operators and contractors, and ultimately to more efficient operations. In this article descriptions are given of safety management systems, the safety-case philosophy and legislative changes hat are helping promote these new safety tools. 6 figs., 4 ills., 3 refs.
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Pursuing for the case of safety
Energy Technology Data Exchange (ETDEWEB)
Hansen, H.; Salaber, A. (Geco-Prakla, Paris (France)); Myers, S. (Sedco Forex, Montrouge (France)); Redd, E. (Sedco Forex, Aberdeen (United Kingdom)); Shannon, R. (Anadrill HSE, London (United Kingdom))
1993-01-01
Ever since the Piper Alpha disaster, safety has become one of the industry's hottest issues. Attention to safety leads to improved communication within organizations as well as between operators and contractors, and ultimately to more efficient operations. In this article descriptions are given of safety management systems, the safety-case philosophy and legislative changes hat are helping promote these new safety tools. 6 figs., 4 ills., 3 refs.
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30 CFR 56.18013 - Emergency communications system.
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Emergency communications system. 56.18013 Section 56.18013 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND... Programs § 56.18013 Emergency communications system. A suitable communication system shall be provided at...
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DEFF Research Database (Denmark)
Andersson, K.; Sjöberg, B.M.D.; Lauridsen, Kurt
2003-01-01
The aim of the NKS/SOS-1 project has been to enhance common understanding about requirements for nuclear safety by finding improved means of communicat-ing on the subject in society. The project, which has been built around a number of seminars, wassupported by limited research in three sub......-projects: Risk assessment Safety analysis Strategies for safety management The report describes an industry in change due to societal factors. The concepts of risk and safety, safety management and systems forregulatory oversight are de-scribed in the nuclear area and also, to widen the perspective, for other...
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Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo
2018-02-01
This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.
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Enhancing Transparency in Multidisciplinary Expert Communication
International Nuclear Information System (INIS)
Hukki, Kristiina; Pulkkinen, Urho
2003-01-01
Faced with problems of public acceptance most nuclear waste management organisations now acknowledge the importance of transparency in their pursuit of solutions for high-level nuclear waste disposal. To make progress the implementing organizations need the trust of other stakeholders in the decision-making process. For such trust these outside stakeholders need knowledge on the grounds for the judgments and decisions made in different scientific and technical disciplines. Transparency is, however, at least as important for the multidisciplinary expert communication itself. As a matter of fact, the transparency of the internal expert interaction processes is a prerequisite for the true transparency of the communication between the implementer and the external stakeholder groups. The introduced conceptual framework has been developed for the identification of the requirements of safety-informed communication in multidisciplinary expert work in nuclear waste management. The framework offers a common thinking model and common concepts which can be utilized in the development of the communication practices. The basis of the framework is on the possibility to understand the safety-critical significance of one's work. The transparency of communication is, for its part, based on making explicit the relevant knowledge necessary for gaining the understanding. This supplementary knowledge, which is related to the substance issues but is not scientific-technical by nature, enhances the experts' awareness of the context of their own contribution and of the background of the other experts' contributions. The common conceptualization and modelling of the knowledge-related dependencies between the tasks make it possible to realize the significance of the supplementary knowledge for transparent communication in actual situations. They also facilitate the recognition of the need for different types of supplementary knowledge in the interfaces between the tasks. By enhancing mutual
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The Internet and drug safety: what are the implications for pharmacovigilance?
Cobert, B; Silvey, J
1999-02-01
Use of the Internet is becoming widespread throughout the world. Its use in the domain of drug safety and pharmacovigilance is spreading rapidly. Governments and industry have taken the lead in developing extensive web sites. The US Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other agencies have developed sites containing enormous amounts of information both on pharmacovigilance in general and on specific drugs in particular. Under the US 'Freedom of Information Act' the FDA has put major parts of its adverse event database on line. Regulatory documents are also available from the FDA site or from hyperlinks described in the site. The US Center for Drug Evaluation and Research updates its site most days and maintains a free automated e-mail announcement service of these updates. Similarly, the EMEA updates its site frequently and publishes extensive material including regulatory documents, guidelines, European Public Assessment Reports on newly approved medications and other useful information. A free update service by e-mail is also available. Although English is the primary language used on the EMEA site, some of the information is available in other languages. Pharmaceutical companies are not using the Internet for pharmacovigilance yet. Rather, the Internet is being used for promotion of their products and for informing consumers on general information on diseases, for financial and investor data and for employment opportunities, etc. Other organisations such as lobbies, consumer groups and medical journals are also beginning to use the Internet. The electronic transmission of safety information, using the standards developed by the International Conference on Harmonization, is currently being tested for the transmission of individual patient adverse event information between companies and governments. In addition, the FDA has begun to accept adverse events from healthcare providers and consumers
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2010-10-01
... 47 Telecommunication 5 2010-10-01 2010-10-01 false RF safety. 101.1525 Section 101.1525 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Service and Technical Rules for the 70/80/90 GHz Bands § 101.1525 RF safety. Licensees in the 70...
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14 CFR 431.33 - Safety organization.
2010-01-01
... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Safety organization. 431.33 Section 431.33... Launch and Reentry of a Reusable Launch Vehicle § 431.33 Safety organization. (a) An applicant shall maintain a safety organization and document it by identifying lines of communication and approval authority...
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Magnetic resonance imaging: hazard, risk and safety
International Nuclear Information System (INIS)
Narayan, Pradeep; Suri, S.; Singh, P.
2001-01-01
The hazard and risk associated with magnetic resonance imaging is a matter of concern. In 1982, the Food and Drug Administration (FDA), USA issued guidelines to Hospital's Investigational Review Board (IRBs) in 'Guidelines for Evaluating Electromagnetic Exposure Risks for Trials of Clinical Nuclear Magnetic Resonance (NMR)'. In 1997, the Berufsgenossenschaft (BG), professional association for precision engineering and electronics of Germany, in their preliminary proposal for safety limits extended their concerns on static magnetic field. Owing to both time varying and static magnetic fields applied in Magnetic Resonance Imaging (MRI) this became of immediate concern to user community to assess the potential hazard and risk associated with the NMR system
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Safety evaluation for communication network software modifications of PCS in Ulchin NPP unit 3
International Nuclear Information System (INIS)
Ji, S. H.; Koh, J. S.; Kim, B. R.; Oh, S. H.
1999-01-01
On February 2, 1999, an incident occurred at the Ulchin Nuclear Power Plant Unit 3 which resulted in the corruption of data on Perform Net of Plant Control System. This incident was caused by the ASIC (Application Specific Integrated Circuit) chip on the Rehostable Module which is a part of Network Interface Module. Regarding this incident, we required that the utility should propose new algorithms to detect the hardware failure of ASIC chip and evaluated the appropriateness of network software modifications. As a result of this evaluation process, we required that the safety related interlock signals using data communication path be hardwired to make up for the vulnerability of the system architecture. In this paper, we will discuss the system architecture of PCS and fault analysis and evaluation findings
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Directory of Open Access Journals (Sweden)
Marcella H. Boynton
2016-06-01
Full Text Available Abstract Background The passage of the 2009 Family Smoking Prevention and Tobacco Control Act has necessitated the execution of timely, innovative, and policy-relevant tobacco control research to inform Food and Drug Administration (FDA regulatory and messaging efforts. With recent dramatic changes to tobacco product availability and patterns of use, nationally representative data on tobacco-related perceptions and behaviors are vital, especially for vulnerable populations. Methods The UNC Center for Regulatory Research on Tobacco Communication conducted a telephone survey with a national sample of adults ages 18 and older living in the United States (U.S.. The survey assessed regulatory relevant factors such as tobacco product use, tobacco constituent perceptions, and tobacco regulatory agency credibility. The study oversampled high smoking/low income areas as well as cell phone numbers to ensure adequate representation among smokers and young adults, respectively. Coverage extended to approximately 98 % of U.S. households. Results The final dataset (N = 5,014 generated weighted estimates that were largely comparable to other national demographic and tobacco use estimates. Results revealed that over one quarter of U.S. adults, and over one third of smokers, reported having looked for information about tobacco constituents in cigarette smoke; however, the vast majority was unaware of what constituents might actually be present. Although only a minority of people reported trust in the federal government, two thirds felt that the FDA can effectively regulate tobacco products. Conclusions As the FDA continues their regulatory and messaging activities, they should expand both the breadth and availability of constituent-related information, targeting these efforts to reach all segments of the U.S. population, especially those disproportionately vulnerable to tobacco product use and its associated negative health outcomes.
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Improving Pathologists' Communication Skills.
Dintzis, Suzanne
2016-08-01
The 2015 Institute of Medicine report on diagnostic error has placed a national spotlight on the importance of improving communication among clinicians and between clinicians and patients [1]. The report emphasizes the critical role that communication plays in patient safety and outlines ways that pathologists can support this process. Despite recognition of communication as an essential element in patient care, pathologists currently undergo limited (if any) formal training in communication skills. To address this gap, we at the University of Washington Medical Center developed communication training with the goal of establishing best practice procedures for effective pathology communication. The course includes lectures, role playing, and simulated clinician-pathologist interactions for training and evaluation of pathology communication performance. Providing communication training can help create reliable communication pathways that anticipate and address potential barriers and errors before they happen. © 2016 American Medical Association. All Rights Reserved.
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Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza
2007-01-01
The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources.
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2013-01-16
... Rational Questionnaire) and the Electronic Submission Gateway (ESG) are the Agency's electronic systems for collecting, submitting, and processing adverse event reports and other safety information for FDA-regulated... FDA Safety Reporting Portal Rational Questionnaires FDA currently has OMB approval to receive three...
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21 CFR 1.378 - What criteria does FDA use to order a detention?
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What criteria does FDA use to order a detention? 1.378 Section 1.378 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...
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A study on methodologies for assessing safety critical network's risk impact on Nuclear Power Plant
International Nuclear Information System (INIS)
Lim, T. J.; Lee, H. J.; Park, S. K.; Seo, S. J.
2006-08-01
The objectives of this project is to investigate and study existing reliability analysis techniques for communication networks in order to develop reliability analysis models for Nuclear Power Plant's safety-critical networks. It is necessary to make a comprehensive survey of current methodologies for communication network reliability. Major outputs of the first year study are design characteristics of safety-critical communication networks, efficient algorithms for quantifying reliability of communication networks, and preliminary models for assessing reliability of safety-critical communication networks
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Interpersonal communication and issues for autonomous vehicles.
2017-06-01
Interpersonal roadway communication is a vital component of the transportation system. Road users communicate to coordinate movement and increase roadway safety. Future autonomous vehicle research needs to account for the role of interpersonal roadwa...
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International Nuclear Information System (INIS)
Krug, Steven E.
2008-01-01
The practice of pediatric emergency medicine (PEM) has been supported by wonderful advancements in diagnostic testing, particularly in medical imaging. One of the most remarkable has been CT, which has arguably become our most valuable diagnostic tool in the emergency department (ED). PEM specialists have grown increasingly aware of quality and safety concerns in the care of children in emergency medical settings, spurred in part by a rapid growth in ED utilization and significant overcrowding. In the midst of this comes the revelation that one of our most valued diagnostic tools might place our youngest patients at a significant risk for the development of fatal cancer. This article reinforces the fundamental importance of communication and teamwork as a means to promote patient care quality and safety in the ED, and it offers partnership strategies for PEM and pediatric radiology specialists to consider as they address these important concerns. (orig.)
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Energy Technology Data Exchange (ETDEWEB)
Krug, Steven E. [Northwestern University, Children' s Memorial Hospital, Feinberg School of Medicine, Chicago, IL (United States)
2008-11-15
The practice of pediatric emergency medicine (PEM) has been supported by wonderful advancements in diagnostic testing, particularly in medical imaging. One of the most remarkable has been CT, which has arguably become our most valuable diagnostic tool in the emergency department (ED). PEM specialists have grown increasingly aware of quality and safety concerns in the care of children in emergency medical settings, spurred in part by a rapid growth in ED utilization and significant overcrowding. In the midst of this comes the revelation that one of our most valued diagnostic tools might place our youngest patients at a significant risk for the development of fatal cancer. This article reinforces the fundamental importance of communication and teamwork as a means to promote patient care quality and safety in the ED, and it offers partnership strategies for PEM and pediatric radiology specialists to consider as they address these important concerns. (orig.)
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Communication planning by the nuclear regulatory body
International Nuclear Information System (INIS)
2002-01-01
The national regulatory body, whose primary mission is to exercise regulatory control over nuclear facilities and the use of radiation sources, but not to promote their use, may be the most credible source of neutral, balanced and accurate information about issues relating to nuclear and radiation safety. It is therefore important for a regulatory body to establish and exercise an effective communication programme to acquaint the public with its oversight functions, capabilities and effectiveness. If the regulatory body is to maintain credibility and to deal promptly and effectively with nuclear or radiological accidents and any other events that may give rise to significant public concerns, and is to communicate clearly and effectively with the public, it must have adequate resources, including experts in nuclear safety. And if maintaining public confidence in the authorities and avoiding unnecessary concerns are among its principal objectives, it must be able to communicate understandably and truthfully about the known extent of any accident, the actions taken in response to it and its implications. In the past, psychological effects as a result of certain severe nuclear and radiological accidents have been compounded by a lack of candour with the public on the part of the authorities and an absence of an appropriate programme of public information. This publication describes good practices and gives practical examples of how the regulatory body can establish a systematic and structured programme for enhancing effective communication with various parties and under various circumstances. The report presupposes an adequate national infrastructure, including an independent regulatory body with sufficient authority and resources to discharge its responsibilities for the regulation of safety. This Safety Report covers the elements of a regulatory body's programme for communication with various audiences and under the different circumstances that may be encountered
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Administrative Management Competencies for Safety Professionals.
Blair, Earl H.; Logan, Joyce P.
1999-01-01
In a 1997 study, 245 safety professionals and educators identified and prioritized management competencies that are important for safety professionals. Results show that the most important competencies are communication, listening, motivating others, creative thinking, and flexibility. (JOW)
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Study on communicating risk information obtained from PSA within nuclear power plants
International Nuclear Information System (INIS)
Nunogane, Nobuaki; Onoue, Akira; Kojima, Shigeo
2000-01-01
In this study, the communication of PSA information in nuclear power plants (NPPs), namely, how the risk information obtained from the probabilistic safety assessment (PSA) should be presented and communicated to plant personnel, was examined assuming that the safety management system based on the risk information was introduced to NPPs. This is called PSA communication. First, when risk-informed safety management is to be introduced into NPPs, plant personnel should have sufficient related knowledge. In order to provide such knowledge to the personnel through training, risk information is classified into three types: basic information, detailed information and task information. A hierarchical risk information summary for reporting, coordinating and communicating tasks is proposed. In this summary, the concerns of those who have received the information are placed at the top and the related risk information positioned below. At the same time, and by way of a trial, the risk information relating to on-line maintenance (OLM) is prepared. In order to enhance the safety-consciousness and the safety of the entire plant, specific plans such as 'risk tags' which indicate the safety significance of equipment is proposed. Finally, a guideline providing examination procedures for developing detailed PSA communication plans is introduced. (author)
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Abdulhamid, Mahmoud A.; Ma, Xiaohua; Miao, Xiaohe; Pinnau, Ingo
2017-01-01
,11-methanodibenzo[a,e][8]annulene (iCTBDA), were designed for the synthesis of microporous 6FDA-based polyimides (6FDA-CTBDA and 6FDA-iCTBDA). Both polyimides were soluble, exhibited excellent thermal stability of ∼490 °C, and had high surface areas of 587 m2 g−1 (6
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NKS/SOS-1 seminar on safety analysis
Energy Technology Data Exchange (ETDEWEB)
Lauridsen, K. [Risoe National Lab., Roskilde (Denmark); Anderson, K. [Karinta-Konsult (Sweden); Pulkkinen, U. [VTT Automation (Finland)
2001-05-01
The report describes presentations and discussions at a seminar held at Risoe on March 22-23, 2000. The title of the seminar was NKS/SOS-1 - Safety Analysis. It dealt with issues of relevance for the safety analysis for the entire nuclear safety field (notably reactors and nuclear waste repositories). Such issues were: objectives of safety analysis, risk criteria, decision analysis, expert judgement and risk communication. In addition, one talk dealt with criteria for chemical industries in Europe. The seminar clearly showed that the concept of risk is multidimensional, which makes clarity and transparency essential elements in risk communication, and that there are issues of common concern between different applications, such as how to deal with different kinds of uncertainty and expert judgement. (au)
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Safety-barrier diagrams as a tool for modelling safety of hydrogen applications
DEFF Research Database (Denmark)
Duijm, Nijs Jan; Markert, Frank
2009-01-01
Safety-barrier diagrams have proven to be a useful tool in documenting the safety measures taken to prevent incidents and accidents in process industry. Especially during the introduction of new hydrogen technologies or applications, as e.g. hydrogen refuelling stations, safety-barrier diagrams...... are considered a valuable supplement to other traditional risk analysis tools to support the communication with authorities and other stakeholders during the permitting process. Another advantage of safety-barrier diagrams is that they highlight the importance of functional and reliable safety barriers in any...... system and here is a direct focus on those barriers that need to be subject to safety management in terms of design and installation, operational use, inspection and monitoring, and maintenance. Safety-barrier diagrams support both quantitative and qualitative approaches. The paper will describe...
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STATE-MANDATED FOOD SAFETY CERTIFICATION REQUIREMENTS FOR RESTAURANTS: A 2002 REVIEW OF STATES
Schilling, Brian J.; O'Connor, Jack; Hendrickson, Veronica
2003-01-01
The Food and Drug Administration publishes a Standard Food Code which individual states either ratify, or amend and ratify, as the State Food Code. New Jersey has not adopted any revisions to the FDA Standard Food Code since 1993. Currently, the New Jersey Department of Health and Senior Services is considering the implementation of a mandatory food safety certification program for all of the state's foodservice establishments beginning in April 2003. Foodservice businesses serving "high risk...
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A Communication Training Program to Encourage Speaking-Up Behavior in Surgical Oncology.
D'Agostino, Thomas A; Bialer, Philip A; Walters, Chasity B; Killen, Aileen R; Sigurdsson, Hrafn O; Parker, Patricia A
2017-10-01
Patient safety in the OR depends on effective communication. We developed and tested a communication training program for surgical oncology staff members to increase communication about patient safety concerns. In phase one, 34 staff members participated in focus groups to identify and rank factors that affect speaking-up behavior. We compiled ranked items into thematic categories that included role relations and hierarchy, staff rapport, perceived competence, perceived efficacy of speaking up, staff personality, fear of retaliation, institutional regulations, and time pressure. We then developed a communication training program that 42 participants completed during phase two. Participants offered favorable ratings of the usefulness and perceived effect of the training. Participants reported significant improvement in communicating patient safety concerns (t 40 = -2.76, P = .009, d = 0.48). Findings offer insight into communication challenges experienced by surgical oncology staff members and suggest that our training demonstrates the potential to improve team communication. Copyright © 2017 AORN, Inc. Published by Elsevier Inc. All rights reserved.
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Directory of Open Access Journals (Sweden)
Raghavendra Charan P Makam
Full Text Available Direct oral anticoagulants (DOACs have emerged as promising alternatives to vitamin K antagonists (VKAs for patients with non-valvular atrial fibrillation (NVAF or venous thromboembolism (VTE. Few meta-analyses have included all DOACs that have received FDA approval for these cardiovascular indications, and their overall comparisons against VKAs have shortcomings in data and methods. We provide an updated overall assessment of the efficacy and safety of those DOACs at dosages currently approved for NVAF or VTE, in comparison with VKAs.We used data from Phase 3 randomized trials that compared an FDA-approved DOAC with VKA for primary prevention of stroke in patients with NVAF or for treatment of acute VTE.Among trial participants with NVAF, DOAC recipients had a lower risk of stroke or systemic embolism [Pooled Odds Ratio (OR 0.76, 95% Confidence Interval (CI (0.68-0.84], any stroke (0.80, 0.73-0.88, systemic embolism (0.56, 0.34-0.93, and total mortality (0.89, 0.84-0.95. Safety outcomes also showed a lower risk of fatal, major, and intracranial bleeding but higher risk for gastrointestinal bleeding (GIB. Patients with acute VTE randomized to DOACs had comparable risk of recurrent VTE and death (OR 0.88, 95% CI 0.75-1.03, recurrent DVT (0.83, 0.66-1.05, recurrent non-fatal PE (0.97, 0.75-1.25, and total mortality (0.94, 0.79-1.12. Safety outcomes for DOACs showed a lower risk of major, fatal, and intracranial bleeding, but similar risk of GIB.Patients receiving DOACs for NVAF had predominantly superior efficacy and safety. Patients who were treated with DOACs for acute VTE had non-inferior efficacy, but an overall superior safety profile.
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Allan, M C
1992-01-01
To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are presented in an appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction ;of the components