WorldWideScience

Sample records for regulatory post marketing

  1. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    Science.gov (United States)

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  2. Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges.

    Science.gov (United States)

    Blandizzi, Corrado; Galeazzi, Mauro; Valesini, Guido

    2018-02-01

    Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians. Based on these arguments, the present article was intended to review information on the main differences between first- and second-generation biosimilars for treatment of immune-mediated inflammatory diseases, as well as their impact on immunogenicity, the design of clinical trials and the critical issue of extrapolation of therapeutic indications. The positions taken by relevant medical associations and the crucial role of pharmacovigilance are also reviewed. According to current knowledge, the initial post-marketing clinical experience with second-generation biosimilars is providing encouraging results, though their long-term safety and efficacy as well as the scientific basis underlying the extrapolation of therapeutic indications are still matter of discussion. There is some consensus that marketing applications should rely on studies supporting the clinical use of biosimilars in their different target diseases and patient populations. In parallel, clinical safety must be ensured by a strict control of the manufacturing processes and a solid pharmacovigilance program. It remains then a responsibility of the physician to drive a proper use of second-generation biosimilars into clinical practice, in accordance with guidelines issued by scientific societies. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective.

    Science.gov (United States)

    Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

    2017-06-01

    The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.

  4. Regulatory actions post - Fukushima

    International Nuclear Information System (INIS)

    Ciurea Ercau, C.

    2013-01-01

    The paper presents the results of the safety reviews performed in Romania after the Fukushima accident and the resulting actions for improving the safety. The actions taken by the National Commission for Nuclear Activities Control (CNCAN) to improve the regulatory framework include the development of new regulations and the enhancement of inspection practices, taking account of the lessons learned from the Fukushima accident. A regulation on the response to transients, accidents and emergency situations at nuclear power plants has been developed, which includes requirements on transient and accident scenarios that have to be covered by the Emergency Operating Procedures (EOPs), accident scenarios to be covered by the Severe Accident Management Guidelines (SAMGs), emergency situations to be covered by the on-site emergency response plan and emergency response procedures. (authors)

  5. Interchangeability of biosimilar and biological reference product: updated regulatory positions and pre- and post-marketing evidence.

    Science.gov (United States)

    Trifirò, Gianluca; Marcianò, Ilaria; Ingrasciotta, Ylenia

    2018-03-01

    Since 2006, biosimilars have been available in several countries worldwide, thus allowing for potential savings in pharmaceutical expenditure. However, there have been numerous debates about the interchangeability of biosimilars and reference products based on concerns of immunogenicity by switching between biological products, which may cause lack of effect and toxicity. Areas covered: The authors provide the reader with an overview of the different positions of regulatory authorities on the interchangeability and automatic substitution of biosimilars and reference products. Presently, the FDA allows automatic substitution without prescriber intervention if the biosimilar is interchangeable with reference products, while the European Medicines Agency delegate to each single EU member state. Expert opinion: Different approaches in defining interchangeability and automatic substitution call for harmonization to increase confidence of healthcare professionals and patients about the clinical impact of switching. Networks of electronic healthcare records and administrative databases, potentially linkable to clinical charts and registries may rapidly assess frequency and benefit-risk profile of different switching patterns in routine care at different levels, thus integrating and strengthening pre-marketing evidence.

  6. Constituting Market Citizenship: Regulatory State, Market Making and Higher Education

    Science.gov (United States)

    Jayasuriya, Kanishka

    2015-01-01

    The paper makes three claims: first that regulatory state making and market making in higher education is intertwined through a project of market citizenship that shapes the "publicness" of higher education. Second, we argue that these projects of market citizenship are variegated and in Australia has taken the form of accommodation--via…

  7. Independent regulatory authorities in European electricity markets

    International Nuclear Information System (INIS)

    Larsen, Anders; Pedersen, Lene Holm; Sorensen, Eva Moll; Olsen, Ole Jess

    2006-01-01

    Liberalisation of the electricity market has taken place in most European countries within the last decade. It is considered a precondition of successful liberalisation to establish so-called independent regulatory authorities. In this article, we compare the status and practice of them in 16 European countries, and discuss the relationship between the organisation of the regulation and the market outcome

  8. Regulatory Competition in Global Financial Markets

    DEFF Research Database (Denmark)

    Ringe, Georg

    2015-01-01

    competition are a reality in today’s global financial market, and the financial sector is different from their traditional fields of application: the ease of arbitrage, the fragility of banking and the risks involved are exceptional. Most importantly, regulatory arbitrage does not or only rarely occurs......The decades-long discussion on the merits of regulatory competition appears in a new light on the global financial market. There are a number of strategies that market participants use to avoid the reach of regulation, in particular by virtue of shifting trading abroad or else relocating activities...

  9. IPTV Market Development and Regulatory Aspects

    DEFF Research Database (Denmark)

    Tadayoni, Reza; Sigurdsson, Halldór Matthias

    2006-01-01

    The aim of this paper is to analyse the development of IPTV technology / market and to discuss major regulatory parameters. A general overview of architectures and the technologies deployed for establishing IPTV services is given and the main stake holder identified, along with, the current service...... architecture, the available content in IPTV platforms, and the current business models. Furthermore the regulatory framework of the TV broadcast and IPTV in Europe is analysed....

  10. Regulatory Competition in Global Financial Markets

    DEFF Research Database (Denmark)

    Ringe, Georg

    2016-01-01

    Regulatory arbitrage in financial markets refers to a number of strategies that market participants use to avoid the reach of regulation, in particular by virtue of moving trading abroad or relocating activities or operations of financial institutions to other jurisdictions. Where this happens...... institutions' excessive risk-taking. If such risk-taking would be judged by market discipline instead of posing a risk to global financial stability, the main downside of regulatory competition could be restrained. Within the boundaries of such a system, competition could then operate and contribute...... their standards solely to attract business and thereby impose externalities on the worldwide financial market by undermining financial stability as a global public good. Policymakers worldwide are experimenting with remedies to respond to the phenomenon. I introduce the importance of an effective special...

  11. Independent regulatory authorities in European electricity market

    DEFF Research Database (Denmark)

    Olsen, Ole Jess; Larsen, Anders; Sørensen, Eva Moll

    2006-01-01

    Liberalisation of the electricity market has taken place in most European countries within the last decade. It is considered a precondition of successful liberalisation to establish so-called independent regulatory authorities. In this article, we compare the status and practice of them in 16...

  12. Energy market opportunities post-Maui

    International Nuclear Information System (INIS)

    Saha, G.

    1995-01-01

    As supply from the Maui and other existing producing fields decline, petroleum explorers and developers need to address the question who will be the indigenous oil and gas customers post Maui? This paper discusses major macro- and micro-environmental trends which will influence likely market opportunities. Two sub-markets are examined. First, what trends impact on current oil and gas customers. Second, what other new customers might arise. The macro-environment trends cover important economic, political, legislation, socio-economic and technical parameters. The micro-environment trends cover energy market structures and pricing parameters. (Author)

  13. 76 FR 34786 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-06-14

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... is hereby given that, on May 25, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ... markets in a large number of stocks and that contribute to price discovery by posting attributable quotes...

  14. Farmers’ Markets: Positive Feelings of Instagram Posts

    Directory of Open Access Journals (Sweden)

    Ladislav Pilař

    2016-01-01

    Full Text Available With increasing consumer requirements, farmers and vendors see the importance of social media as a marketing tool to engage with consumers. In particular, on a more personal level for reasons of brand management. Instagram is becoming increasingly popular as a marketing communication tool. The aim of this paper is to identify areas that users evaluate in terms of positive feelings in connection with farmers’ markets. The results are based on the analysis of the worldwide, and Czech, instagram social network. Instagram posts were identified on the basis of keywords, such as #farmarsketrhy and #farmersmarkets. The results of the study are based on 100,000 contributions on Instagram made by 55,632 users. The analysis contains 1,357,812 ‘unique’ words. The results identified six major areas (1 Healthy (2 Good (3 Great (4 Happy (5 Nice (6 Perfect. An appropriately posted hashtag indicated the positive feelings that were evoked and then assigned to a matching category. The research results are used to identify group characteristics that exert these positive feelings while visiting farmers’ markets. These results can be used to build communications campaigns for farmers’ markets. They can also be used as a basis for further research in defining the behaviour of farmers’ markets visitors, based on cultural differences arising from geographic location.

  15. European Regulatory Framework for Money Market Funds

    OpenAIRE

    Portuese, Aurelien; MacNeil, Iain

    2014-01-01

    Money market funds are widely used by all types of investors, including households, corporate treasurers, pension funds, or insurance companies, who regard money market funds as a ‘safe’ short-term liquid asset class for investing cash. In this case they are proxies to cash deposits. Money market funds are themselves key lenders to issuers of short dated high quality money market instruments. They provide an important source of funding for a variety of institutions such as sovereigns, banks, ...

  16. Progressing towards post-2012 carbon markets

    Energy Technology Data Exchange (ETDEWEB)

    Soeren Luetken, S; Holm Olsen, K

    2011-11-15

    Confronting the end of the first Kyoto Commitment period in 2012 with no agreed outcome for global cooperation on future emission reductions, there is an urgent need to look for new opportunities for public and private cooperation to drive broad-based progress in living standards and keep projected future warming below the politically agreed 2 degrees Celsius. Responding jointly to these global challenges the United Nations environmental Program (UNEP) and its UNEP Risoe Centre (URC) have in cooperation with the Global Green Growth Institute (GGGI) prepared the Perspectives 2011. The publication focuses on the role of carbon markets in contributing to low carbon development and new mechanisms for green growth, as one core area of action to address the challenges noted above. The publication explores in ten articles, how carbon markets at national, regional and global levels can be developed and up-scaled to sustain the involvement of the private sector in leveraging finance and innovative solutions to reduce greenhouse gas emissions. The titles of the ten articles are: 1) Fragmentation of international climate policy - doom or boom for carbon markets?; 2) Perspectives on the EU carbon market; 3) China carbon market; 4) The national context of U.S. state policies for a global commons problem; 5) Mind the gap - the state-of-play of Canadian greenhouse gas mitigation; 6) Role of the UN and multilateral policies in integrating an increasingly fragmented global carbon market; 7) Making CDM work for poor and rich Africa beyond 2012 - a series of dos and don'ts; 8) Voluntary market - future perspectives; 9) Sectoral approaches as a way forward for the carbon market?; 10) The Durban outcome - a post 2012 framework approach for green house gas markets. (LN)

  17. Progressing towards post-2012 carbon markets

    Energy Technology Data Exchange (ETDEWEB)

    Soeren Luetken, S.; Holm Olsen, K.

    2011-11-15

    Confronting the end of the first Kyoto Commitment period in 2012 with no agreed outcome for global cooperation on future emission reductions, there is an urgent need to look for new opportunities for public and private cooperation to drive broad-based progress in living standards and keep projected future warming below the politically agreed 2 degrees Celsius. Responding jointly to these global challenges the United Nations environmental Program (UNEP) and its UNEP Risoe Centre (URC) have in cooperation with the Global Green Growth Institute (GGGI) prepared the Perspectives 2011. The publication focuses on the role of carbon markets in contributing to low carbon development and new mechanisms for green growth, as one core area of action to address the challenges noted above. The publication explores in ten articles, how carbon markets at national, regional and global levels can be developed and up-scaled to sustain the involvement of the private sector in leveraging finance and innovative solutions to reduce greenhouse gas emissions. The titles of the ten articles are: 1) Fragmentation of international climate policy - doom or boom for carbon markets?; 2) Perspectives on the EU carbon market; 3) China carbon market; 4) The national context of U.S. state policies for a global commons problem; 5) Mind the gap - the state-of-play of Canadian greenhouse gas mitigation; 6) Role of the UN and multilateral policies in integrating an increasingly fragmented global carbon market; 7) Making CDM work for poor and rich Africa beyond 2012 - a series of dos and don'ts; 8) Voluntary market - future perspectives; 9) Sectoral approaches as a way forward for the carbon market?; 10) The Durban outcome - a post 2012 framework approach for green house gas markets. (LN)

  18. Social Media Listening for Routine Post-Marketing Safety Surveillance.

    Science.gov (United States)

    Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

    2016-05-01

    Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

  19. Regulation of Telecommunications: The Choice Between Market and Regulatory Failures

    Directory of Open Access Journals (Sweden)

    Dmitrii Trubnikov

    2017-04-01

    Full Text Available Purpose – The paper examines the main regulatory frameworks of the telecommunications industry through the concept of market failure and analyses how and why the policy often leads to undesirable outcomes that might be considered as regulatory failure. Methodology/approach/design – The research uses the EU regulatory framework for electronic communications as a base for the analysis of the main policy objectives through the prism of the market failure theory with an eye to the interests of the main market players in the telecommunications markets. Findings – About any aspect of regulation allows to find ways to create opportunities for some groups of the industry and stifle activity of others. Despite the theory of market failure provides reasonable justifications for regulation of telecommunications markets, it is possible to argue that many of these problems are mainly the consequence of the policy and could be better solved by market mechanisms. Originality/value – The results of the research allow to look at the problems of telecommunications development and issues of the high level of concentration of the telecommunications markets as regulatory formed problems rather than consequences of the inherited industry’s characteristics.

  20. Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

    Science.gov (United States)

    Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

    2016-01-01

    Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

  1. Considering the post-1995 enrichment market

    International Nuclear Information System (INIS)

    Gunter, L.

    1994-01-01

    World demand for uranium enrichment services is likely to grow only a little over the next decade, from the current 28 million separative work units (SWU) per year to 33 MSWU per year. Much of the growth will come from Asia where nuclear generating capacity is still increasing. The current situation of the primary enrichment companies is summarized. The primary Western suppliers, Cogema, United States Enrichment Corporation and Urenco, are competing for increased market share in the USA, Europe and Asia as utilities purchase their post-1995 requirements. Entry of the Russian enrichment company, Tenex, into Western markets has been limited by trade restrictions. As a consequence of disarmament, blended weapons material has resulted in a surplus of low-enriched uranium. Together with over-capacity amongst the primary enrichers this has led to an expectation that reduced prices will be negotiable in the medium term. (3 figures). (UK)

  2. Nuclear regulatory challenges arising from competition in electricity markets

    International Nuclear Information System (INIS)

    2001-01-01

    In recent years a world-wide trend has been developing to introduce competition in electricity markets. As market competition unfolds, it produces a wide range of safety challenges for nuclear power plant operators and regulators. Nuclear regulators must be aware of the potential safety challenges produced and consider whether new regulatory response strategies are warranted. This report describes many of these challenges, their implications and possible regulatory response strategies. The intended audience is primarily nuclear safety regulators, although government authorities, nuclear power plant operators and the general public may also be interested. (author)

  3. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

    Science.gov (United States)

    Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

    2015-06-01

    All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. The Visible Hand: Markets, Politics, and Regulation in Post-Katrina New Orleans

    Science.gov (United States)

    Jabbar, Huriya

    2016-01-01

    In this article Huriya Jabbar examines how the regulatory environment in post-Hurricane Katrina New Orleans has influenced choice, incentives, and competition among schools. While previous research has highlighted the mechanisms of competition and individual choice--the "invisible hand"--and the creation of markets in education, Jabbar…

  5. Drug lag and key regulatory barriers in the emerging markets

    Directory of Open Access Journals (Sweden)

    Harriet Wileman

    2010-01-01

    This work concludes that the overall relative drug lag in the emerging markets has decreased over time and that there are seven key regulatory barriers which need to be targeted in order to make further improvements; ′Western Approval′, local clinical development (LCD, Certificate of Pharmaceutical Product (CPP, Good Manufacturing Practice (GMP, pricing approval, document authentication and harmonisation.

  6. Direct-to-consumer stem cell marketing and regulatory responses.

    Science.gov (United States)

    Sipp, Douglas

    2013-09-01

    There is a large, poorly regulated international market of putative stem cell products, including transplants of processed autologous stem cells from various tissues, cell processing devices, cosmetics, and nutritional supplements. Despite the absence of rigorous scientific research in the form of randomized clinical trials to support the routine use of such products, the market appears to be growing and diversifying. Very few stem cell biologics have passed regulatory scrutiny, and authorities in many countries, including the United States, have begun to step up their enforcement activities to protect patients and the integrity of health care markets.

  7. Post market surveillance in the german medical device sector - current state and future perspectives.

    Science.gov (United States)

    Zippel, Claus; Bohnet-Joschko, Sabine

    2017-08-01

    Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. Regulatory requirements for marketing fixed dose combinations

    Directory of Open Access Journals (Sweden)

    B G Jayasheel

    2010-01-01

    Full Text Available The development of fixed-dose combinations (FDCs is becoming increasingly important from a public health perspective. FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio is safe and effective and when all of the actives contribute to the overall therapeutic effect. Such combinations of drugs are particularly useful in the management of chronic diseases. In addition, there can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects. Additional advantages of FDCs are potentially lower costs of manufacturing compared to the costs of producing separate products administered concurrently, simpler logistics of distribution and reduced development of resistance in the case of antimicrobials. Above all, FDC therapy reduces pill burden and improves medication compliance. Although, FDCs seem to be ideal under certain pre-defined circumstances, if a dosing adjustment is warranted, there may not be an FDC available in the most appropriate strength for the patient and if an adverse drug reaction occurs from using an FDC, it may be difficult to identify the active ingredient responsible for causing the reaction. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945, India states the requirements for marketing approval of various types of FDCs. The same is further elaborated in this article to provide a detailed guidance including the clinical trial requirements. However, the heterogeneity of the therapeutic field makes it difficult to develop a standard guidance document.

  9. 7 CFR 371.5 - Marketing and Regulatory Programs Business Services.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Marketing and Regulatory Programs Business Services... AUTHORITY § 371.5 Marketing and Regulatory Programs Business Services. (a) General statement. Marketing and Regulatory Programs Business Services (MRPBS) plans and provides for the agency's human, financial, and...

  10. Problems in the regulatory policy of the drug market

    Science.gov (United States)

    Miziara, Nathália Molleis; Coutinho, Diogo Rosenthal

    2015-01-01

    OBJECTIVE Analyze the implementation of drug price regulation policy by the Drug Market Regulation Chamber. METHODS This is an interview-based study, which was undertaken in 2012, using semi-structured questionnaires with social actors from the pharmaceutical market, the pharmaceuticals industry, consumers and the regulatory agency. In addition, drug prices were compiled based on surveys conducted in the state of Sao Paulo, at the point of sale, between February 2009 and May 2012. RESULTS The mean drug prices charged at the point of sale (pharmacies) were well below the maximum price to the consumer, compared with many drugs sold in Brazil. Between 2009 and 2012, 44 of the 129 prices, corresponding to 99 drugs listed in the database of compiled prices, showed a variation of more than 20.0% in the mean prices at the point of sale and the maximum price to the consumer. In addition, many laboratories have refused to apply the price adequacy coefficient in their sales to government agencies. CONCLUSIONS The regulation implemented by the pharmaceutical market regulator was unable to significantly control prices of marketed drugs, without succeeding to push them to levels lower than those determined by the pharmaceutical industry and failing, therefore, in its objective to promote pharmaceutical support for the public. It is necessary reconstruct the regulatory law to allow market prices to be reduced by the regulator as well as institutional strengthen this government body. PMID:26083945

  11. 76 FR 41238 - Post Rock Wind Power Project, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2011-07-13

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER11-3959-000] Post Rock Wind Power Project, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for... Rock Wind Power Project, LLC's application for market-based rate authority, with an accompanying rate...

  12. Even Giants Need A Club: Domestic Institutions, Market Size, And Regulatory Influence

    OpenAIRE

    DAVID BACH

    2005-01-01

    This paper show that work on international market regulation has paid insufficient attention to the critical role played by domestic political and regulatory institutions. Existing literature emphasizes the role of market power, determined by market size, in analyzing international regulatory influence. While we do not contest the importance of market power, we introduce the notion of domestic regulatory capacity to capture the domestic institutional side of international market regulation th...

  13. Drug-device combination products: regulatory landscape and market growth.

    Science.gov (United States)

    Bayarri, L

    2015-08-01

    Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

  14. The role of regulatory uncertainty in certificate markets: A case study of the Swedish/Norwegian market

    International Nuclear Information System (INIS)

    Fagiani, Riccardo; Hakvoort, Rudi

    2014-01-01

    Price volatility in green certificate markets reflects uncertainty over future prices, representing a major source of risk for renewable energy generators. Price risk is considered the principal deficiency of this market-based policy since it causes investors to require higher returns. Moreover, investors are exposed to regulatory risk; namely, the risk that a change in the regulation will materially impact the certificate price. Regulatory uncertainty is reflected in market volatility exacerbating certificate price risk. Using an econometric approach, we investigate the role of regulatory changes on price volatility in the Swedish certificate market. The results of our analysis indicate that regulatory changes strongly affect certificate markets, resulting in periods of higher volatility. Moreover, we analyze whether certificate price volatility has changed after creating a joint Swedish/Norwegian market. Results indicate that the ambivalence surrounding the creation of this bigger market led to a period of increased price volatility between 2010 and 2011. Overall, this article brings a better understanding of the role of regulatory uncertainty on certificate markets, and gives evidence for its negative impact in terms of increased price volatility. - Highlights: • Paper analyzes the impact of regulatory changes on certificate price volatility. • Regulatory changes affect market volatility and price risk. • Regulatory uncertainty harms certificate markets. • The bigger Swedish/Norwegian market has not resulted in lower volatility yet

  15. Do regulatory mechanisms promote competition and mitigate market power? Evidence from Spanish electricity market

    International Nuclear Information System (INIS)

    Moutinho, Victor; Moreira, António C.; Mota, Jorge

    2014-01-01

    This paper estimates the relationships between bidding quantities, marginal cost and market power measures in the Spanish wholesale electricity market for two different regulatory periods: 2002–2005 and 2006–2007. Using panel econometric techniques we find differences in the impacts on bidding strategies for both periods. Hence, the marginal cost and the market power measures affect bid and net quantities. The market power measures also suggest that the coefficient is consistently positive and highly significant for both periods. Moreover, the market power and marginal costs have mixed effects according to the models proposed for both periods. In addition, our results point to the effectiveness of the different effects of mitigating the market power in the Spanish electricity market. For the 2006–2007 period, the proposed causal relationships are partially validated by the cointegration results, which assumes there is a significant causality between the Lerner Index and the marginal cost. - Highlights: • Competition and regulation in the Spanish electricity market. • Net supplier and net demander behavior in the spot market. • Panel cointegration methods used: FMOLS, PMG, MG, DFE and DOLS. • The price cap regulation is effective in mitigating market power. • Market power and marginal cost have positive effects on bidding strategies

  16. Bringing nanomedicines to market: regulatory challenges, opportunities, and uncertainties.

    Science.gov (United States)

    Nijhara, Ruchika; Balakrishnan, Krishna

    2006-06-01

    Scientists and entrepreneurs who contemplate developing nanomedicine products face several unique challenges in addition to many of the traditional hurdles of product development. In this review we analyze the major physicochemical, biologic and functional characteristics of several nanomedicine products on the market and explore the question of what made them unique. What made them successful? We also focus on the regulatory challenges faced by nanomedicine product developers. Based on these analyses, we propose the factors that are most likely to contribute to the success of nanomedicine products.

  17. Market segmentation and analysis of Japan's residential post and beam construction market.

    Science.gov (United States)

    Joseph A. Roos; Ivan L. Eastin; Hisaaki Matsuguma

    2005-01-01

    A mail survey of Japanese post and beam builders was conducted to measure their level of ethnocentrism, market orientation, risk aversion, and price consciousness. The data were analyzed utilizing factor and cluster analysis. The results showed that Japanese post and beam builders can be divided into three distinct market segments: open to import...

  18. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    Science.gov (United States)

    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-marketing

  19. Directory of Post-Secondary Retailing and Marketing Vocational Programs.

    Science.gov (United States)

    American Vocational Association, Inc., Washington, DC.

    This directory lists 357 general and 135 special retailing and marketing vocational programs at the post secondary level. Institutions vary somewhat in the identification of general programs; for example, they may be called retailing, merchandising, marketing, mid-management, or distributive education programs. Specialized programs offered by…

  20. Innovations in Post-Marketing Safety Research

    NARCIS (Netherlands)

    Stefánsdóttir, G.

    2012-01-01

    Safety surveillance is important during the entire life cycle of a drug. Pre-marketing trials have been shown to be ineffective in establishing the full safety profile of the drug, mainly due to their relatively small sample size and characteristics of the patients, which are usually younger and

  1. Clinical trials in "emerging markets": regulatory considerations and other factors.

    Science.gov (United States)

    Singh, Romi; Wang, Ouhong

    2013-11-01

    Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country. © 2013.

  2. Correct fair market value calculation needed to avoid regulatory challenges.

    Science.gov (United States)

    Dietrich, M O

    1997-09-01

    In valuing a physician practice for acquisition, it is important for buyers and sellers to distinguish between fair market value and strategic value. Although many buyers would willingly pay for the strategic value of a practice, tax-exempt buyers are required by law to consider only the fair market value in setting a bid price. Valuators must adjust group earnings to exclude items that do not apply to any willing seller and include items that do apply to any willing seller to arrive at the fair market value of the practice. In addition, the weighted average cost of capital (WACC), which becomes the discount rate in the valuation model, is critical to the measure of value of the practice. Small medical practices are assumed to have few hard assets and little long-term debt, and the WACC is calculated on the basis of those assumptions. When a small practice has considerable debt, however, this calculated WACC may be inappropriate for valuing the practice. In every case, evidence that shows that a transaction has been negotiated "at arm's length" should stave off any regulatory challenge.

  3. Cosmetic Surgery: Regulatory Challenges in a Global Beauty Market.

    Science.gov (United States)

    Griffiths, Danielle; Mullock, Alex

    2017-02-28

    The market for cosmetic surgery tourism is growing with an increase in people travelling abroad for cosmetic surgery. While the reasons for seeking cosmetic surgery abroad may vary the most common reason is financial, but does cheaper surgery abroad carry greater risks? We explore the risks of poorly regulated cosmetic surgery to society generally before discussing how harm might be magnified in the context of cosmetic tourism, where the demand for cheaper surgery drives the market and makes surgery accessible for increasing numbers of people. This contributes to the normalisation of surgical enhancement, creating unhealthy cultural pressure to undergo invasive and risky procedures in the name of beauty. In addressing the harms of poorly regulated surgery, a number of organisations purport to provide a register of safe and ethical plastic surgeons, yet this arguably achieves little and in the absence of improved regulation the risks are likely to grow as the global market expands to meet demand. While the evidence suggests that global regulation is needed, the paper concludes that since a global regulatory response is unlikely, more robust domestic regulation may be the best approach. While domestic regulation may increase the drive towards foreign providers it may also have a symbolic effect which will reduce this drive by making people more aware of the dangers of surgery, both to society and individual physical wellbeing.

  4. Design and analysis of post-marketing research.

    Science.gov (United States)

    Zhou, Xiao-Hua Andrew; Yang, Wei

    2013-07-01

    A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

  5. 77 FR 52373 - Self-Regulatory Organizations; NASDAQ Stock Market, LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-08-29

    ...-Regulatory Organizations; NASDAQ Stock Market, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Membership in The NASDAQ Stock Market LLC August 23, 2012. Pursuant to Section... is hereby given that on August [[Page 52374

  6. Switzerland; Financial Sector Assessment Program: Factual Update: Insurance Sector Market and Regulatory Developments

    OpenAIRE

    International Monetary Fund

    2007-01-01

    This paper presents a factual update of the Insurance Core Principles including insurance sector market and regulatory developments for Switzerland. Regulatory reforms since 2003 have updated Switzerland’s regulatory and supervisory regime for the insurance industry to bring it in line with international best practices. The Insurance Supervision Law (ISL) has reoriented the regulatory focus and expanded the regulatory scope to include group/conglomerate supervision, corporate governance, risk...

  7. A critical assessment of the Hong Kong Government's proposed post-2008 regulatory regime for local electricity utilities

    International Nuclear Information System (INIS)

    Woo, Chi-Keung; Horowitz, Ira; Tishler, Asher

    2006-01-01

    In December 2005, the Hong Kong Government issued a 'Consultation Paper on Future Development of the Electricity Markets in Hong Kong: Stage II Consultation,' proposing a post-2008 regulatory regime upon the expiration of the existing regulatory contract between the Hong Kong Government and each of the two local electricity utilities. We assess the proposal using the criteria of safe, reliable, and environmentally friendly service at the lowest rates that will allow the utilities reasonable returns on their investments. We caution that if fully adopted, the highly risky proposal may lead to less-reliable service without the compensating benefits to the environment

  8. Risk management and post-marketing surveillance of CNS drugs.

    Science.gov (United States)

    Henningfield, Jack E; Schuster, Charles R

    2009-12-01

    Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-patient drug abusers, deliberate tampering of drug dosage forms, and criminal behavior associated with diversion. Regulators must consider diverse factors to find the appropriate conditions of approval to minimize unintended consequences while enabling a level of access desired by health care providers and patients. This commentary appears as part of a special issue of Drug and Alcohol Dependence that focuses on risk management and post-marketing surveillance and addresses key issues that pose real-world challenges to pharmaceutical sponsors and regulators in particular. For example, in the U.S., Controlled Substances Act drug scheduling can be considered a risk management strategy but its legal authorities and administrative processes are independent from those of risk management (including Risk Evaluation and Mitigation Strategies or REMS); better harmonization of these approaches is vital from drug development and regulatory perspectives. Risk management would ideally be implemented on a strong science foundation demonstrating that the tools employed to mitigate risks and ensure safe use are effective. In reality, research and evaluation of tools in this area is in its infancy and will necessarily be an evolutionary process; furthermore, there is little precedent for linking interventions and program evolution to unintended consequences such as regional outbreaks of abuse and diversion. How such issues are resolved has the potential to stimulate or stifle innovations in drug development and advance or imperil health care.

  9. State and market in post-reform Brazilian air transportation

    Directory of Open Access Journals (Sweden)

    Cristiano Fonseca Monteiro

    2009-10-01

    Full Text Available The changes that have taken place in Brazilian air transportation following the cycle of “market reforms” have turned this sector into an object of growing interest. This interest, in turn, has led to the emergence of a broad literature on the subject, characterized by the emphasis on an agenda of liberalization and the critique of State activism. The goal of the present article is to promote a confrontation between the different interpretations that have been made, incorporating the contributions of approaches inspired in Economic Sociology and in institutionalist analyses in order to draw attention to the importance that political variables, and the State in particular, have for economic performance. The post-reform context is characterized by an initial moment of greater State activism regarding air transportation, through re-initiation of stricter regulatory mechanisms and the re-opening of channels of dialog between state actors and firms. This is followed by a second moment in which state activism is abandoned, at the same time that the sector demonstrates expressive rates of growth, pushing it beyond its existing capacity and flight support infrastructure. This culminated in the episode known as the “apagão aéreo” (aerial black out Analysis of testimonies of state and private sector actors regarding the “blackout” enables us to identify the flaws in the responsible state apparatus as one of the factors that led to the “blackout”. Our conclusions draw attention to the importance of taking political factors into consideration, and particularly the role of the State, in the development of air transportation in Brazil. Keywords: commercial aviation, politics and economics, regulation, Economic Sociology, Historical Institutionalism.

  10. Ontario's power market post November 11

    International Nuclear Information System (INIS)

    Murphy, P.

    2003-01-01

    This paper provides a review of Ontario's first year with an open electricity market. The year 2002 to 2003 had record energy demands with challenges on the supply side. In particular, generation availability was below expectations during the summer months. This demonstrated that price predictability and volatility needs to be addressed and investment in new power generation is needed in Ontario. Ontario demand forecasts outpace supply for the long term outlook. In addition, most of Ontario's generating plants are aging and will soon exceed their nominal service life, requiring major refurbishment or replacement. Decisions are needed now on the future of coal in Ontario's generation mix. It was also noted that transmission reinforcements are needed in the Greater Toronto Area (GTA). In the short term, consumers can expect delays in return to service of nuclear units, forced extensions to planned outages, and reduced outlook for energy from hydroelectric resources. It was noted that Ontario will continue to rely on imports, although emergency generation is being installed. 5 figs

  11. Multiple post-transcriptional regulatory mechanisms in ferritin gene expression

    International Nuclear Information System (INIS)

    Mattia, E.; Den Blaauwen, J.; Van Renswoude, J.; Ashwell, G.

    1989-01-01

    The authors have investigated the mechanisms involved in the regulation of ferritin biosynthesis in K562 human erythroleukemia cells during prolonged exposure to iron. They show that, upon addition of hemin (an efficient iron donor) to the cell culture, the rate of ferritin biosynthesis reaches a maximum after a few hours and then decreases. During a 24-hr incubation with the iron donor the concentrations of total ferritin heavy (H) and light (L) subunit mRNAs rise 2- to 5-fold and 2- to 3-fold, respectively, over the control values, while the amount of the protein increases 10- to 30-fold. The hemin-induced increment in ferritin subunit mRNA is not prevented by deferoxamine, suggesting that it is not directly mediated by chelatable iron. In vitro nuclear transcription analyses performed on nuclei isolated from control cells and cells grown in the presence of hemin indicate that the rates of synthesis of H- and L-subunit mRNAs remain constant. They conclude that iron-induced ferritin biosynthesis is governed by multiple post-transcriptional regulatory mechanisms. They propose that exposure of cells to iron leads to stabilization of ferritin mRNAs, in addition to activation and translation of stored H-and L-subunit mRNAs

  12. Towards a single European electricity market. A structured approach to regulatory mode decision-making

    International Nuclear Information System (INIS)

    De Jong, H.M.

    2009-01-01

    This study focuses on the processes through which the rules and regulations that govern European electricity markets - and inherently, their integration process - are established. So far, European policy makers have largely followed a 'trial-and-error' approach to finding an appropriate regulatory mode (process) for dealing effectively with market integration issues. This unstructured approach to regulatory mode selection leads to several problems: - Today's trial-and-error strategy of shifting from one regulatory mode to another is time-consuming. - In the regulatory mode selection process, certain key principles of good governance are insufficiently considered. - European regulatory processes are experienced as vague, intransparent, and illegitimate by 'outside' stakeholders. This study develops a 'structured approach to regulatory mode decision-making' (STARMODE) based on the theory of decision modelling in policy management and a case study exploring three key market integration issues in the field of electricity markets: interconnector investment, congestion management and market transparency. The main objective is to present a systematic and comprehensive framework for analysing and improving regulatory mode decision-making in the context of the European Union, focusing on electricity market integration. The STARMODE approach is generally applicable to (and relevant for) European market integration issues in industries characterized by a natural monopoly and/or an essential service. The approach may also contribute to national regulatory mode decision-making and multi-state decision-making in other continents.

  13. Subcontracting, Posted Migrants and Labour Market Segmentation in Finland

    NARCIS (Netherlands)

    Lillie, Nathan

    Using evidence from the shipbuilding and construction industries in Finland, this article shows how trade union responses to the introduction of migrant workers can be conditioned by product markets. Growing numbers of posted workers, or intra-European Union work migrants employed via transnational

  14. Preferred supplier contracts in post-patent prescription drug markets.

    Science.gov (United States)

    Blankart, Carl Rudolf; Stargardt, Tom

    2016-02-22

    In recent years, the expiration of patents for large drug classes has increased the importance of post-patent drug markets. However, previous research has focused solely on patent drug markets. In this study, the authors evaluate the influence of preferred supplier contracts, the German approach to tendering, in post-patent drug markets using a hierarchical market share attraction model. The authors find that preferred supplier contracts are a powerful strategic instrument for generic manufacturers in a highly competitive environment. They quantify the effects of signing a preferred supplier contract and show that brand-name manufacturers are vulnerable to tendering. Therefore, brand-name manufacturers should readjust their strategies and consider including preferred supplier contracts in their marketing mix. In addition, the authors employ a simulation to demonstrate that a first-mover advantage might be gained from signing a preferred supplier contract. Furthermore, their results can be used as a blueprint for decision makers in the pharmaceutical industry to assess the market share effects of different contracting strategies regarding preferred supplier contracts.

  15. 76 FR 3188 - Self-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-01-19

    ...-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Routing Fees for the NASDAQ Options Market January 12, 2011. Pursuant to... is hereby given that on January 6, 2011, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange...

  16. 76 FR 78325 - Self-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-12-16

    ...-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a Proposed... November 30, 2011. The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and... Change The NASDAQ Stock Market LLC proposes to amend Rule 7056 entitled ``NASDAQ Options Fee Disputes...

  17. Enforcing Margin Squeeze Ex Post Across Converging Telecommunications Markets

    DEFF Research Database (Denmark)

    Bergqvist, Christian; Townsend, John

    , delay profitability or limit their ability to remain or expand on markets. However, traditional market definitions are being challenged by (1) the technological convergence of services and (2) innovative product offerings taking advantage of this convergence. Consumers now routinely purchase a bundle...... and innovation present both theoretical and practical difficulties for assessing “muddled margins” on telecoms markets. New and different enforcement approaches to exclusion will have to be formulated within the Article 102 framework and tested in the Courts. This may even require abstaining from applying...... Article 102 TFEU during material periods of convergence, and confining ex post enforcement activity to sector regulation, even when this is inferior for safeguarding effective competition....

  18. Some Implications of New Regulatory Measures for Euro Area Money Markets

    OpenAIRE

    Doran, David; Kirrane, Caroline; Masterson, Mary

    2014-01-01

    A number of banking and financial market regulations have been proposed in response to the financial crisis; in particular the Basel III solvency and liquidity rules. These enhanced regulatory standards intend to ensure that banks and banking systems are significantly more resilient in the future than was the case in the run-up to the financial crisis. However, there have been concerns that the extent and range of the new regulatory measures may lead to unintended shifts in market behaviour. ...

  19. Learning by the Market: Regulatory Regionalism, Bologna, and Accountability Communities

    Science.gov (United States)

    Jayasuriya, Kanishka

    2010-01-01

    Over the last two decades institutions of higher education have been subject to new modes of regulatory governance. This essay applies a "regulatory lens" to higher education governance with a view to understanding the sometimes contradictory relationship between the globalisation and regionalisation of higher education and the…

  20. Regulatory theory: commercially sustainable markets rely upon satisfying the public interest in obtaining credible goods.

    Science.gov (United States)

    Warren-Jones, Amanda

    2017-10-01

    Regulatory theory is premised on the failure of markets, prompting a focus on regulators and industry from economic perspectives. This article argues that overlooking the public interest in the sustainability of commercial markets risks markets failing completely. This point is exemplified through health care markets - meeting an essential need - and focuses upon innovative medicines as the most desired products in that market. If this seemingly invulnerable market risks failure, there is a pressing need to consider the public interest in sustainable markets within regulatory literature and practice. Innovative medicines are credence goods, meaning that the sustainability of the market fundamentally relies upon the public trusting regulators to vouch for product quality. Yet, quality is being eroded by patent bodies focused on economic benefits from market growth, rather than ensuring innovatory value. Remunerative bodies are not funding medicines relative to market value, and market authorisation bodies are not vouching for robust safety standards or confining market entry to products for 'unmet medical need'. Arguably, this failure to assure quality heightens the risk of the market failing where it cannot be substituted by the reputation or credibility of providers of goods and/or information such as health care professionals/institutions, patient groups or industry.

  1. Analysing success of regulatory policy transfers: Evidence from Turkish energy markets

    International Nuclear Information System (INIS)

    Dastan, Seyit Ali

    2011-01-01

    Economic regulation of public utilities has become a worldwide phenomenon with the preceding privatisation stream. It is questionable to transfer regulatory models hastily without customising the policy options or introducing necessary institutional reforms enabling the achievement of expected results of regulatory reform. Institutional configuration of a country affects credibility of regulatory commitments, quality of regulatory design, and way of policy transfer. Turkey’s energy market regulation experience confirms the decisive role of institutions in shaping the regulatory framework. - Highlights: ► The last quarter of the 20th century witnessed public sector reforms all over the world. ► The British model of utility regulation swept globally. ► In Turkey’s adoption of the utility regulation model, different factors affected in various ways. ► Higher political stability and regulatory experience provide faith in the regulatory framework.

  2. 77 FR 50191 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Instituting Proceedings To...

    Science.gov (United States)

    2012-08-20

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Instituting Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Change To Establish ``Benchmark Orders'' Under NASDAQ Rule 4751(f) August 14, 2012. I. Introduction On May 1, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange...

  3. 78 FR 3928 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Disapproving Proposed Rule...

    Science.gov (United States)

    2013-01-17

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Disapproving Proposed Rule Change To Establish ``Benchmark Orders'' Under NASDAQ Rule 4751(f) January 11, 2013. I. Introduction On May 1, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and Exchange Commission...

  4. GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

    OpenAIRE

    Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

    2017-01-01

    Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

  5. Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

    Science.gov (United States)

    Cohen, Stanley; Curtis, Jeffrey R; DeMasi, Ryan; Chen, Yan; Fan, Haiyun; Soonasra, Arif; Fleischmann, Roy

    2018-06-01

    Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5 mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.

  6. Emerging Markets: Theory & Practice / Turkey’s Reforms Post 2001 Crisis

    Directory of Open Access Journals (Sweden)

    Duygu Uckun

    2010-01-01

    Full Text Available The global financial downturn of 2001 affected broad swaths of the increasingly interconnected global economy. The global effects of the economic downturn in the U.S. in 2008 showed that decoupling had not occurred to the extent many thought, and showed that indeed emerging market countries, including Turkey, were not immune from economic trouble in America. This paper addresses the question, whether the fiscal, financial, and regulatory reforms in Turkey after the 2001 economic crisis cushion the global financial crisis world is facing toward the end of the decade. In doing so we analyze the policies implemented by Turkey before and after the 2001 global economic crisis and identify the successes as well as failures of those reforms. The results of our research show that despite significant reforms in key economic and regulatory areas in the post-2001 crisis period, vulnerabilities remained; especially concerning the large current account deficit, volatility of exchange rates, increased private sector indebtedness, and persistent unemployment. These vulnerabilities will be visible in the deteriorating liquidity conditions in the global financial markets. We conclude by recommending infrastructure, education and health spending as well as restructuring of the economy to further attract FDI and avoid reliance on speculative foreign capital in order to achieve a more balanced and sustained growth in the long run.

  7. Regulatory T Cells in Post-stroke Immune Homeostasis.

    Science.gov (United States)

    Liesz, Arthur; Kleinschnitz, Christoph

    2016-08-01

    The secondary neuroinflammatory response has come into focus of experimental stroke research. Immunological mechanisms after acute stroke are being investigated in the hope to identify novel and druggable pathways that contribute to secondary infarct growth after stroke. Among a variety of neuroimmunological events after acute brain ischemia, including microglial activation, brain leukocyte invasion, and secretion of pro-inflammatory factors, lymphocytes have been identified as the key leukocyte subpopulation driving the neuroinflammatory response and contributing to stroke outcome. Several studies have shown that pro-inflammatory lymphocyte subpopulations worsen stroke outcome and that inhibiting their invasion to the injured brain is neuroprotective. In contrast to the effector functions of pro-inflammatory lymphocytes, regulatory T cells (Treg) are critically involved in maintaining immune homeostasis and have been characterized as disease-limiting protective cells in several inflammatory conditions, particularly in primary inflammatory diseases of the central nervous system (CNS). However, due to the complex function of regulatory cells in immune homeostasis and disease, divergent findings have been described for the role of Treg in stroke models. Emerging evidence suggests that this discrepancy arises from potentially differing functions of Treg depending on the predominant site of action within the neurovascular unit and the surrounding inflammatory milieu. This article will provide a comprehensive review of current findings on Treg in brain ischemia models and discuss potential reasons for the observed discrepancies.

  8. Post-neoliberal electricity market 're-reforms' in Argentina. Diverging from market prescriptions?

    International Nuclear Information System (INIS)

    Haselip, James; Potter, Clive

    2010-01-01

    This paper focuses upon the policy and institutional change that has taken place within the Argentine electricity market since the country's economic and social crisis of 2001/2. As one of the first less developed countries (LDCs) to liberalise and privatise its electricity industry, Argentina has since moved away from the orthodox market model after consumer prices were frozen by the Government in early 2002 when the national currency was devalued by 70%. Although its reforms were widely praised during the 1990s, the electricity market has undergone a number of interventions, ostensibly to keep consumer prices low and to avert the much-discussed energy 'crisis' caused by a dearth of new investment combined with rising demand levels. This paper explores how the economic crisis and its consequences have both enabled and legitimised these policy and institutional amendments, while drawing upon the specifics of the post-neoliberal market 're-reforms' to consider the extent to which the Government appears to be moving away from market-based prescriptions. In addition, this paper contributes to sector-specific understandings of how, despite these changes, neoliberal ideas and assumptions continue to dominate Argentine public policy well beyond the postcrisis era. (author)

  9. The Greek Electricity Market Reforms: Political and Regulatory Considerations

    International Nuclear Information System (INIS)

    Danias, Nikolaos; Kim Swales, John; McGregor, Peter

    2013-01-01

    The paper tracks the evolution of the Greek electricity market since the beginning of the liberalization process. Its progress is benchmarked against the criteria suggested by Littlechild (2006b). The Littlechild framework highlights key remaining deficiencies in the stances and policies adopted which need to be resolved in order for liberalization to proceed successfully. The focus is on the agendas of the Greek government, other domestic political forces and the European Union. A central requirement is the clear commitment to liberalization by the Greek government. In particular the government needs to give up political control over the previous vertically integrated, state-controlled electricity firm, Public Power Company (PPC), and allow more decision making powers and genuine independence to the market regulator. Liberalization is rendered more difficult by the present financial and economic crisis in Greece. - Highlights: • Greek electricity market liberalization is benchmarked against the Littlechild standard electricity market reform model. • Although the majority of the model requirements are met, liberalization in Greece is only partially successful. • Some elements of liberalization are qualitatively more significant than others. • More fundamental political economy issues need to be addressed in order for the liberalization to progress. • Financial crisis in Greece adds extra challenges

  10. Regulatory reform in the Indonesian Natural Gas Market

    NARCIS (Netherlands)

    Hutagalung, Aldi; Arentsen, Maarten; Lovett, Jon

    2011-01-01

    This paper analyses the problems and dilemmas Indonesia is facing in the upstream and downstream segments of the gas market and the remedies suggested and practiced in Indonesia to mitigate the problems. Indonesia is a country gifted with natural resources, including natural gas and oil. The

  11. Regulatory barriers for activating flexibility in the Nordic-Baltic electricity market

    DEFF Research Database (Denmark)

    Bergaentzlé, Claire; Skytte, Klaus; Soysal, Emilie Rosenlund

    2017-01-01

    to flexibility. We find that the most restrictive barriers against flexibility are emitted by public authorities as part of broader policy strategies. Overall, we find that current regulatory and market framework conditions do not hinder flexibility. However, despite that, flexibility remains limited due......, load adjustment or to a greater coupling to other energy sectors. In this paper, we identify the framework conditions that influence the provision of VRE-friendly flexibility in the Nordic and Baltic electricity sector, i.e., the market and regulatory settings that act as drivers or barriers...... to a lack of coherent instruments intended to both the demand and supply-side to effectively act flexibly....

  12. Pediatric post-marketing safety systems in North America: assessment of the current status.

    Science.gov (United States)

    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.

  13. A Post-Modern Portfolio Management Approach on CEE Markets

    Directory of Open Access Journals (Sweden)

    Marcela-Daniela Todoni

    2015-01-01

    Full Text Available In this paper we apply two methods based on the Post-Modern Portfolio Management approach to study the risk-adjusted return of 5 major indices from emerging markets in Central and Eastern Europe during the period 2008-2013 on daily data. First, we involve the Sortino ratio. Secondly we propose an alternative method to the Sortino ratio for calculating the risk-adjusted return using a “multipliers method” to determine a global measure of risk. The Sortino ratio is used to score a portfolio's risk-adjusted returns relative to an investment target using downside risk and it measures the risk-adjusted return of an investment asset, portfolio or strategy. Our proposed alternative method is using the same logic and frame structure as Sortino ratio. However instead of downside risk we use the global risk calculated using multipliers. This is due to the fact that Sortino ratio does not distinguish between sub-cases possible – unrealized return area and loss area (negative return. Because of these we believe that it would be necessary a new method which to refine the results and take and into account the three areas. Our dataset includes 5 emerging markets: Romania (BET, Hungary (BUX, Czech Republic (PX, Bulgaria (SOFIX and Poland (WIG. For each of them we estimate the Sortino ratio of length windows 7, 14, 42 and 10, 21, 60. We used two variants for each target return, namely 2% and 5%. We consider Germany as a benchmark. After estimating the Sortino ratio and global risk calculated using “multipliers method”, we conducted a parallel analysis between Sortino ratio and the proposed alternative method. We split the analysis time span in two sub-periods, 2008-2010 and 2011-2013. As known, the higher the Sortino ratio, the better the risk-adjusted performance. The risk-adjusted return is influenced by the used target return and the used window. Analyzed data reveals that in case of Sortino ratio, Hungary has the best results and on the other side

  14. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

    Science.gov (United States)

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

  15. Sustainable Markets Investment Briefings: the regulatory taking doctrine

    Energy Technology Data Exchange (ETDEWEB)

    Cotula, Lorenzo

    2007-08-15

    This is the third of a series of briefings which discuss the sustainable development issues raised by legal arrangements for the protection of foreign investment. The briefings are based on legal research by IIED and its partners. The goal is to provide accessible but accurate information for human rights, development and environmental organisations working on issues raised by foreign investment in low- and middle-income countries. Briefing 3 introduces one of the most controversial legal doctrines of investment law – 'regulatory taking' – and sets out its implications for sustainable development.

  16. [Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

    Science.gov (United States)

    Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

    2018-01-01

     Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

  17. Regulatory Sanctions and Reputational Damage in Financial Markets

    OpenAIRE

    Armour, John; Mayer, Colin; Polo, Andrea

    2010-01-01

    We study the impact of the announcement of enforcement of financial and securities regulation by the UK’s Financial Services Authority and London Stock Exchange on the market price of penalized firms. Since these agencies do not announce enforcement until a penalty is levied, their actions provide a uniquely clean dataset on which to examine reputational effects. We find that reputational sanctions are very real: their stock price impact is on average ten times larger than the financial penal...

  18. 76 FR 55988 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-09-09

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...,\\2\\ notice is hereby given that, on August 31, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or... perfect the mechanism of a free and open market and a national market system, and, in general to protect...

  19. 77 FR 4610 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-01-30

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on January 11, 2012, The NASDAQ Stock Market LLC (``Nasdaq'') filed with the Securities... impediments to and perfect the mechanism of a free and open market and a national market system, and, in...

  20. 75 FR 78789 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-12-16

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... is hereby given that on December 9, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange... market and a national market system, and, in general, to protect investors and the public interest. The...

  1. 75 FR 10541 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-03-08

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on February 24, 2010, The NASDAQ Stock Market LLC (``Nasdaq'') filed with the... impediments to and perfect the mechanism of a free and open market and a national market system, and, in...

  2. 75 FR 43591 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-07-26

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... given that on June 30, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or the ``Exchange'') filed with the... mechanism of a free and open market and a national market system, and, in general, to protect investors and...

  3. 76 FR 48186 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-08-08

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... is hereby given that, on July 27, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ... NASDAQ Stock Market and the NASDAQ Options Market. Currently, a member that provides shares of liquidity...

  4. Mapping out the regulatory environment and its interaction with land and property markets

    International Nuclear Information System (INIS)

    Adams, David

    2008-01-01

    The purpose of this paper is to explain how the regulatory environment created by planning and building regulations interacts with land and property markets. Since this regulatory environment operates as a form of intervention within property markets in general and the development process in particular, it is essential first to understand the nature, structure and operation of land and property markets. These are covered in the first section. The second section identifies the aims and components of the planning system and building regulations. From this basis, four broad types of policy intervention are reviewed in the third section. These cover policies that seek to shape, regulate or stimulate market activity, and those that aim to build state or market capacity to produce desired outcomes. The final section uses the private residential development process as a case study to explore the extent to which state intervention can influence producer-consumer relationships in one important market sector. The paper argues that effective intervention in land and property markets requires the creation of a broad range of policy tools and their appropriate deployment to suit particular market circumstances. (author)

  5. The New Electricity Market of Singapore : regulatory framework, market power and competition

    International Nuclear Information System (INIS)

    Chang, Y.

    2007-01-01

    This study examines whether the New Electricity Market of Singapore (NEMS) is functioning at a workable level of competition. The generation market of the NEMS appears highly concentrated by a four-firm concentration ratio or the Herfindahl-Hirschman Index. However, other measures of market power present that the NEMS is working at close to a competitive market. First, there seems to be a number of effective competitors in the market. Second, Supply Margin Assessment and Residual Supply Index support that the market is competitive though there are some possibilities in which the largest generator or a few large generators jointly could still have market power. Third, the Lerner Index of the NEMS shows that the generation market is fairly competitive and the Lerner Index adjusted with an industry level price elasticity of demand implies that there has not been much exercise of market power. Finally, vesting contracts - a contractual obligation of a specified quantity of electricity supply to the market - have appeared to be a strong and effective tool to mitigate market power in the NEMS. The vesting contracts are considered the force behind the lowering in the average Uniform Singapore Electricity Price and the Lerner Index in 2004. [Author

  6. The New Electricity Market of Singapore: Regulatory framework, market power and competition

    International Nuclear Information System (INIS)

    Chang Youngho

    2007-01-01

    This study examines whether the New Electricity Market of Singapore (NEMS) is functioning at a workable level of competition. The generation market of the NEMS appears highly concentrated by a four-firm concentration ratio or the Herfindahl-Hirschman Index. However, other measures of market power present that the NEMS is working at close to a competitive market. First, there seems to be a number of effective competitors in the market. Second, Supply Margin Assessment and Residual Supply Index support that the market is competitive though there are some possibilities in which the largest generator or a few large generators jointly could still have market power. Third, the Lerner Index of the NEMS shows that the generation market is fairly competitive and the Lerner Index adjusted with an industry level price elasticity of demand implies that there has not been much exercise of market power. Finally, vesting contracts-a contractual obligation of a specified quantity of electricity supply to the market-have appeared to be a strong and effective tool to mitigate market power in the NEMS. The vesting contracts are considered the force behind the lowering in the average Uniform Singapore Electricity Price and the Lerner Index in 2004

  7. Market redesign and regulatory change : how companies doing business in Alberta's power markets will be affected

    International Nuclear Information System (INIS)

    Runge, C.

    2003-01-01

    The Power Pool of Alberta (PPA) began its operations in 1996 based on a model with a single price set based on day ahead offers/bids and real time dispatch. The Electric Utilities Act was amended in 1998 and direct sales were permitted in 1999. The Power Purchase Arrangement Auction was implemented in 2000. Significant events took place in 2001, including: (1) retail competition, (2) PPAs began operations, (3) restrictions on direct sales were removed, (4) forward exchange operation, and (5) ancillary services market. In 2002, the Market Achievement Plan II was implemented and government industry structure was reviewed. There are several considerations regarding market redesign, such as day ahead market, capacity market, congestion management, and Northwest Regional Transmission Organization (RTO West). The role of the International Standard Organization (ISO) was discussed, with reference to the Independent System Operator, Independent Market Operator, and Transmission and Market Planner. Redesign must involve all participants and include informed, phased in changes

  8. Towards a single European electricity market : A structured approach to regulatory mode decision-making

    NARCIS (Netherlands)

    De Jong, H.M.

    2009-01-01

    This study focuses on the processes through which the rules and regulations that govern European electricity markets - and inherently, their integration process - are established. So far, European policy makers have largely followed a 'trial-and-error' approach to finding an appropriate regulatory

  9. 76 FR 76472 - Self-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-12-07

    ... at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the... facility or system which NASDAQ operates or controls. \\7\\ 15 U.S.C. 78f. \\8\\ 15 U.S.C. 78f(b)(4). NASDAQ... Release No. 61358 (January 14, 2010), 75 FR 3594 (January 21, 2010) (Concept Release on Equity Market...

  10. Strategies of bringing drug product marketing applications to meet current regulatory standards.

    Science.gov (United States)

    Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

    2015-08-01

    In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

  11. A Process Perspective on Regulation: A Grounded Theory Study into Regulatory Practice in Newly Liberalized Network-Based Markets

    NARCIS (Netherlands)

    Ubacht, J.

    The transition from a former monopolistic towards a more competitive market in
    newly liberalized network-based markets raises regulatory issues. National Regulatory Authorities (NRA) face the challenge to deal with these issues in order to guide the transition process. Although this transition

  12. Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

    Science.gov (United States)

    Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

    2018-01-15

    Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2,345 post-marketing trials; 1,362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials (range 8-530) and overall population to be enrolled per trial (1-8,381). Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3 to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. © 2017 UICC.

  13. Geothermal prospects in British Columbia: Resource, market and regulatory aspects

    International Nuclear Information System (INIS)

    Ghomshei, M.M.; Brown, T.L.S.; MacRae, J.M.

    1992-01-01

    British Columbia is host to about 15 young volcanic centres and 60 hot springs, all evidence of presence of geothermal resources. Most high-grade geothermal prospects in British Columbia are located along 3 volcanic belts in the south-western region of the province. It is estimated that a minimum of 800 MWe can be generated from the known prospects in this region. Significant low-grade geothermal resources exist in several provincial regions. Market applications consistent with the geothermal resources known and expected to occur in British Columbia include electrical generation, process and other direct heat uses and recreation. Leasing, exploration and development operations for high-grade geothermal resources are addressed by the British Columbia open-quotes Geothermal Resources Actclose quotes which defines geothermal resources and reserves all rights to the Crown in the right of the Province

  14. Regulatory design for RES-E support mechanisms: Learning curves, market structure, and burden-sharing

    International Nuclear Information System (INIS)

    Batlle, C.; Pérez-Arriaga, I.J.; Zambrano-Barragán, P.

    2012-01-01

    Drawing from relevant experiences in power systems around the world, this paper offers a review of existing policy support mechanisms for RES-E, with a detailed analysis of their regulatory implications. While recent studies provide an account of current RES-E support systems, in this paper we focus on some of the impacts these mechanisms have on the overall energy market structure and its performance. Given the rising importance of RES-E in systems everywhere, these impacts should no longer be overlooked. - Highlights: ► This paper offers a critical review of RES-E support mechanisms and their regulatory implications. ► The discussion focuses on how the different schemes impact the performance of the energy markets. ► We propose to redesign of current RES-E mechanisms to optimize incentives and market performance. ► Our recommendation is also to gradually move from price-based mechanisms to auctions.

  15. Uranium and nuclear market, the horizon post-Fukushima

    International Nuclear Information System (INIS)

    Lelièvre, F.

    2014-01-01

    Post-Fukushima, most countries have confirmed the importance of nuclear in their energy mix. We are seeing a level of new reactor construction unparalleled in decades with 61 nuclear power plants under construction and 5 plants under completion around the world. Global nuclear capacity is expected to increase by 50% over the next two decades. And more reactors mean more demand for uranium. However, uranium industry is currently grappling with near-term challenges, particularly in the form of depressed uranium prices. Recently several uranium producers announced production delays or cancellations in response to low prices, including major suppliers. As the current price levels, including long-term prices, are not sufficient to stimulate new production, future supplies are in question due to the long-lead nature of uranium mine development. Despite the near- to medium-term issues of our industry, the fundamentals of the uranium market remain strong over the long term - and these are the drivers of the Areva’s mining growth strategy over the coming years. (author)

  16. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    Directory of Open Access Journals (Sweden)

    Ross JS

    2015-05-01

    Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

  17. Post-project market review as a tool for stimulating commercialisation of knowledge creation projects

    NARCIS (Netherlands)

    Bout, L.Y.; Lombaers, J.H.M.; Constantinides, E.; Weerd-Nederhof, P.C. de

    2009-01-01

    Post-Project Reviews are mainly used as a tool to improve organisational learning (Busby, 1999; von Zedtwitz, 2002). However, the concept of post-project review can also be used as a tool to identify new market potential and to hand over technical knowledge from technical to marketing personnel (von

  18. Post-Project Market Review as a Tool for Stimulating Commercialisation of Knowledge Creation Projects

    NARCIS (Netherlands)

    Bout, Y.; Lombaers, Jaap H.M.; Constantinides, Efthymios; Fisscher, O.A.M.; de Weerd-Nederhof, Petronella C.; Oakey, R.; Groen, A.; Cook, G.; van der Sijde, P.

    2009-01-01

    Post-Project Reviews are mainly used as a tool to improve organisational learning (Busby, 1999; von Zedtwitz, 2002). However, post-project reviews can also be used as a tool to identify new market potential and to hand over technical knowledge from technical to marketing personnel (von Zedtwitz,

  19. Low-rank coal study. Volume 4. Regulatory, environmental, and market analyses

    Energy Technology Data Exchange (ETDEWEB)

    1980-11-01

    The regulatory, environmental, and market constraints to development of US low-rank coal resources are analyzed. Government-imposed environmental and regulatory requirements are among the most important factors that determine the markets for low-rank coal and the technology used in the extraction, delivery, and utilization systems. Both state and federal controls are examined, in light of available data on impacts and effluents associated with major low-rank coal development efforts. The market analysis examines both the penetration of existing markets by low-rank coal and the evolution of potential markets in the future. The electric utility industry consumes about 99 percent of the total low-rank coal production. This use in utility boilers rose dramatically in the 1970's and is expected to continue to grow rapidly. In the late 1980's and 1990's, industrial direct use of low-rank coal and the production of synthetic fuels are expected to start growing as major new markets.

  20. Global regulatory framework for production and marketing of crops biofortified with vitamins and minerals.

    Science.gov (United States)

    Mejia, Luis A; Dary, Omar; Boukerdenna, Hala

    2017-02-01

    Biofortification of crops is being introduced in several countries as a strategy to reduce micronutrient deficiencies. Biofortified products, with increased contents of micronutrients, are currently produced by conventional plant breeding, genetic modification, or nutrient-enhanced fertilization. Corn, rice, wheat, beans, pearl millet, sweet potato, and cassava have been biofortified with increased contents of provitamin A carotenoids, iron, or zinc. However, regulatory considerations are rare or nonexistent. The objective of this paper is to review the regulatory framework for production and marketing of biofortified crops in countries that have adopted this strategy. The information was identified using Internet search engines and websites of health and nutrition organizations and nongovernmental organizations and by consulting scientists and government authorities. Thus far, biofortified products introduced in Latin America, Africa, and Asia have been produced only by conventional breeding. Cultivars using other techniques are still under testing. The production and marketing of these products have been conducted without regulatory framework and under limited government control or regulatory guidance. Nevertheless, some countries have integrated biofortified crops into their nutrition agendas. Although improvements by conventional breeding have not been subject to regulations, when biofortification becomes expanded by including other techniques, an appropriate regulatory framework will be necessary. © 2016 New York Academy of Sciences.

  1. Marketing Communications in the Post-Advertising Era.

    Science.gov (United States)

    Dilenschneider, Robert L.

    1991-01-01

    Challenges four commonly held myths about advertising and marketing effectiveness. Establishes the framework for a more comprehensive program of marketing communication involving traditional public relations, advertising, sales promotion, special events, along with new uses for public affairs work in marketing. (MG)

  2. 75 FR 12318 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-03-15

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Pricing for Option Orders Routed to Away Markets March 5, 2010. Pursuant...,\\2\\ notice is hereby given that on March 2, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or...

  3. 76 FR 40971 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-07-12

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... June 27, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed with the Securities... NASDAQ Options Market (``NOM'') to amend Chapter VI, Trading Systems, Section 11, Order Routing, to...

  4. 75 FR 21069 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-04-22

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Fees for Members Using the NASDAQ Market Center April 16, 2010. Pursuant to... is hereby given that on April 13, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

  5. 76 FR 27699 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-05-12

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... given that on April 28, 2011 The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed with the... inside market and the midpoint for stocks at this price level is likely to be extremely small, and...

  6. 75 FR 9632 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-03-03

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Pricing for the NASDAQ Options Market (``NOM'') February 24, 2010. Pursuant... thereunder,\\2\\ notice is hereby given that, on January 27, 2010, The NASDAQ Stock Market LLC (``NASDAQ...

  7. 76 FR 12178 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-03-04

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Offer Market Data to the Public at No Charge February 25, 2011. Pursuant to Section... hereby given that, on February 24, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ...

  8. 76 FR 46869 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-08-03

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... that, on July 22, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed with the...'') a proposal for the NASDAQ Options Market (``NOM'') to amend Chapter VI, Trading Systems, Section 1...

  9. 77 FR 10794 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-02-23

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... February 13, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and... Change The NASDAQ Stock Market LLC proposes to modify Chapter XV, Section 2, governing pricing for NASDAQ...

  10. 75 FR 18932 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-04-13

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Fees for Members Using the NASDAQ Market Center April 6, 2010. Pursuant to... is hereby given that on March 30, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

  11. 75 FR 29596 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-05-26

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Fees for Members Using the NASDAQ Market Center May 19, 2010. Pursuant to... is hereby given that on May 14, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

  12. 76 FR 34783 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-06-14

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...,\\2\\ notice is hereby given that on May 26, 2011, The NASDAQ Stock Market LLC (``NASDAQ'' or... telecommunication, inter-cabinet connectivity, connectivity to NASDAQ and market data connectivity related to an...

  13. 77 FR 19044 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-03-29

    ...-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of..., 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and Exchange... halt, there is a 15-minute Display-Only Period during which market participants may enter quotes and...

  14. 78 FR 68122 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-11-13

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on October 28, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed... Section 2 governing pricing for NASDAQ members using the NASDAQ Options Market (``NOM''), NASDAQ's...

  15. 78 FR 71018 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-11-27

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on November 8, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange''), filed... service. This new low latency service decreases the time individual orders are processed and market data...

  16. 76 FR 71088 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-11-16

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... November 1, 2011, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and... Change The NASDAQ Stock Market LLC proposes to create a new Rule 7056 entitled ``NASDAQ Options Fee...

  17. 76 FR 44076 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-07-22

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend NASDAQ Stock Market Equities Trading Rules 4757 and 4758 and NASDAQ Options... NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed with the Securities and Exchange...

  18. 75 FR 6077 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-02-05

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... given that on January 29, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or the ``Exchange'') filed with... markets. Such assessments consider factors such as a destination's latency, fill rates, reliability, and...

  19. 75 FR 77022 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-12-10

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... is hereby given that on November 24, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange..., assesses fees for its real time market data. In general, a customer that receives a data feed directly from...

  20. 78 FR 31616 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-05-24

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of..., 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed with the Securities and... shall include: (1)-(14) No change. (15) ``Market Maker Peg Order'' is a limit order that, upon entry...

  1. 77 FR 1542 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-01-10

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Fees for Members Using the NASDAQ Market Center January 4, 2012. Pursuant to... is hereby given that on December 28, 2011, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

  2. 75 FR 57091 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-09-17

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Fees for Members Using the NASDAQ Market Center September 10, 2010. Pursuant...\\ notice is hereby given that on September 7, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

  3. 75 FR 77034 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-12-10

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of..., notice is hereby given that on December 3, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or ``Exchange...) Pricing Obligations. For NMS stocks (as defined in Rule 600 under Regulation NMS) a Market Maker shall...

  4. 78 FR 28912 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-05-16

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... is hereby given that on April 30, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange... ``Options Pricing,'' at Section 2 governing pricing for NASDAQ members using the NASDAQ Options Market...

  5. 75 FR 33878 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-06-15

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Modify Fees for Members Using the NASDAQ Market Center June 9, 2010. Pursuant to... is hereby given that on June 1, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the...

  6. 76 FR 35930 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-06-20

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt a Market Order Spread Protection Feature June 14, 2011. Pursuant to Section... hereby given that on June 8, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed...

  7. 78 FR 27466 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-05-10

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a..., 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and Exchange... for which the Exchange is the listing market, the System shall determine whether a transaction in a...

  8. 78 FR 49308 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-08-13

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on July 25, 2013 The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with... market data is transmitted by these new switches. The Exchange's proposal provides the co-located client...

  9. 78 FR 3480 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-01-16

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... is hereby given that on January 4, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange... historical latency of the member firm's order messages sent to and from the NASDAQ Market Center (``System...

  10. 76 FR 48189 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-08-08

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... given that on July 26, 2011, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the Securities and... Nasdaq for connectivity to systems operated by NASDAQ, including the Nasdaq Market Center, the FINRA...

  11. 76 FR 50521 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-08-15

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Regarding a Clerical Change to NASDAQ Options Market Rules August 9, 2011. Pursuant to... is hereby given that on August 2, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ...

  12. 77 FR 22042 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2012-04-12

    ... provide information regarding, for example, volume metrics, number of MQP Market Makers in target...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To Establish the Market Quality Program April 6, 2012. Pursuant to...

  13. 77 FR 48570 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2012-08-14

    ... Underlying Securities) of the NASDAQ Options Market rules.\\11\\ Additionally, the Target Component's and the...\\ Additionally, the Target Component's and the Benchmark Component's trading volume (in all markets in which the...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change Relating to the...

  14. 77 FR 15163 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-03-14

    ... troubling trend of reduced participation in the equity markets by individual investors, and that nearly 30... different asset classes within a single strategy. NASDAQ also notes that cash equities and options markets...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...

  15. 77 FR 21823 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-04-11

    ... Commission Chairman on what she viewed as a troubling trend of reduced participation in the equity markets by... investment strategy. NASDAQ also notes that cash equities and options markets are linked, with liquidity and...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...

  16. 75 FR 63238 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-10-14

    ... availability of the credit to only DLPs providing displayed liquidity through the Nasdaq Market Center. A... market in ETFs and ILSs. As currently written, however, Rule 7018(i) provides a credit for any type of...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...

  17. 78 FR 29193 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-05-17

    ... actively in the NASDAQ Market Center justifiably earn the higher credit of $0.0005 per share executed. This...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Remove Pilot Restrictions From NASDAQ's Qualified Market Maker and NBBO Setter...

  18. 77 FR 47472 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2012-08-08

    ... proposed rule change to make certain amendments that, in part, clarified the operation of the new Market... equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change, as Modified by...

  19. 77 FR 27256 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-05-09

    ... \\21\\ routing strategy but that execute in the Nasdaq Market Center. Accordingly, such orders will be...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... given that on April 25, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the...

  20. 78 FR 17272 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-03-20

    ... the locking or crossing market center. LIST is a routing strategy that is used by firms that wish for...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a... March 1, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the Securities and...

  1. 78 FR 49578 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-08-14

    ... market center. LIST is a routing strategy that is used by firms that wish for their orders to participate...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a... hereby given that on August 5, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with...

  2. Market power versus regulatory power in the Spanish electricity system, 1973-1996

    International Nuclear Information System (INIS)

    Garrues-Irurzun, Josean

    2010-01-01

    This study not only establishes that the institutional changes (the change of political regime) and economic changes (the energy crisis) that occurred during the 70s and 80s had an important effect on business strategies within the Spanish electricity sector, but, above all, it shows how the resulting regulatory model was not the product of any clearly defined plan on the part of the Spanish authorities (as the majority of authors seem to implicitly or explicitly maintain), but rather it arose from the dialectical interaction between companies which resisted losing the power of the market, and institutions which, in order to define any medium term energy policy in the future European domestic electricity market, required an increase in their regulatory power. (author)

  3. Localizing potentially active post-transcriptional regulations in the Ewing's sarcoma gene regulatory network

    Directory of Open Access Journals (Sweden)

    Delyon Bernard

    2010-11-01

    Full Text Available Abstract Background A wide range of techniques is now available for analyzing regulatory networks. Nonetheless, most of these techniques fail to interpret large-scale transcriptional data at the post-translational level. Results We address the question of using large-scale transcriptomic observation of a system perturbation to analyze a regulatory network which contained several types of interactions - transcriptional and post-translational. Our method consisted of post-processing the outputs of an open-source tool named BioQuali - an automatic constraint-based analysis mimicking biologist's local reasoning on a large scale. The post-processing relied on differences in the behavior of the transcriptional and post-translational levels in the network. As a case study, we analyzed a network representation of the genes and proteins controlled by an oncogene in the context of Ewing's sarcoma. The analysis allowed us to pinpoint active interactions specific to this cancer. We also identified the parts of the network which were incomplete and should be submitted for further investigation. Conclusions The proposed approach is effective for the qualitative analysis of cancer networks. It allows the integrative use of experimental data of various types in order to identify the specific information that should be considered a priority in the initial - and possibly very large - experimental dataset. Iteratively, new dataset can be introduced into the analysis to improve the network representation and make it more specific.

  4. Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues.

    Science.gov (United States)

    Sanders, M E; Huis in't Veld, J

    1999-01-01

    Properly formulated probiotic-containing foods offer consumers a low risk, low cost dietary component that has the potential to promote health in a variety of ways. Several such products are available commercially, although markets in Japan and Europe are more developed than in the USA. Once healthful attributes of a probiotic product have been identified, there remain microbiological, product, regulatory and labeling issues to be addressed prior to marketing. Microbiological and product issues include safety, effective scale-up for manufacturing, definition of probiotic activity, probiotic stability in the product over the course of product manufacture, shelf-life and consumption, definition of effective dose and target population(s), and development of quality assurance approaches. Examples of probiotic-containing foods are given. Regulatory and labeling issues are complicated because they differ for each country, but are likewise critical because they provide the means for communication of the product benefits to the consumer. The regulatory climate worldwide appears to be one of caution about overstating the benefits of such products but at the same time not preventing corporate commitment to marketing.

  5. Timing Is everything: quantifying regulatory and market readiness levels for technology transition policy analysis

    Energy Technology Data Exchange (ETDEWEB)

    Kobos, Peter Holmes [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Malczynski, Leonard A. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Walker, La Tonya Nicole [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Borns, David James [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States)

    2014-03-01

    People save for retirement throughout their career because it is virtually impossible to save all you’ll need in retirement the year before you retire. Similarly, without installing incremental amounts of clean fossil, renewable or transformative energy technologies throughout the coming decades, a radical and immediate change will be near impossible the year before a policy goal is set to be in place. This notion of steady installation growth over acute installations of technology to meet policy goals is the core topic of discussion for this research. This research operationalizes this notion by developing the theoretical underpinnings of regulatory and market acceptance delays by building upon the common Technology Readiness Level (TRL) framework and offers two new additions to the research community. The new and novel Regulatory Readiness Level (RRL) and Market Readiness Level (MRL) frameworks were developed. These components, collectively called the Technology, Regulatory and Market (TRM) readiness level framework allow one to build new constraints into existing Integrated Assessment Models (IAMs) to address research questions such as, ‘To meet our desired technical and policy goals, what are the factors that affect the rate we must install technology to achieve these goals in the coming decades?’

  6. Regulatory environment and its impact on the market value of investor-owned electric utilities

    Science.gov (United States)

    Vishwanathan, Raman

    While other regulated industries have one by one been exposed to competitive reform, electric power, for over eighty years, has remained a great monopoly. For all those years, the vertically integrated suppliers of electricity in the United States have been assigned exclusive territorial (consumer) franchises and have been closely regulated. This environment is in the process change because the electric power industry is currently undergoing some dramatic adjustments. Since 1992, a number of states have initiated regulatory reform and are moving to allow retail customers to choose their energy supplier. There has also been a considerable federal government role in encouraging competition in the generation and transmission of electricity. The objective of this research is to investigate the reaction of investors to the prevailing regulatory environment in the electric utility industry by analyzing the market-to-book value for investor-owned electric utilities in the United States as a gauge of investor concern or support for change. In this study, the variable of interest is the market valuation of utilities, as it captures investor confidence to changes in the regulatory environment. Initially a classic regression model is analyzed on the full sample (of the 96 investor-owned utilities for the years 1992 through 1996), providing a total number of 480 (96 firms over 5 years) observations. Later fixed- and random-effects models are analyzed for the same full-sample model specified in the previous analysis. Also, the analysis is carried forward to examine the impact of the size of the utility and its degree of reliability on nuclear power generation on market values. In the period of this study, 1992--1996, the financial security markets downgraded utilities that were still operating in a regulated environment or had a substantial percentage of their power generation from nuclear power plants. It was also found that the financial market was sensitive to the size of

  7. [Application of Markov model in post-marketing pharmacoeconomic evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Sun, Wentao; Xie, Yanming; Wang, Yongyan

    2011-10-01

    In post-marketing study of traditional Chinese medicine (TCM), pharmacoeconomic evaluation has an important applied significance. However, the economic literatures of TCM have been unable to fully and accurately reflect the unique overall outcomes of treatment with TCM. For the special nature of TCM itself, we recommend that Markov model could be introduced into post-marketing pharmacoeconomic evaluation of TCM, and also explore the feasibility of model application. Markov model can extrapolate the study time horizon, suit with effectiveness indicators of TCM, and provide measurable comprehensive outcome. In addition, Markov model can promote the development of TCM quality of life scale and the methodology of post-marketing pharmacoeconomic evaluation.

  8. [Thought on several problems of clinical revaluation of post-marketing herb research].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2010-06-01

    The revaluation of post-marketing herb is a complex research work, which concerns widely content and difficult to put it into practice. The starting of our country's revaluation post-marketing herb was comparatively late. It should profect it both in laws and regulations mechanism as well as technological specification. This article is try to focus on some attention problems in revaluation of postmarketing herb process. Such as the laws and regulations demand, the basement and the subject of revaluation of post-marketing herb.

  9. Bubbles, Post-Crash Dynamics, and the Housing Market

    OpenAIRE

    Crocker H. Liu; Adam Nowak; Stuart Rosenthal

    2014-01-01

    This paper documents and explains previously unrecognized post-crash dynamics following the collapse of a housing bubble. A simple model predicts that speculative developers ensure stable pre-crash relative prices between small and large homes while their post-crash exit allows small-home relative values to fall. Evidence from Phoenix supports the model. Although home prices doubled 2004-2006, relative prices of small-to-large homes remained nearly constant but then plummeted post-crash. As s...

  10. Regulatory assessment of brand changes in the commercial tobacco product market.

    Science.gov (United States)

    Wayne, G Ferris; Connolly, G N

    2009-08-01

    Regulatory oversight of tobacco product design has gained momentum in the US and internationally. Appropriate standards for assessing commercial brands and characterising product features must be considered a priority. An area of potential concern is in-market design changes adopted within a single commercial brand over time. Internal tobacco industry documents were identified and used to assess internal discussion of product guidelines and practices regarding in-market brand changes. Commercial tobacco products undergo a constant process of revision in-market, beginning at the most basic level of physical product characteristics and components, and including every aspect of design. These revisions commonly exceed guidelines for acceptable product variance adopted within the industry. While consumer and market testing is conducted to ensure that products remain acceptable to users, explicit marketing often may not accompany brand changes. In the absence of such marketing, it should not be assumed that a brand remains unchanged. For manufacturers, assessment of competitor brands includes identification and analysis of non-routine changes; that is, those changes likely to significantly alter the character of a given brand. Regulators must adopt a similar practice in determining standards for product evaluation in the face of ongoing commercial product revision.

  11. 75 FR 69502 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-11-12

    ... structure and assess a flat fee of $300 per test port, per month for all but CTCI and FIX connections to ACT...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of the Substance of the Proposed...

  12. 75 FR 63229 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-10-14

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on October 1, 2010, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed... has received approval to launch NASDAQ OMX PSX (``PSX'') \\3\\ as a new platform for trading NMS stocks...

  13. 76 FR 65306 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-10-20

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... hereby given that on October 6, 2011, the NASDAQ Stock Market, LLC (``NASDAQ'' or ``Exchange'') filed... experience a significant percentage price increase or decline. Once a stock is halted pursuant to the rule, a...

  14. 77 FR 68873 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of Longer...

    Science.gov (United States)

    2012-11-16

    ... ``Benchmark Orders'' Under NASDAQ Rule 4751(f) November 9, 2012. On May 1, 2012, The NASDAQ Stock Market LLC...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of Longer Period for Commission... proposed rule change to establish various ``Benchmark Orders'' under NASDAQ Rule 4751(f). The proposed rule...

  15. 77 FR 39314 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of a Longer...

    Science.gov (United States)

    2012-07-02

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Establish ``Benchmark Orders'' Under NASDAQ Rule 4751(f) June 26, 2012. On May 1, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange'') filed with the...

  16. 78 FR 62814 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2013-10-22

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Assume... Authority and Supervision September 30, 2013. On July 31, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or...) Manipulation patterns that monitor solely NASDAQ activity, including patterns that monitor the Exchange's...

  17. 78 FR 50123 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule...

    Science.gov (United States)

    2013-08-16

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule Change to Assume... NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed with the Securities and Exchange...: Manipulation patterns that monitor solely NASDAQ activity, including patterns that monitor the Exchange's...

  18. 77 FR 24549 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Amendment No. 1...

    Science.gov (United States)

    2012-04-24

    .... Further, to address concerns about the potential manipulation of lower priced stocks to meet the initial...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Amendment No. 1 and Order Granting..., 2012. I. Introduction On January 3, 2012, The NASDAQ Stock Market LLC (``Exchange'' or ``Nasdaq...

  19. 75 FR 9985 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2010-03-04

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change To Amend the... February 24, 2010, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ'') filed with the Securities... of the votes at any election of directors at which a quorum is present is duly elected to the Board...

  20. 76 FR 21085 - Self-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To...

    Science.gov (United States)

    2011-04-14

    ...-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To Amend The NASDAQ OMX Group, Inc. By- Laws April 8, 2011. I. Introduction On February 8, 2011, The NASDAQ Stock Market... vote cast either ``for'' or ``against'' that director's election. In its filing, NASDAQ noted that...

  1. 75 FR 60844 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Order Granting...

    Science.gov (United States)

    2010-10-01

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Order Granting Accelerated... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on September 14, 2010, The NASDAQ Stock Market... voting on the election of a member of the board of directors of an issuer (except for a vote with respect...

  2. 78 FR 75619 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2013-12-12

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change To Amend the...\\ notice is hereby given that on November 27, 2013, The NASDAQ Stock Market LLC (``Nasdaq'' or ``Exchange... to vote generally in the election of directors (the ``Voting Stock''), voting together as a single...

  3. 76 FR 77032 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-12-09

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify NASDAQ's Transaction Execution Fee and Credit Schedule in Rule 7018 December... 19b-4 thereunder,\\2\\ notice is hereby given that on November 30, 2011, The NASDAQ Stock Market LLC...

  4. 78 FR 36801 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-06-19

    ... market quality by allowing it to set or join the NBBO, the NBBO Setter Incentive credit would be paid...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of a... Credits June 13, 2013. Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act''),\\1...

  5. 76 FR 2732 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of Longer...

    Science.gov (United States)

    2011-01-14

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of Longer Period for Commission.... Introduction On June 18, 2010, The NASDAQ Stock Market LLC (``Nasdaq'' or the ``Exchange'') filed with the... change. The Commission may extend the period for issuing an order approving or disapproving the proposed...

  6. 76 FR 64142 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2011-10-17

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change Regarding... September 28, 2011, The NASDAQ Stock Market LLC (``NASDAQ'') filed with the Securities and Exchange... closely tailor their investment and risk management strategies and decisions. Furthermore, the Exchange...

  7. 77 FR 65237 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2012-10-25

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...Tree Trust October 19, 2012. I. Introduction On August 15, 2012, The NASDAQ Stock Market LLC (``Nasdaq... temporary defensive strategies that are inconsistent with its investment strategies, the Fund's ability to...

  8. 77 FR 49034 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

    Science.gov (United States)

    2012-08-15

    ... entering new orders at inferior prices. This occurs because the current process directs the order to NASDAQ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Amend Rule... June 14, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or ``Exchange''), filed with the Securities and...

  9. 76 FR 48193 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-08-08

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule To Amend Fees Assessed for Use of NASDAQ Pre-Trade Risk Management August 3, 2011. Pursuant...\\ notice is hereby given that, on July 25, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or ``NASDAQ...

  10. 76 FR 34281 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2011-06-13

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change To Adopt a Risk Monitor Mechanism June 7, 2011. Pursuant to Section 19(b)(1) of the Securities Exchange Act of... NASDAQ Stock Market LLC (``NASDAQ'') filed with the Securities and Exchange Commission (``Commission...

  11. 78 FR 70388 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-11-25

    ... [bracketed]. New text is italicized. NASDAQ Stock Market Rules Options Rules * * * * * Chapter VI Trading... the need for Market Makers to cancel and re-enter orders depending on time of opening. \\10\\ Chapter VI..., and the CSCO calls open on the Exchange. The Market Maker will now need to mark new bids as Post-Only...

  12. [Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

  13. Elucidating MicroRNA Regulatory Networks Using Transcriptional, Post-transcriptional, and Histone Modification Measurements

    Directory of Open Access Journals (Sweden)

    Sara J.C. Gosline

    2016-01-01

    Full Text Available MicroRNAs (miRNAs regulate diverse biological processes by repressing mRNAs, but their modest effects on direct targets, together with their participation in larger regulatory networks, make it challenging to delineate miRNA-mediated effects. Here, we describe an approach to characterizing miRNA-regulatory networks by systematically profiling transcriptional, post-transcriptional and epigenetic activity in a pair of isogenic murine fibroblast cell lines with and without Dicer expression. By RNA sequencing (RNA-seq and CLIP (crosslinking followed by immunoprecipitation sequencing (CLIP-seq, we found that most of the changes induced by global miRNA loss occur at the level of transcription. We then introduced a network modeling approach that integrated these data with epigenetic data to identify specific miRNA-regulated transcription factors that explain the impact of miRNA perturbation on gene expression. In total, we demonstrate that combining multiple genome-wide datasets spanning diverse regulatory modes enables accurate delineation of the downstream miRNA-regulated transcriptional network and establishes a model for studying similar networks in other systems.

  14. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

    Science.gov (United States)

    Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

    2018-05-02

    There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  15. State Electricity Regulatory Policy and Distributed Resources: Accommodating Distributed Resources in Wholesale Markets

    Energy Technology Data Exchange (ETDEWEB)

    Weston, F.; Harrington, C.; Moskovitz, D.; Shirley, W.; Cowart, R.; Sedano, R.

    2002-10-01

    Distributed resources can provide cost-effective reliability and energy services - in many cases, obviating the need for more expensive investments in wires and central station electricity generating facilities. Given the unique features of distributed resources, the challenge facing policymakers today is how to restructure wholesale markets for electricity and related services so as to reveal the full value that distributed resources can provide to the electric power system (utility grid). This report looks at the functions that distributed resources can perform and examines the barriers to them. It then identifies a series of policy and operational approaches to promoting DR in wholesale markets. This report is one in the State Electricity Regulatory Policy and Distributed Resources series developed under contract to NREL (see Annual Technical Status Report of the Regulatory Assistance Project: September 2000-September 2001, NREL/SR-560-32733). Other titles in this series are: (1) Distributed Resource Distribution Credit Pilot Programs - Revealing the Value to Consumers and Vendors, NREL/SR-560-32499; (2) Distributed Resources and Electric System Reliability, NREL/SR-560-32498; (3) Distribution System Cost Methodologies for Distributed Generation, NREL/SR-560-32500; (4) Distribution System Cost Methodologies for Distributed Generation Appendices, NREL/SR-560-32501

  16. Uranium and Nuclear Market, the horizon post-Fukushima

    International Nuclear Information System (INIS)

    Leboucher, Isabelle

    2014-01-01

    Changes in installed nuclear capacity since 2011: ► Shrinking installed fleet ◆ Fukushima linked decision • Germany: phase out planned for 2022; • Belgium: government set dates for reactor closures (2015-2025); • Japan: fleet shut down; nevertheless, safety reviews for restart; • Switzerland: new energy law draft, new build under question; • USA: 5 early shutdowns announcements in 2013-2014. ► Some new build projects postponed ◆ USA: challenging under current electricity market conditions ◆ Europe: electricity prices and financing conditions are challenging in some countries (Bulgaria, Czech Republic,…)

  17. [Exploration of how to formulate guidelines on post-marketing traditional Chinese medicine surveillance].

    Science.gov (United States)

    Zhang, Wen; Xie, Yan-Ming; Yu, Wen-Ya

    2013-09-01

    Combining the world health organization's (WHO), the United States and the European union's relevant laws and guidelines on post-marketing drug surveillance to judge the status of post-marketing surveillance of traditional Chinese medicine(TCM) in China. We found that due to the late start of post-marketing surveillance of traditional Chinese medicine, the appropriate guidelines are yet to be developed. Hence, hospitals, enterprises and research institutions do not have a shared foundation from which to compare their research results. Therefore there is an urgent need to formulate such post-marketing surveillance guidelines. This paper has used as guidance various technical documents such as, "procedures to formulate national standards" and "testing methods of management in formulating traditional Chinese medicine standards" and has combined these to produce a version of post-marketing surveillance particular to Chinese medicine in China. How to formulate these guidelines is discussed and procedures and methods to formulate technical specifications are introduced. These provide a reference for future technical specifications and will assist in the development of TCM.

  18. Common market but divergent regulatory practices: exploring European regulation and the effect on regulatory uncertainty in the marketing authorization of medical products

    NARCIS (Netherlands)

    Chowdhury, Nupur

    2013-01-01

    The medical product sector is characterised by a regulatory patchwork of European and national laws and guidelines operating concurrently with each other. Each of these sectors are characterised by different levels of regulatory uncertainty that may undermine the effectiveness of the regulatory

  19. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents

    Directory of Open Access Journals (Sweden)

    J.B. Calixto

    2000-02-01

    Full Text Available This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs. Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

  20. Post-crisis asymmetries of the world market development of banking services

    Directory of Open Access Journals (Sweden)

    Vladyslav Тіpanov

    2011-09-01

    Full Text Available In the article there were analyzed theoretical backgrounds for defining the concept «banking service» by scientists from different countries: considered its main characteristics and classification, determined the key peculiarities of the world market functioning of banking services and its structure, found out the present-day developments of the world market of banking services under conditions of post-crisis period.

  1. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    Science.gov (United States)

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  2. A theory of planning horizons (1: market design in a post-neoclassical world

    Directory of Open Access Journals (Sweden)

    Frederic B. Jennings, Jr.

    2012-05-01

    Full Text Available The neoclassical case supporting competitive frames and market solutions has failed to promote stable world-wide economic development. Other approaches in economics incorporate social culture, increasing returns, market power, ecological limits and complementarity, yielding broader applications for development theory. In this paper a theory of planning horizons is introduced to raise some meaningful questions about the traditional view with respect to its substitution, decreasing returns and independence assumptions. Suppositions of complementarity, increasing returns and interdependence suggest that competition is inefficient by upholding a myopic culture resistant to learning. Growth – though long believed to rise from markets and competitive values – may not derive from these sources. Instead, as civilizations advance, shifting from material wants to higher-order intangible output, they evolve from market tradeoffs (substitution and scarcity into realms of common need (complementarity and abundance. The policy implications of horizonal theory are explored, with respect to regulatory aims and economic concerns. Such an approach emphasizes strict constraints against entry barriers, ecological harm, market power abuse and ethical lapses. Social cohesion – not competition – is sought as a means to extend horizons and thereby increase efficiency, equity and ecological health. The overriding importance of horizon effects for regulatory assessment dominates other orthodox standards in economics and law. Reframing economics along horizonal lines suggests some meaningful insight on the proper design of economic systems.

  3. Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications.

    Science.gov (United States)

    Liberti, Lawrence; Stolk, Pieter; McAuslane, James Neil; Schellens, Jan; Breckenridge, Alasdair M; Leufkens, Hubert

    2015-06-01

    Guidance and exploratory evidence indicate that the type of endpoints and the magnitude of their outcome can define a therapy's clinical activity; however, little empirical evidence relates specific endpoint properties with regulatory outcomes. We explored the relationship of 3 endpoint properties to regulatory outcomes by assessing 50 oncology marketing authorization applications (MAAs; reviewed from 2009 to 2013). Overall, 16 (32%) had a negative outcome. The most commonly used hard endpoints were overall survival (OS) and the duration of response or stable disease. OS was a component of 91% approved and 63% failed MAAs. The most commonly used surrogate endpoints were progression-free survival (PFS), response rate, and health-related quality of life assessments. There was no difference (p = .3801) between the approved and failed MAA cohorts in the proportion of hard endpoints used. A mean of slightly more than four surrogate endpoints were used per approved MAA compared with slightly more than two for failed MAAs. Longer OS and PFS duration outcomes were generally associated with approvals, often when not statistically significant. The approved cohort was associated with a preponderance of statistically significant (p < .05) improvements in primary endpoints (p < .0001 difference between the approved and failed groups). Three key endpoint properties (type of endpoint [hard/surrogate], magnitude of an endpoint outcome, and its statistical significance) are consistent with the European Medicines Agency guidance and, notwithstanding the contribution of unique disease-specific circumstances, are associated with a predictable positive outcome for oncology MAAs. Regulatory decisions made by the European Medicines Agency determine which new medicines will be available to European prescribers and for which therapeutic indications. Regulatory success or failure can be influenced by many factors. This study assessed three key properties of endpoints used in

  4. Bringing plant-based veterinary vaccines to market: Managing regulatory and commercial hurdles.

    Science.gov (United States)

    MacDonald, Jacqueline; Doshi, Ketan; Dussault, Marike; Hall, J Christopher; Holbrook, Larry; Jones, Ginny; Kaldis, Angelo; Klima, Cassidy L; Macdonald, Phil; McAllister, Tim; McLean, Michael D; Potter, Andrew; Richman, Alex; Shearer, Heather; Yarosh, Oksana; Yoo, Han Sang; Topp, Edward; Menassa, Rima

    2015-12-01

    The production of recombinant vaccines in plants may help to reduce the burden of veterinary diseases, which cause major economic losses and in some cases can affect human health. While there is abundant research in this area, a knowledge gap exists between the ability to create and evaluate plant-based products in the laboratory, and the ability to take these products on a path to commercialization. The current report, arising from a workshop sponsored by an Organisation for Economic Co-operation and Development (OECD) Co-operative Research Programme, addresses this gap by providing guidance in planning for the commercialization of plant-made vaccines for animal use. It includes relevant information on developing business plans, assessing market opportunities, manufacturing scale-up, financing, protecting and using intellectual property, and regulatory approval with a focus on Canadian regulations. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

  5. The climate impacts of bioenergy systems depend on market and regulatory policy contexts.

    Science.gov (United States)

    Lemoine, Derek M; Plevin, Richard J; Cohn, Avery S; Jones, Andrew D; Brandt, Adam R; Vergara, Sintana E; Kammen, Daniel M

    2010-10-01

    Biomass can help reduce greenhouse gas (GHG) emissions by displacing petroleum in the transportation sector, by displacing fossil-based electricity, and by sequestering atmospheric carbon. Which use mitigates the most emissions depends on market and regulatory contexts outside the scope of attributional life cycle assessments. We show that bioelectricity's advantage over liquid biofuels depends on the GHG intensity of the electricity displaced. Bioelectricity that displaces coal-fired electricity could reduce GHG emissions, but bioelectricity that displaces wind electricity could increase GHG emissions. The electricity displaced depends upon existing infrastructure and policies affecting the electric grid. These findings demonstrate how model assumptions about whether the vehicle fleet and bioenergy use are fixed or free parameters constrain the policy questions an analysis can inform. Our bioenergy life cycle assessment can inform questions about a bioenergy mandate's optimal allocation between liquid fuels and electricity generation, but questions about the optimal level of bioenergy use require analyses with different assumptions about fixed and free parameters.

  6. Revisiting Stock Market Integration Pre-Post Subprime Mortgage Crisis: Insight From BRIC Countries

    Directory of Open Access Journals (Sweden)

    Chin-Hong Puah

    2015-07-01

    Full Text Available This study revisits the long-run relationships and short-run dynamic causal linkages among BRIC stock market, with the particular attention to the 2008 subprime mortgage crisis. Extending related empirical studies, comparative analyses of pre-crisis, and post-crisis periods were conducted to comprehensively evaluate how stock market integration was affected by financial crises. In general, after employing cointegration test and VAR test, the results reveal the increase of stock market integration in BRICs after the subprime crisis. The evidence also found that China stock market is the most influential among the BRICs, in which China stock market has the ability to Granger cause the other three BRICs member countries. An important implication of our findings is that the degree of integration among countries tends to change over time, especially around periods marked by financial crises.

  7. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

    Science.gov (United States)

    Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

    2015-01-01

    With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

  8. Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

    Science.gov (United States)

    Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

    2010-01-01

    The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

  9. Labour Market Structure in Malaysia: Pre- and Post-Market Gender Comparison

    OpenAIRE

    Chung-Khain Wye; Rahmah Ismail

    2012-01-01

    Gender inequality in Malaysian labour market can be observed through labour force participation, unemployment, occupational distribution, top management employment involving decision making, and average monthly salary. Such an inequality generally works to the disadvantage of females, notwithstanding their outperformance of educational attainment over their males’ counterparts. Case study in the ICT services subsector points to the importance of imparting employability skills among females to...

  10. 77 FR 8936 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-02-15

    ... defined as ``the ratio of (A) the total number of liquidity-providing orders entered by a member through... trading sessions. (3) The ratio between shares of liquidity provided through the MPID and total shares..., or pre-market and/or post- market hours; and to maintain a high ratio of liquidity provision to order...

  11. Arthritis, Rheumatism and Aging Medical Information System Post-Marketing Surveillance Program.

    Science.gov (United States)

    Singh, G

    2001-05-01

    The Arthritis, Rheumatism, and Aging Post-Marketing Surveillance Program (ARAMIS-PMS) is a collection of multicenter, prospective, noninterventional, observational longitudinal studies of patients with rheumatic diseases. The ARAMIS-PMS program aims to study patients in normal clinical setting to evaluate the real-life effectiveness, toxicity, and cost effectiveness of various medications used to treat rheumatic diseases.

  12. [Post-marketing drug safety-risk management plan(RMP)].

    Science.gov (United States)

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  13. [Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Fu, Yingkun; Xie, Yanming

    2011-10-01

    In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

  14. 76 FR 45308 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2011-07-28

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change To... change should provide NOM Participants assistance in effectively managing their quotations. \\6\\ 15 U.S.C...,\\2\\ a proposed rule change to adopt a new risk monitor mechanism. The proposed rule change was...

  15. 78 FR 52994 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-08-27

    ... believes that the change will provide members with an additional tool for managing the book of [[Page 52995... Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...

  16. 76 FR 64403 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-10-18

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65381; File No. SR-NASDAQ-2011-128] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Customer Rebates To Add Liquidity September 22, 2011. Correction In notice...

  17. 78 FR 62834 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed...

    Science.gov (United States)

    2013-10-22

    ... Fund of First Trust Exchange-Traded Fund VII October 9, 2013. I. Introduction On August 16, 2013, The... for the provision of custody, transfer agency, and accounting agent services with the same or with...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change...

  18. 76 FR 19819 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-04-08

    ... each consolidated last-sale price disseminated by a network processor over a five minute rolling period...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Pilot Period of the Trading Pause for Individual Stocks Contained in the...

  19. 75 FR 78302 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-12-15

    ... last-sale price disseminated by a network processor over a five-minute rolling period measured...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Pilot Period of the Trading Pause for Individual Stocks Contained in the...

  20. What do implementers need in terms of regulatory safety criteria for the post-closure phase?

    International Nuclear Information System (INIS)

    Cahen, B.

    2010-01-01

    Bruno Cahen, Director Safety Division (ANDRA) presented the point of view of the NEA Integration Group for the Safety Case (IGSC) on 'What do implementers need in terms of regulatory safety criteria for the post-closure phase?' B. Cahen acknowledged that the national experience in siting and developing conceptual designs of geological disposal is growing rapidly. It implies increasing opportunities for interactions between implementers and regulators. There has been large development of international guidance in the recent years. Many regulators have already developed a regulatory framework. The implementers need practical, transparent and deliverable regulations. These regulations should draw on experiences gained from development of geological disposal projects. The IGSC has identified five key questions that the RF may focus on: 1. Over what time frame are the waste deemed to present a hazard? 2. Over what time frames are regulatory criteria applied and do they change over time? 3. Over what time frame(s) are safety assessments required to be conducted? 4. How do implementers have to address uncertainties in the long time frames? 5. What happens after cut-offs: are additional analyses needed? What types of arguments are to be used? Stable, understandable and practical criteria mean, namely, that they need to be developed on a strong scientific and societal basis, that there is consistency of safety options and requirements for different types of waste, that, in the longer time frames, the emphasis is given to robust systems, passive safety and multiple safety functions and that the criteria should fit the various phases of the project (siting, designing, operating, closure and post-closure). Experience feedback from safety cases shows that safety priorities depend very much on time frames. The derived safety criteria for the individual components should lead to measurable, verifiable specifications. The assessment of geological repository post-closure safety

  1. Do societal values influence financial development? : New evidence on the effects of post materialism and institutions on stock markets

    NARCIS (Netherlands)

    Jordaan, J.A.; Dima, Dogdan; Goleț, Ionuț

    2016-01-01

    In this paper we present new evidence on the effects of social values on stock market development. Using panel data for a heterogeneous set of 43 countries, we use the Inglehart post materialism index to identify the relation between the degree of post materialism and the size of stock markets.

  2. [Strategy of constructing post-market integral evaluation system of traditional Chinese medicine injection].

    Science.gov (United States)

    Zhang, Xiao-Yu; Wang, Yan-Ping; Lin, Li-Kai; Shang, Hong-Cai; Wang, Yong-Yan

    2017-08-01

    As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels: optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects: mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation. Copyright© by the Chinese Pharmaceutical Association.

  3. Herpes zoster vaccine live: A 10 year review of post-marketing safety experience.

    Science.gov (United States)

    Willis, English D; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W; Halsey, Neal A; Gershon, Anne A

    2017-12-19

    Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Comparison of Group-Buying Online Auction and Posted Pricing Mechanism in an Uncertain Market

    Institute of Scientific and Technical Information of China (English)

    CHEN Jian; LIU Yunhui; SONG Xiping

    2004-01-01

    Demand uncertainty is a key factor for the seller's decision making, especially in the e-business environment, for the website to sell products through the online auction. In this paper, two kinds of demand uncertainties are considered: the consumer regime uncertainty and the inherent randomness of the market environment. Then, how to use a novel business model and group-buying auction (GBA) is analyzed in such a market environment. Based on the comparison of the GBA and the posted price mechanism, some conditions that favor the GBA are provided.

  5. The Price and Volatility Dynamics in the Swedish-Norwegian Renewable Electricity Certificate MarketA Study of Spillover Effects and Regulatory changes

    OpenAIRE

    Finell, Philip; Hiller, Maria

    2016-01-01

    The market for renewable electricity certificates (REC) is the primary support system for renewable energy in Sweden and Norway. Regulatory uncertainty and equity markets have previously been proven to impact the volatility of the REC spot contract. As policy makers, renewable electricity investors and other stakeholders aim for profitability and efficient regulation, additional insights of the dynamics in the  REC market is needed. This study examines regulatory uncertainty on both REC spot ...

  6. Direct broadcast satellite-radio market, legal, regulatory, and business considerations

    Science.gov (United States)

    Sood, Des R.

    1991-03-01

    A Direct Broadcast Satellite-Radio (DBS-R) System offers the prospect of delivering high quality audio broadcasts to large audiences at costs lower than or comparable to those incurred using the current means of broadcasting. The maturation of mobile communications technologies, and advances in microelectronics and digital signal processing now make it possible to bring this technology to the marketplace. Heightened consumer interest in improved audio quality coupled with the technological and economic feasibility of meeting this demand via DBS-R make it opportune to start planning for implementation of DBS-R Systems. NASA-Lewis and the Voice of America as part of their on-going efforts to improve the quality of international audio broadcasts, have undertaken a number of tasks to more clearly define the technical, marketing, organizational, legal, and regulatory issues underlying implementation of DBS-R Systems. The results and an assessment is presented of the business considerations underlying the construction, launch, and operation of DBS-R Systems.

  7. Direct broadcast satellite-radio market, legal, regulatory, and business considerations

    Science.gov (United States)

    Sood, Des R.

    1991-01-01

    A Direct Broadcast Satellite-Radio (DBS-R) System offers the prospect of delivering high quality audio broadcasts to large audiences at costs lower than or comparable to those incurred using the current means of broadcasting. The maturation of mobile communications technologies, and advances in microelectronics and digital signal processing now make it possible to bring this technology to the marketplace. Heightened consumer interest in improved audio quality coupled with the technological and economic feasibility of meeting this demand via DBS-R make it opportune to start planning for implementation of DBS-R Systems. NASA-Lewis and the Voice of America as part of their on-going efforts to improve the quality of international audio broadcasts, have undertaken a number of tasks to more clearly define the technical, marketing, organizational, legal, and regulatory issues underlying implementation of DBS-R Systems. The results and an assessment is presented of the business considerations underlying the construction, launch, and operation of DBS-R Systems.

  8. The Impact of Active Labour Market Policy on Post-Unemployment Outcomes

    DEFF Research Database (Denmark)

    Blasco, Sylvie; Rosholm, Michael

    While job search theory predicts that active labour market policies (ALMPs) can affect post-unemployment outcomes, empirical evaluations investigating transition rates have mostly focused on the impact of ALMPs on exit rates from the current unemployment spell. We use a social experiment, which w......, the positive impact of the treatment becomes smaller but remains significant. 80% of the global impact of intensification acts through the direct channel for men.......While job search theory predicts that active labour market policies (ALMPs) can affect post-unemployment outcomes, empirical evaluations investigating transition rates have mostly focused on the impact of ALMPs on exit rates from the current unemployment spell. We use a social experiment, which...... was conducted in Denmark in 2005-6, to investigate the effects of a dramatic intensification of ALMPs on reemployment stability. We investigate the nature of this impact. We estimate a duration model with lagged duration dependence to separately identify "indirect" (via shorter unemployment duration...

  9. How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

    Directory of Open Access Journals (Sweden)

    Ran Tian

    2017-10-01

    Full Text Available The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern. The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine. In this paper, we propose a reappraisal protocol called “precise proprietary Chinese medicine” to precisely i define the therapeutic aim; ii design the protocol; iii control the quality of proprietary Chinese medicine; iv implement the protocol in the trial; v study the mechanism-of-action of the proprietary Chinese medicine and vi describe the indications of the proprietary Chinese medicine. We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.

  10. [Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

    2014-09-01

    Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

  11. [Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

    Science.gov (United States)

    Liu, Huan; Xie, Yanming

    2011-10-01

    The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

  12. Estimating post-marketing exposure to pharmaceutical products using ex-factory distribution data.

    Science.gov (United States)

    Telfair, Tamara; Mohan, Aparna K; Shahani, Shalini; Klincewicz, Stephen; Atsma, Willem Jan; Thomas, Adrian; Fife, Daniel

    2006-10-01

    The pharmaceutical industry has an obligation to identify adverse reactions to drug products during all phases of drug development, including the post-marketing period. Estimates of population exposure to pharmaceutical products are important to the post-marketing surveillance of drugs, and provide a context for assessing the various risks and benefits, including drug safety, associated with drug treatment. This paper describes a systematic approach to estimating post-marketing drug exposure using ex-factory shipment data to estimate the quantity of medication available, and dosage information (stratified by indication or other factors as appropriate) to convert the quantity of medication to person time of exposure. Unlike the non-standardized methods often used to estimate exposure, this approach provides estimates whose calculations are explicit, documented, and consistent across products and over time. The methods can readily be carried out by an individual or small group specializing in this function, and lend themselves to automation. The present estimation approach is practical and relatively uncomplicated to implement. We believe it is a useful innovation. Copyright 2006 John Wiley & Sons, Ltd.

  13. Emissions to the Atmosphere from Amine-Based Post Combustion CO2 Capture Plant - Regulatory Aspects

    International Nuclear Information System (INIS)

    Azzi, Merched; Angove, Dennys; Dave, Narendra; Day, Stuart; Do, Thong; Feron, Paul; Sharma, Sunil; Attalla, Moetaz; Abu Zahra, Mohammad

    2014-01-01

    Amine-based Post Combustion Capture (PCC) of CO 2 is a readily available technology that can be deployed to reduce CO 2 emissions from coal fired power plants. However, PCC plants will likely release small quantities of amine and amine degradation products to the atmosphere along with the treated flue gas. The possible environmental effects of these emissions have been examined through different studies carried out around the world. Based on flue gas from a 400 MW ultra-supercritical coal fired power plant Aspen-Plus PCC process simulations were used to predict the potential atmospheric emissions from the plant. Different research initiatives carried out in this area have produced new knowledge that has significantly reduced the risk perception for the release of amine and amine degradation products to the atmosphere. In addition to the reduction of the CO 2 emissions, the PCC technology will also help in reducing SO x and NO 2 emissions. However, some other pollutants such as NH 3 and aerosols will increase if appropriate control technologies are not adopted. To study the atmospheric photo-oxidation of amines, attempts are being made to develop chemical reaction schemes that can be used for air quality assessment. However, more research is still required in this area to estimate the reactivity of amino solvents in the presence of other pollutants such as NO x and other volatile organic compounds in the background air. Current air quality guidelines may need to be updated to include limits for the additional pollutants such as NH 3 , nitrosamines and nitramines once more information related to their emissions is available. This paper focuses on describing the predicted concentrations of major pollutants that are expected to be released from a coal fired power plant obtained by ASPEN-Plus PCC process simulations in terms of current air quality regulations and other regulatory aspects. (authors)

  14. Understanding banking regulatory and market framework in South Africa including the perceived strength, weaknesses, opportunities and threats

    Directory of Open Access Journals (Sweden)

    Tankiso Moloi

    2014-08-01

    Full Text Available Following the global financial crisis of 2007, the manner in which banks conduct their business became the subject of interest to authorities. In South Africa, most analysts argued that the financial system was insulated by the prudent regulatory system. This paper reviewed the banking regulation and market framework applicable in the South African context. In reviewing regulation and banking market framework, it was found that the principal legal instrument which seeks to achieve credibility, stability and economic growth, is the Banks Act, No. 94 of 1990 (the Banks Act. Considering the applicable regulation, the paper concluded that South Africa has a developed and well regulated banking system which compares favourably with regulatory environment applied by the developed countries. It was, however; cautioned that further regulation such as the recently announced ‘Twin Peaks’ approach to financial regulation could result in unintended consequences, such as driving a larger share of activity into the shadow banking sector.

  15. Post-Marketing Regulation of Medicines Withdrawn from the Market Because of Drug-Attributed Deaths: An Analysis of Justification.

    Science.gov (United States)

    Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

    2017-05-01

    Several medicinal products have been withdrawn from the market because of drug-attributed deaths. However, there has been no investigation of whether such withdrawals were justified, and the extent to which confirmatory studies are used to investigate drug-adverse event relationships when deaths are reported is uncertain. We documented medicinal products withdrawn from the market because of drug-attributed deaths, identified confirmatory studies investigating the drug-adverse event relationships, examined whether withdrawals of medicinal products because of drug-attributed deaths after marketing were justified based on a mechanistic analysis, and examined the trends over time. We searched electronic and non-electronic sources to identify medicinal products that were withdrawn because of drug-attributed deaths. We used a previously published algorithm to examine whether the withdrawals of products were justified. We then searched PubMed and Google Scholar to identify studies investigating the drug-adverse event relationships, used the Oxford Centre for Evidence-Based Medicine criteria to document the levels of evidence, and assessed whether the evidence of an association was confirmed. We included 83 medicinal products. The reasons for withdrawal appeared to have been justified in 80 cases (96%). The median interval between the first reported adverse reaction that was related to the cause of death and the first reported death was 1 year (interquartile range = 1-3); products were withdrawn sooner when the interval between the first reported relevant adverse reaction and the first death was shorter. Confirmatory studies were conducted in 57 instances (69%), and there was evidence of an association in 52 cases (63%). Four products (5%) were re-introduced after initial withdrawal. Regulatory authorities have been justified in making withdrawal decisions when deaths have been attributed to medicinal products, using the precautionary principle when alternative decisions

  16. Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review.

    Science.gov (United States)

    Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

    2018-01-01

    Many analgesics have been withdrawn from the market because of adverse drug reactions. Controversy still surrounds the use of some approved analgesics for pain management. However, the trends and reasons for withdrawal of analgesics when harms are attributed to their use have not been systematically assessed. Areas covered: We conducted searches in PubMed; Embase; Google Scholar; clinicaltrials.gov; WHO databases of withdrawn products; websites of the European Medicines Agency, the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency; Meyler's Side Effects of Drugs; Stephens' Detection of New Adverse Drug Reactions; the Pharmaceutical Manufacturing Encyclopedia; and the Merck Index. We included licensed analgesics that were withdrawn after marketing because of adverse reactions between 1950 and March 2017. We excluded herbal products, non-human medicines, and non-prescription medicines. We used the Oxford Centre for Evidence Based Medicine criteria to document the levels of evidence, and chi-squared tests to compare withdrawal patterns across geographical regions. Expert opinion: Pharmacovigilance systems in low-resource settings should be strengthened. Greater co-ordination across regulatory authorities in assessing and interpreting the benefit-harm balance of new analgesics should be encouraged. Future reporting of harms in clinical trials of analgesics should follow standardized guidelines.

  17. Decoupling the Oil and Gas Prices. Natural Gas Pricing in the Post-Financial Crisis Market

    International Nuclear Information System (INIS)

    Kanai, Miharu

    2011-01-01

    This paper looks into natural gas pricing in the post-financial crisis market and, in particular, examines the question whether the oil-linked gas pricing system has outlived its utility as global gas markets mature and converge more rapidly than expected and as large new resources of unconventional gas shift the gas terms-of-trade. Two opposing natural gas pricing systems have coexisted for the last two decades. On the one hand, there is traditional oil-linked pricing, used in pipeline gas imports by Continental European countries and in LNG imports by the countries in Far East. The other is the system led by futures exchanges in deregulated, competitive markets largely in the UK and the US. World gas markets are changing and the basis and mechanisms of price formation are changing with them. There is no reason to expect a revolution in gas pricing, but formulas designed to address the challenges of the 1970's will need to adjust to the realities of the present and expectations for the 21. century. Because such changes will imply a redistribution of costs and benefits, vested shareholders will defend the status quo. But hopefully and ultimately, appropriately regulated markets will assert themselves and shareholders along the entire value chain will have their interests served

  18. Quality of alcohol-based hand disinfectants and their regulatory status. Development and marketing authorisation.

    Science.gov (United States)

    Stengele, Michael

    2008-10-01

    A 2005 survey showed that there are at least four legal product classifications for hand disinfectants in the European Union: medicinal products, biocidal products, cosmetics and medical devices. An internationally harmonized classification does not exist. The regulatory status of those products is defined at national level. In order to assure compliance with the regulations these four classifications provide different levels of official surveillance varying from product-specific marketing authorisations and production site audits to the obligation to just work in accordance with certain general guidelines. Biocidal product regulations cover eco-toxicological and toxicological aspects, but do not very much address to the customers' quality and efficacy expectations. In contrast, the medicinal product legislation is the most ambitious one claiming quality, safety, efficacy, and an independent benefit risk-assessment by an authority. In respect of ambition, the two remaining product categories--cosmetics and medical devices--rank between the both classifications mentioned above. For medical devices, it is the responsibility of the manufacturer to make sure the products meet defined essential requirements regarding quality, safety and performance and to have an appropriate quality assurance system implemented under third party control. For cosmetics there are some legal restrictions, but within these it is the sole responsibility of the manufacturer to ensure that the products are safe and fulfil their claims. This paper describes one way out of this increasingly complex situation, the definition of a single quality standard meeting the users' expectations as well as all legal requirements regardless of the specific sales country. This international quality standard for products would take priority over any individual national standard, to the benefit of users.

  19. 76 FR 2178 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-01-12

    ... to provide non-displayed liquidity to offer an alternative to trading venues that are entirely dark... impact of the price changes upon the net fees paid by a particular market participant will depend upon a... method. The Commission will post all comments on the Commission's Internet Web site ( http://www.sec.gov...

  20. Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

    Science.gov (United States)

    Silva, Ivair R

    2018-01-15

    Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

  1. Papers of a Canadian Institute conference : Western electricity markets forum : Are you prepared for regulatory restructuring and standard market design?

    International Nuclear Information System (INIS)

    2003-01-01

    This forum on western electricity markets presented the latest information concerning several challenges facing the electricity markets of both Western Canada and the United States. Corporate leaders and industry regulators addressed a number of issues. Among them, the California Independent System Operator presented its views on the Standard Market Design initiative which has the potential to alter the dynamics of power markets in Canada and the United States. The creation of a new International Organization for Standardization (ISO) structure for Alberta's deregulated power markets was discussed by both the Power Pool of Alberta and the Alberta Department of Energy. The outlook for electricity price volatility in the west was examined in a presentation by BP Energy Canada. The prospect for transmission links between Alberta and other western states and provinces was the topic of presentations made by ATCO Electric and AltaLink. The future of the power generation in Alberta was discussed by TransAlta, EPCOR, and ENMAX. In addition, there were two case studies presented from the California Energy Commission and the Independent Electricity Market Operator (IMO) of Ontario concerning the progress made to date on electricity deregulation. A look at lessons to be learned from other jurisdictions was also included. A total of sixteen presentations were made at this forum, of which five have been indexed separately for inclusion in this database. refs., tabs., figs

  2. Risk Management Post-Marketing Surveillance for the Abuse of Medications Acting on the Central Nervous System: Expert Panel Report

    Science.gov (United States)

    Johanson, Chris-Ellyn; Balster, Robert L.; Henningfield, Jack E.; Schuster, Charles R.; Anthony, James C.; Barthwell, Andrea G.; Coleman, John J.; Dart, Richard C.; Gorodetzky, Charles W.; O’Keeffe, Charles; Sellers, Edward M.; Vocci, Frank; Walsh, Sharon L.

    2010-01-01

    The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October, 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and eleven recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized. PMID:19783383

  3. [Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments)].

    Science.gov (United States)

    Xie, Yan-Ming; Zhao, Yu-Bin; Jiang, Jun-Jie; Chang, Yan-Peng; Zhang, Wen; Shen, Hao; Lu, Peng-Fei

    2013-09-01

    Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

  4. The influence of regulatory fit and interactivity on brand satisfaction and trust in E-health marketing inside 3D virtual worlds (Second Life).

    Science.gov (United States)

    Jin, Seung-A Annie; Lee, Kwan Min

    2010-12-01

    Interactive three-dimensional (3D) virtual environments like Second Life have great potential as venues for effective e-health marketing and e-brand management. Drawing from regulatory focus and interactivity literatures, this study examined the effects of the regulatory fit that consumers experience in interactive e-health marketing on their brand satisfaction and brand trust. The results of a two-group comparison experiment conducted within Second Life revealed that consumers in the regulatory fit condition show greater brand satisfaction and brand trust than those in the regulatory misfit condition, thus confirming the persuasive influence of regulatory fit in e-brand management inside 3D virtual worlds. In addition, a structural equation modeling analysis demonstrated the mediating role of consumers' perceived interactivity in explaining the processional link between regulatory fit and brand evaluation. Theoretical contributions and managerial implications of these findings are discussed.

  5. Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review.

    Science.gov (United States)

    Polisena, Julie; Forster, Alan J; Cimon, Karen; Rabb, Danielle

    2013-10-10

    Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature. This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting. Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.

  6. Searching for New Regulatory Frameworks for the Intermediate Financial Structure in Post-Crisis Asia

    OpenAIRE

    Sayuri Shirai

    2001-01-01

    Intermediate Financial Structure 1. In a number of Asian countries, commercial banks are already playing an important role in the corporate bond market as issuers, underwriters, investors, and guarantors. This reflects banks’ already dominant financial positions in their financial markets, good reputation, and informational advantages. Thus, the role of banks for fostering the development of the corporate bond market and their complementary roles should be encouraged. 2. This financial landsc...

  7. 76 FR 77883 - Self-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-12-14

    ... funding of an SRO's regulatory operations in the Concept Release Concerning Self-Regulation \\18\\ and the release on the Fair Administration and Governance of Self- Regulatory Organizations.\\19\\ In the Concept... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65913; File No. SR-NASDAQ-2011-163] Self...

  8. A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

    Science.gov (United States)

    Velentgas, Priscilla; Bohn, Rhonda L; Brown, Jeffrey S; Chan, K Arnold; Gladowski, Patricia; Holick, Crystal N; Kramer, Judith M; Nakasato, Cynthia; Spettell, Claire M; Walker, Alexander M; Zhang, Fang; Platt, Richard

    2008-12-01

    We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system. Copyright (c) 2008 John Wiley & Sons, Ltd.

  9. 75 FR 64384 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Instituting Proceedings To...

    Science.gov (United States)

    2010-10-19

    ..., particularly in times of market stress, and exacerbate market volatility.\\8\\ \\7\\ See BATS Letter at 2; Deutsche... breakers. \\10\\ Id. \\11\\ Id. at 3-4. In its response, Nasdaq rejected the argument that the proposed... of individual exchange volatility moderators in times of market stress. In addition, as noted above...

  10. Impact of Insurance Market on Economic Growth in Post-Transition Countries

    Directory of Open Access Journals (Sweden)

    Phutkaradze Jaba

    2014-12-01

    Full Text Available The purpose of this work is to identify whether the development of an insurance market is linked to economic growth in former transition countries. A multiple regression analysis is employed to estimate the insurance-growth relationship, using a cross-country panel dataset analysis tracking annual total insurance penetration in 10 countries over the 2000-2012 period, and applying a fixed effect model to test the hypothesis that this linkage is demonstrably positive. The results show a negative and statistically non-significant correlation between insurance and GDP growth, suggesting a lack of evidence that insurance promotes economic growth in post-transition economies.

  11. Rethinking capital markets reform: a reassessment of Olson problem and regulatory dualism in the German capital markets from a varieties of capitalism perspective

    Directory of Open Access Journals (Sweden)

    André Ziccardi de Carvalho

    2015-09-01

    Full Text Available Since its proposition by Peter A. Hall and David Soskice the Varieties of Capitalism (VoC approach has been particularly important to explain the relationship between economic agents and sets of institutional arrangements that, even in regulatory scenarios that Law and Finance’s school would consider “less than optimal”, are able to generate sustainable economic growth. In this context the VoC approach has been consistently challenging the traditional “one fits all” approach towards capital markets reform usually endorsed by institutions such as the World Bank and the International Monetary Fund, as well as by many scholars and capital markets regulators associated with La Porta’s Law and Finance School. As any theoretical framework, however, the VoC approach also faces its own challenges and still lacks the scientific maturity achieved by the Law and Finance School. Consequently a conciliation between the relational view of the firm proposed by the VoC approach and the overview of corporate governance practices throughout the world presented by the Law and Finance School would be instrumental to construe a more clear understanding of the competitive advantages generated by certain sets of institutions and, at the same time, more accurately assess impacts of reforms that, even if implemented with the legitimate goal of promoting firms’ transparency and higher corporate governance standards, may counter-intuitively generate unprecedented corporate and capital markets crisis. By analyzing two concepts proposed by Ronald J. Gilson, Henry Hansmann and Mariana Pargendler that have an apparent fundamental link to La Porta’s school of Law and Finance (i.e. Olson Problem and Regulatory Dualism through a varieties of capitalism approach, this study aims at rethinking the traditional “one fits all” approach towards capital markets reform and taking a further step in the direction of conciliating the VoC approach with La Porta’s Law

  12. A decision support tool for the analysis of pricing, investment and regulatory processes in a decentralized electricity market

    International Nuclear Information System (INIS)

    Pasaoglu Kilanc, Guzay; Or, Ilhan

    2008-01-01

    After the liberalization of the electricity generation industry, capacity expansion decisions are made by multiple self-oriented power companies. Unlike the centralized environment, decision-making of market participants is now guided by price signal feedbacks and by an imperfect foresight of the future market conditions (and competitor actions) that they will face. In such an environment, decision makers need to better understand long-term dynamics of the supply and demand sides of the power market. In this study, a system dynamics model is developed, to better understand and analyze the decentralized and competitive electricity market dynamics in the long run. The developed simulation model oversees a 20-year planning horizon; it includes a demand module, a capacity expansion module, a power generation module, an accounting and finance module, various competitors, a regulatory body and a bidding mechanism. Many features, singularities and tools of decentralized markets, such as; capacity withholding, enforced divestment, long-term contracts, price-elastic demands, incentives/disincentives, are also incorporated into the model. Public regulators and power companies are potential users of the model, for learning and decision support in policy design and strategic planning. Results of scenario analysis are presented to illustrate potential use of the model

  13. Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America.

    Science.gov (United States)

    Ibarra-Cabrera, Ricardo; Mena-Pérez, Sandra Carolina; Bondani-Guasti, Augusto; García-Arrazola, Roeb

    2013-12-01

    The global biopharmaceutical market is worth over $100 billion USD. Nearly 90% of these products will lose their patent in the next ten years, leading to the commercialization of their subsequent versions, known as 'biosimilars'. Biosimilars are much more complex molecules than chemically synthesized generics in terms of size, structure, stability, microheterogeneity, manufacture, etc. Therefore, a specific regulatory framework is needed in order to demonstrate their comparability with innovative products, as well as their quality, safety and efficacy. The EU published the first regulatory pathway in 2005 and has approved 14 biosimilars. Mexico has recently developed a clear regulatory pathway for these products. Their legal basis was established in Article 222 Bis of General Law of Health in 2009, clear specifications in the Regulation for Health Goods in 2011, and further requirements in the Mexican Official Norm NOM-EM-001-SSA1-2012. The aim of this review is to summarize the regulatory pathways for biosimilars in the world with a special focus on Mexican experience, so as contribute to the development of regulations in other countries. Copyright © 2013 Elsevier Inc. All rights reserved.

  14. A regulatory adjustment process for the determination of the optimal percentage requirement in an electricity market with Tradable Green Certificates

    International Nuclear Information System (INIS)

    Currier, Kevin M.

    2013-01-01

    A system of Tradable Green Certificates (TGCs) is a market-based subsidy scheme designed to promote electricity generation from renewable energy sources such as wind power. Under a TGC system, the principal policy instrument is the “percentage requirement,” which stipulates the percentage of total electricity production (“green” plus “black”) that must be obtained from renewable sources. In this paper, we propose a regulatory adjustment process that a regulator can employ to determine the socially optimal percentage requirement, explicitly accounting for environmental damages resulting from black electricity generation. - Highlights: • A Tradable Green Certificate (TGC) system promotes energy production from renewable sources. • We consider an electricity oligopoly operated under a TGC system. • Welfare analysis must account for damages from “black” electricity production. • We characterize the welfare maximizing (optimal) “percentage requirement.” • We present a regulatory adjustment process that computes the optimal percentage requirement iteratively

  15. [Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].

    Science.gov (United States)

    Li, Xuelin; Tang, Jinfa; Meng, Fei; Li, Chunxiao; Xie, Yanming

    2011-10-01

    To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection. Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis. Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions. The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

  16. Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

    Science.gov (United States)

    Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

    2018-01-01

    Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

  17. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    Science.gov (United States)

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

  18. Sample size for post-marketing safety studies based on historical controls.

    Science.gov (United States)

    Wu, Yu-te; Makuch, Robert W

    2010-08-01

    As part of a drug's entire life cycle, post-marketing studies are an important part in the identification of rare, serious adverse events. Recently, the US Food and Drug Administration (FDA) has begun to implement new post-marketing safety mandates as a consequence of increased emphasis on safety. The purpose of this research is to provide exact sample size formula for the proposed hybrid design, based on a two-group cohort study with incorporation of historical external data. Exact sample size formula based on the Poisson distribution is developed, because the detection of rare events is our outcome of interest. Performance of exact method is compared to its approximate large-sample theory counterpart. The proposed hybrid design requires a smaller sample size compared to the standard, two-group prospective study design. In addition, the exact method reduces the number of subjects required in the treatment group by up to 30% compared to the approximate method for the study scenarios examined. The proposed hybrid design satisfies the advantages and rationale of the two-group design with smaller sample sizes generally required. 2010 John Wiley & Sons, Ltd.

  19. [Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring].

    Science.gov (United States)

    Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe

    2013-09-01

    To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.

  20. [The importance of defining methodology for post-marketing observational studies on cardiovascular therapies].

    Science.gov (United States)

    Pelliccia, Francesco; Barillà, Francesco; Tanzilli, Gaetano; Viceconte, Nicola; Paravati, Vincenzo; Mangieri, Enrico; Gaudio, Carlo

    2017-01-01

    In recent years, a growing number of observational studies in cardiology have been carried out following the criticism that rigid design of randomized clinical trials produces information that is not applicable to the general patient. This approach is very common in several branches of medicine, first of all oncology, but has often been considered marginal in cardiology. The recent introduction of new oral anticoagulants (NOACs) on the market, however, has seen a proliferation of "real-life" studies, drawing the attention of cardiologists to the advantages and limitations of post-marketing studies. NOACs have been approved for use on the basis of large randomized clinical trials that have clearly documented their efficacy and safety. Since they have become available, the analysis of phase IV data has been considered crucial and therefore a great amount of information on the use of NOACs in daily practice has become available. It should be considered, however, that the possibility exists that results obtained from "real-world" studies, which do not apply rigid scientific criteria, may lead to incorrect conclusions. Accordingly, it is mandatory to fully define the operational standards of observational studies. All the protagonists of post-marketing analysis (physicians, epidemiologists, pharmacologists, statisticians) should handle the data strictly in order to ensure their reliability and comparability with other studies. To this end, it is crucial that researchers follow rigorous operational protocols for phase IV studies. Briefly, any "real-life" study should be prospective and adhere to what is prespecified by the research protocol - which must illustrate the background and rationale of the study, define its primary endpoint, and detail the methods, i.e. study design, population and variables.

  1. 75 FR 47668 - Self-Regulatory Organizations; NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-08-06

    ... fierce competition for the inputs necessary to the creation of proprietary data and strict pricing..., trades, and market data itself, providing virtually limitless opportunities for entrepreneurs who wish to... and exploit this competition by sending their order flow and transaction reports to multiple markets...

  2. Market integration: The EU experience and implications for regulatory reform in China

    NARCIS (Netherlands)

    Philipsen, N.J.; Weishaar, Stefan; Xu, G.

    2016-01-01

    This book examines the relationship between regulation and market integration, with a special focus on China. It pursues a Law and Economics and Comparative Law approach (China and EU) to analyze the current obstacles to market integration and domestic economic growth in China. Topics covered at the

  3. Condom social marketing program to prevent HIV/AIDS in post-conflict Liberia.

    Science.gov (United States)

    Harris, A O; Jubwe, S; Kennedy, S B; Taylor, C H; Martin, R B; Bee, E M; Perry, O S; Massaquoi, M T; Woods, D V; Barbu, E M

    2011-08-01

    Youths in sub-Saharan Africa (SSA) account for a large burden of the global HIV/STI crises. As such, strategies directed at promoting behavioral modifications would be critical to reducing the prevalence of risky sexual behaviors among high risk adolescents in post-conflict environments. This study describes a condom promotion strategy to prevent HIV/STIs among highly vulnerable urban youth in a post-conflict, resource-constrained environment via the provision of both male and female condoms to nontraditional venues like music and photo shops, ice cream parlors, money exchange centers and beauty salons. Community members in the designated catchment areas volunteered their services and the use of their small businesses to support this endeavor. In this paper, we describe the condom promotion strategy and its implications within the context of a community-based participatory social marketing program to prevent risky sexual behaviors among highly vulnerable urban youth in a post-conflict country. We postulate that this approach may likely increase condom use among urban youth in Monrovia, the capital city of Liberia.

  4. In silico regenerative medicine: how computational tools allow regulatory and financial challenges to be addressed in a volatile market.

    Science.gov (United States)

    Geris, L; Guyot, Y; Schrooten, J; Papantoniou, I

    2016-04-06

    The cell therapy market is a highly volatile one, due to the use of disruptive technologies, the current economic situation and the small size of the market. In such a market, companies as well as academic research institutes are in need of tools to advance their understanding and, at the same time, reduce their R&D costs, increase product quality and productivity, and reduce the time to market. An additional difficulty is the regulatory path that needs to be followed, which is challenging in the case of cell-based therapeutic products and should rely on the implementation of quality by design (QbD) principles. In silico modelling is a tool that allows the above-mentioned challenges to be addressed in the field of regenerative medicine. This review discusses such in silico models and focuses more specifically on the bioprocess. Three (clusters of) examples related to this subject are discussed. The first example comes from the pharmaceutical engineering field where QbD principles and their implementation through the use of in silico models are both a regulatory and economic necessity. The second example is related to the production of red blood cells. The described in silico model is mainly used to investigate the manufacturing process of the cell-therapeutic product, and pays special attention to the economic viability of the process. Finally, we describe the set-up of a model capturing essential events in the development of a tissue-engineered combination product in the context of bone tissue engineering. For each of the examples, a short introduction to some economic aspects is given, followed by a description of the in silico tool or tools that have been developed to allow the implementation of QbD principles and optimal design.

  5. Regulatory inhibition of biological tissue mineralization by calcium phosphate through post-nucleation shielding by fetuin-A

    Energy Technology Data Exchange (ETDEWEB)

    Chang, Joshua C., E-mail: joshchang@ucla.edu [Clinical Center, National Institutes of Health, Bethesda, Maryland 20892, USA and Mathematical Biosciences Institute, The Ohio State University, Columbus, Ohio 43210 (United States); Miura, Robert M., E-mail: miura@njit.edu [Department of Mathematical Sciences, New Jersey Institute of Technology, Newark, New Jersey 07102 (United States)

    2016-04-21

    In vertebrates, insufficient availability of calcium and inorganic phosphate ions in extracellular fluids leads to loss of bone density and neuronal hyper-excitability. To counteract this problem, calcium ions are usually present at high concentrations throughout bodily fluids—at concentrations exceeding the saturation point. This condition leads to the opposite situation where unwanted mineral sedimentation may occur. Remarkably, ectopic or out-of-place sedimentation into soft tissues is rare, in spite of the thermodynamic driving factors. This fortunate fact is due to the presence of auto-regulatory proteins that are found in abundance in bodily fluids. Yet, many important inflammatory disorders such as atherosclerosis and osteoarthritis are associated with this undesired calcification. Hence, it is important to gain an understanding of the regulatory process and the conditions under which it can go awry. In this manuscript, we extend mean-field continuum classical nucleation theory of the growth of clusters to encompass surface shielding. We use this formulation to study the regulation of sedimentation of calcium phosphate salts in biological tissues through the mechanism of post-nuclear shielding of nascent mineral particles by binding proteins. We develop a mathematical description of this phenomenon using a countable system of hyperbolic partial differential equations. A critical concentration of regulatory protein is identified as a function of the physical parameters that describe the system.

  6. Regulatory changes and market volatility -- Continuing uncertainties in the reformulated gasoline program

    International Nuclear Information System (INIS)

    Thompson, R.P.

    1995-01-01

    The paper discusses the reformulated gasoline market. After several years of discussions, negotiations, and planning on the parts of the oil industry, EPA, and the New York Mercantile Exchange, the introduction of reformulated gasoline was executed without problems. Ample inventories were in place for distribution in December and January. Then 28 counties in Pennsylvania, 9 in New York, and 2 in Maine made requests to opt-out of the reformulated gasoline program. EPA, 10 days later, allowed this. The paper describes what this inadequate notice of the reversal of regulations had on the futures market and the uncertainties still in the market

  7. Regulatory Barriers for Flexible Coupling of the Nordic Power and District Heating Markets

    DEFF Research Database (Denmark)

    Skytte, Klaus; Olsen, Ole Jess

    2016-01-01

    that the choice of technologies for heat generation is mainly driven by outdated policies and tax conditions that create barriers for additional flexibility in the overall energy system. However, the balancing markets may be a main driver for introducing more electric boilers into DH and thereby increase its......Large share of variable renewable energy sources (VRE) is being deployed in the Nordic countries, especially wind power. This calls for additional flexibility of the power market. With the right coupling to the underlying national and local district heating (DH) markets, large shares of flexibility...

  8. U.S. regulatory and market issues in developing east coast gas

    International Nuclear Information System (INIS)

    Madden, K.P.

    1998-01-01

    Significant market-oriented changes in natural gas regulation were reviewed, and the influence of these changes on the recent boom in the natural gas industry were evaluated. It was noted that the regulators' role in certifying new projects must reflect market-driven priorities. Parallels in the competitive natural gas markets on both sides of the Canadian-U.S. border were explored. It was noted that currently some of the most significant influences in the certification process in the U.S. are environmental and landowner concerns. The growth in landowner concerns was considered healthy, based on the argument that the natural tension between efforts of regulators to minimize environmental impact and granting potentially duplicative project licences can be seen as the instrument that allows the market to decide winners and losers. The current status of pending east coast projects in the U.S. was also reviewed

  9. Regulatory Approval Decisions in the Presence of Market Externalities: The Case of Genetically Modified Wheat

    OpenAIRE

    Furtan, William Hartley; Gray, Richard S.; Holzman, J.J.

    2005-01-01

    This study examines the optimal approval strategy for genetically modified (GM) wheat varieties in Canada and the United States. Without an affordable segregation system, the introduction of GM wheat will create a market for "lemons" that will result in the loss of important export markets. Using a differentiated product trade model for spring wheat, with endogenous technology pricing, a payoff matrix is generated for the possible approval outcomes. Results show that the existence of the mark...

  10. Regulatory intervention on the dynamic European gas market. Neoclassical economics or transaction cost economics?

    International Nuclear Information System (INIS)

    Spanjer, Aldo R.

    2009-01-01

    Shifts at the international gas market indicate that the transaction cost perspective provides better underpinnings for European gas regulation than the current neoclassical perspective. Three implications are that policymakers should: (1) allow alternative coordination measures to complement market exchange; (2) recognize that less than perfect competition outcomes may be optimal and (3) be more reticent in prescribing interventionist measures. Finally, the analysis provides the foundations for the empirical research required to complement this paper's theoretical approach. (author)

  11. An Analysis of Malaysia’s Regulatory Framework and Challenges in the Structured Product Market

    OpenAIRE

    Ling, Eu Meng

    2008-01-01

    Structured products are becoming increasingly popular and important to the development of Malaysia’s capital market and had experience impressive growth over the last few years after it was first introduced to the Malaysian market in 2004. Like any industry in its early stage, issues and challenges are expected but for structured products, such challenges require more attention due to the complexity inherent in these instruments. This study uses a qualitative research approach in an attempt t...

  12. Regulatory Options for Local Reserve Energy Markets: Implications for Prosumers, Utilities, and other Stakeholders

    OpenAIRE

    Rosen, Christiane; Madlener, Reinhard

    2014-01-01

    While the share of fluctuating renewable energy resources is constantly increasing, the centralized, hierarchical organization of the current energy system cannot adequately accommodate such decentralized electricity generation. New ideas have been developed for improved integration, especially in the lead market Germany. One of these concepts is the microgrid, a grid within the grid. This paper presents a local reserve energy market, which can facilitate the operation and allow trading withi...

  13. Regulatory supply and market demand of risk management: Match or clash?

    Directory of Open Access Journals (Sweden)

    Christoph Van der Elst

    2011-03-01

    Full Text Available The paper raises questions as to whether the new risk governance requirements will be able to match the prerequisites for more balanced risk governance as part of the decision making process while fostering business entrepreneurship. Further, to comfort the market it will be necessary to report in accordance with market expectations adequate information about the financial and non-financial risks internal and external risks the companies is coping. Both questions will be addressed in this paper.

  14. Use of carabids for the post-market environmental monitoring of genetically modified crops

    Czech Academy of Sciences Publication Activity Database

    Skoková Habuštová, Oxana; Svobodová, Zdeňka; Cagáň, Ľ.; Sehnal, František

    2017-01-01

    Roč. 9, č. 4 (2017), č. článku 121. E-ISSN 2072-6651 R&D Projects: GA MŠk(CZ) 7AMB14SK096 Grant - others:projekt VEGA(SK) 1/0732/14; GA ČR(CZ) L200961652 Institutional support: RVO:60077344 Keywords : Carabidae * surrogate * post-market environmental monitoring Subject RIV: GF - Plant Pathology, Vermin, Weed, Plant Protection OBOR OECD: GM technology (crops and livestock), livestock cloning, marker assisted selection, diagnostics (DNA chips and biosensing devices for the early/accurate detection of diseases) biomass feedstock production technologies, biopharming Impact factor: 3.030, year: 2016 http://www.mdpi.com/2072-6651/9/4/121

  15. Decision support methods for the detection of adverse events in post-marketing data.

    Science.gov (United States)

    Hauben, M; Bate, A

    2009-04-01

    Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical measures of reporting frequency for huge numbers of drug-event combinations are increasingly used to support pharamcovigilance analysts screening large spontaneous reporting system databases. After an overview of pharmacovigilance and spontaneous reporting systems, we discuss the theory and application of contemporary computer algorithms in regular use, those under development, and the practical considerations involved in the implementation of computer algorithms within a comprehensive and holistic drug safety signal detection program.

  16. Regulatory Design of Capacity Remuneration Mechanisms in Regional and Low-Carbon Electric Power Markets

    NARCIS (Netherlands)

    Mastropietro, P.

    2016-01-01

    Capacity remuneration mechanisms (CRMs) are “climbing” regulatory agendas in all liberalised power sectors, especially in the European Union. CRMs are introduced to improve system reliability and to minimise power shortages to an economically efficient extent. These schemes will have a central role

  17. [Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

  18. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    Science.gov (United States)

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  19. Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

    Science.gov (United States)

    Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

    2018-01-01

    Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

  20. National post-market surveillance assessment of veterinary medicines in Korea during the past decade.

    Science.gov (United States)

    Kang, JeongWoo; Park, Hae-Chul; Jang, Yang Ho; Hossain, Md Akil; Jeong, Kyunghun; Jeong, Mi Young; Yun, Seon-Jong; Park, Sung-Won; Kim, Dae Gyun; Lee, Kwang-Jick

    2017-05-22

    Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine. In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the "national post-market surveillance (NPMS) system" over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A. The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good

  1. [Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

    Science.gov (United States)

    Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

    2018-02-01

    To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

  2. Incorporating Spirituality and Market: Islamic Sharia Business and Religious Life in Post-New Order Indonesia

    Directory of Open Access Journals (Sweden)

    Wildan Sena Utama

    2016-06-01

    Full Text Available 0 0 1 154 880 wildan 7 2 1032 14.0 Normal 0 false false false EN-US JA X-NONE Artikel ini membahas tentang transformasi religious kelas menengah Indonesia danhubungannya dengan pertumbuhan pasar syariah pada pasca-Orde Baru di Indonesia.Artikel ini berpendapat bahwa dalam era neoliberal Indonesia, kebangkitan spiritualini sangat memengaruhi ranah ekonomi. Transformasi kesalehan kelas menengahIndonesia menandai munculnya potensi pasar ekonomi baru. Hal itu direspon secaraantusias oleh pasar dengan memproduksi produk yang selektif berisi konten spiritual.Dalam prosesnya, peran para agen gaya hidup spiritual memainkan peranan pentingdalam membantu dan membentuk kelas menengah urban baru ini dalam mengonsumsiIslam untuk menandakan identitas keislaman mereka. Kemudian muncullah perpaduanaktif antara kesalehan Islam dan kapitalisme dalam situasi Indonesia kontemporer.Konsumsi simbolis Islam menjadi sumber baru dari spiritualisme maupun sumber dariidentifikasi religius. Akan tetapi, artikel ini berpendapat bahwa proses ini cenderungmenyederhanakan Islam sebagai ‘prosesi material’ daripada ‘prosesi spiritual’. This article examines the religious transformation of the Muslim middle class and itsrelationship with the growing sharia market in post-New Order Indonesia. It arguesthat in the Indonesian neo-liberal era, this spiritual revival considerably influenced theeconomic realm. The transformation of piety of the Indonesian middle class markedthe emergence of new potential economic markets. It was responded to enthusiasticallyby markets producing selective products with a spiritual content. In its process, therole of spiritual lifestyle agents played a pivotal role in helping and shaping the newurban middle class who consume Islam to mark their Islamic identity. It was then thatthe energetic blending between Islamic piety and capitalism occurred in contemporaryIndonesia. Islamic symbolic consumption becomes a new source of spiritualism as wellas

  3. Environmental change challenges decision-making during post-market environmental monitoring of transgenic crops.

    Science.gov (United States)

    Sanvido, Olivier; Romeis, Jörg; Bigler, Franz

    2011-12-01

    The ability to decide what kind of environmental changes observed during post-market environmental monitoring of genetically modified (GM) crops represent environmental harm is an essential part of most legal frameworks regulating the commercial release of GM crops into the environment. Among others, such decisions are necessary to initiate remedial measures or to sustain claims of redress linked to environmental liability. Given that consensus on criteria to evaluate 'environmental harm' has not yet been found, there are a number of challenges for risk managers when interpreting GM crop monitoring data for environmental decision-making. In the present paper, we argue that the challenges in decision-making have four main causes. The first three causes relate to scientific data collection and analysis, which have methodological limits. The forth cause concerns scientific data evaluation, which is controversial among the different stakeholders involved in the debate on potential impacts of GM crops on the environment. This results in controversy how the effects of GM crops should be valued and what constitutes environmental harm. This controversy may influence decision-making about triggering corrective actions by regulators. We analyse all four challenges and propose potential strategies for addressing them. We conclude that environmental monitoring has its limits in reducing uncertainties remaining from the environmental risk assessment prior to market approval. We argue that remaining uncertainties related to adverse environmental effects of GM crops would probably be assessed in a more efficient and rigorous way during pre-market risk assessment. Risk managers should acknowledge the limits of environmental monitoring programmes as a tool for decision-making.

  4. Post-Transcriptional Regulation by the Csr Global Regulatory System in Escherichia coli

    OpenAIRE

    Suzuki, Kazushi; 鈴木, 一史

    2007-01-01

    In many species of bacteria, the Csr (carbon storage regulator) global regulatory system coordinates the expression of various genes. In Escherichia coli, the central component of this system, CsrA, is a RNA-binding protein. The CsrA is a homodimer and binds to leader segments of target mRNAs, affecting their translation and stability. CsrA activity is regulated by two small non-coding RNAs, CsrB and CsrC. These RNAs contain multiple CsrA-binding sequences and act by sequestering CsrA. In thi...

  5. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    Science.gov (United States)

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

  6. The post-transcriptional regulatory system CSR controls the balance of metabolic pools in upper glycolysis of Escherichia coli.

    Science.gov (United States)

    Morin, Manon; Ropers, Delphine; Letisse, Fabien; Laguerre, Sandrine; Portais, Jean-Charles; Cocaign-Bousquet, Muriel; Enjalbert, Brice

    2016-05-01

    Metabolic control in Escherichia coli is a complex process involving multilevel regulatory systems but the involvement of post-transcriptional regulation is uncertain. The post-transcriptional factor CsrA is stated as being the only regulator essential for the use of glycolytic substrates. A dozen enzymes in the central carbon metabolism (CCM) have been reported as potentially controlled by CsrA, but its impact on the CCM functioning has not been demonstrated. Here, a multiscale analysis was performed in a wild-type strain and its isogenic mutant attenuated for CsrA (including growth parameters, gene expression levels, metabolite pools, abundance of enzymes and fluxes). Data integration and regulation analysis showed a coordinated control of the expression of glycolytic enzymes. This also revealed the imbalance of metabolite pools in the csrA mutant upper glycolysis, before the phosphofructokinase PfkA step. This imbalance is associated with a glucose-phosphate stress. Restoring PfkA activity in the csrA mutant strain suppressed this stress and increased the mutant growth rate on glucose. Thus, the carbon storage regulator system is essential for the effective functioning of the upper glycolysis mainly through its control of PfkA. This work demonstrates the pivotal role of post-transcriptional regulation to shape the carbon metabolism. © 2016 John Wiley & Sons Ltd.

  7. A flexible regulatory framework

    International Nuclear Information System (INIS)

    Silvennoinen, T.

    2000-01-01

    Regulatory reform of the Finnish electricity market meant opening up potentially competitive parts of the electricity sector to competition and eliminating all unnecessary forms of regulation covering generation, wholesale supply, retail supply, and foreign trade in electricity. New types of control and regulatory mechanisms and institutions were set up for those parts of the electricity industry that were excluded from competition, such as network operations. Network activities now have to be licensed, whereas no licence is needed for generation or supply. A new sector-specific regulatory authority was established in 1995 to coincide with the implementation of the Electricity Market Act, known as the Electricity Market Authority. This is responsible for regulating network activities and retail supply to captive customers. The core function of the authority, which employs some 14 people, is to promote the smooth operation of the Finnish electricity market and to oversee the implementation of the Electricity Market Act and its provisions. Its most important duties are linked to overseeing the process by which network companies price their electricity. As price regulation no longer exists, all the companies in the electricity sector set their tariffs independently, even network companies. The job of controlling the pricing of network services is handed by the Electricity Market Authority, following the principles of competition control. Pricing control takes place ex post - after a pricing system has been adopted by a company and concentrates on individual cases and companies. There is no ex ante system of setting or approving prices and tariffs by the regulator. The tariffs and pricing of network services can be evaluated, however, by both the Electricity Market Authority and the Finnish Competition Authority, which have overlapping powers as regards the pricing of network activities. The Finnish regulatory framework can be described as a system of light

  8. 77 FR 52887 - Regulatory Capital Rules: Standardized Approach for Risk-Weighted Assets; Market Discipline and...

    Science.gov (United States)

    2012-08-30

    ... Discipline and Disclosure Requirements; Proposed Rule #0;#0;Federal Register / Vol. 77 , No. 169 / Thursday... Assets; Market Discipline and Disclosure Requirements AGENCY: Office of the Comptroller of the Currency... Approach NPR) includes proposed changes to the agencies' general risk-based capital requirements for...

  9. 76 FR 57791 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Instituting Proceedings To...

    Science.gov (United States)

    2011-09-16

    ..., 2011. I. Introduction On May 26, 2011, The NASDAQ Stock Market LLC (``Nasdaq'' or ``Exchange'') filed... concerns, including accounting fraud allegations that have recently arisen with respect to Reverse Merger... fraudulent behavior by certain Reverse Merger companies, leading to concerns that their financial statements...

  10. Financial Investment Management: Testing the Market Model on the Romanian Capital Market during the Post Financial Crisis

    Directory of Open Access Journals (Sweden)

    Radu CIOBANU

    2011-06-01

    Full Text Available This article presents an analysis of the decision of investing in the capital market in Romania during 2009-2010, in the context of overcoming the global financial crisis. In the first part of the paper, we have made a brief presentation of the simplified model of market analysis introduced in the specialized literature by William Sharpe, the respective model representing the starting point in our study. The purpose of the present study is to emphasize how the evolutions of the financial securities rates listed on the Bucharest Stock Exchange could be explained based on the evolution of BET Romanian capital market index. Although the study over this phenomenon has begun in the middle of the last century, every day new studies appear that are either coming in addition to the already existing ones or are bringing a new approach regarding the financial theory. The novelty of the present study conducted by us resides in the highlighting of the evolutions of the financial securities rates during July 2009 – December 2010 periods. The second part of the paper presents the results of a study conducted on the Romanian capital market, emphasizing the correlations between the most important securities on the Romanian capital market, as parts of BET index and market index. The aim is to check whether during this period the evolution of the financial securities’ return can be explained more or less by the return of the capital market.

  11. Do marketing and alcohol treatment/public health experts think televised alcohol advertisements abide by regulatory guidelines?

    Science.gov (United States)

    Lloyd, Kelly; Cameron, Elaine; Williams, Hannah; Banister, Emma; Donmall, Michael; Higgins, Alan; French, David P

    2018-04-01

    Televised alcohol advertisements in the United Kingdom must abide by the Broadcast Committee of Advertising Practice Code, which provides guidelines concerning advertisements not implying, condoning or encouraging immoderate, irresponsible or antisocial drinking. Previously, 75 per cent of 373 general public respondents were shown one of seven advertisements rated a breach of at least one guideline. This study assessed whether experts in marketing ( n = 25) and alcohol treatment/public health ( n = 25) perceived the same seven television alcohol advertisements as complying with the Broadcast Committee of Advertising Practice Code. Overall, 83 per cent of advertisements were rated as breaching at least one guideline. This provides further proof that self-regulatory alcohol guidelines are not fit for purpose.

  12. Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Industry

    Science.gov (United States)

    Wheelahan, Leesa; Buchanan, John; Yu, Serena

    2015-01-01

    This summary brings together the relevant key findings for industry from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education and training (VET) and…

  13. Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Qualification & Approval Bodies

    Science.gov (United States)

    Wheelahan, Leesa; Buchanan, John; Yu, Serena

    2015-01-01

    This summary pulls together the relevant key findings for qualification and approval bodies from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education…

  14. Economics and business administration post-graduates in transition from university to work: Labor market success factors

    NARCIS (Netherlands)

    Bijker, Monique; Van der Klink, Marcel; Boshuizen, Els

    2012-01-01

    Bijker, M. M., Van der Klink, M. R., & Boshuizen, H. P. A. (2012, 13-17 April). Economics and business administration post-graduates in transition from university to work: Labor market success factors. Paper presented at the Annual Meeting of the American Education Research Association (AERA),

  15. Mining association patterns of drug-interactions using post marketing FDA's spontaneous reporting data.

    Science.gov (United States)

    Ibrahim, Heba; Saad, Amr; Abdo, Amany; Sharaf Eldin, A

    2016-04-01

    Pharmacovigilance (PhV) is an important clinical activity with strong implications for population health and clinical research. The main goal of PhV is the timely detection of adverse drug events (ADEs) that are novel in their clinical nature, severity and/or frequency. Drug interactions (DI) pose an important problem in the development of new drugs and post marketing PhV that contribute to 6-30% of all unexpected ADEs. Therefore, the early detection of DI is vital. Spontaneous reporting systems (SRS) have served as the core data collection system for post marketing PhV since the 1960s. The main objective of our study was to particularly identify signals of DI from SRS. In addition, we are presenting an optimized tailored mining algorithm called "hybrid Apriori". The proposed algorithm is based on an optimized and modified association rule mining (ARM) approach. A hybrid Apriori algorithm has been applied to the SRS of the United States Food and Drug Administration's (U.S. FDA) adverse events reporting system (FAERS) in order to extract significant association patterns of drug interaction-adverse event (DIAE). We have assessed the resulting DIAEs qualitatively and quantitatively using two different triage features: a three-element taxonomy and three performance metrics. These features were applied on two random samples of 100 interacting and 100 non-interacting DIAE patterns. Additionally, we have employed logistic regression (LR) statistic method to quantify the magnitude and direction of interactions in order to test for confounding by co-medication in unknown interacting DIAE patterns. Hybrid Apriori extracted 2933 interacting DIAE patterns (including 1256 serious ones) and 530 non-interacting DIAE patterns. Referring to the current knowledge using four different reliable resources of DI, the results showed that the proposed method can extract signals of serious interacting DIAEs. Various association patterns could be identified based on the relationships among

  16. Post-marketing surveillance of OraQuick whole blood and oral fluid rapid HIV testing.

    Science.gov (United States)

    Wesolowski, Laura G; MacKellar, Duncan A; Facente, Shelley N; Dowling, Teri; Ethridge, Steven F; Zhu, Julia H; Sullivan, Patrick S

    2006-08-01

    Post-marketing surveillance was conducted to monitor the performance of the OraQuick Advance rapid HIV-1/2 antibody test (OraQuick) on whole blood and oral fluid. Surveillance of routinely collected data on clients tested with OraQuick in 368 testing sites affiliated with 17 state and city health departments between 11 August 2004 and 30 June 2005. For whole blood and oral fluid, we report the median (range) health department OraQuick specificity and positive predictive value (PPV), and the number of clients with discordant results (e.g. who had a reactive rapid test not confirmed positive by Western blot or indirect immunofluorescence). At one site with lower than expected oral-fluid specificity, we evaluated whether device expiration, manufacturing lot, operator practices, or device-storage or testing-area temperatures were associated with false-positive tests. During the surveillance period, 135 724 whole blood and 26 066 oral fluid rapid tests were conducted. The median health department whole blood OraQuick specificity was 99.98% (range: 99.73-100%) and PPV was 99.24% (range: 66.67-100%); the median oral fluid specificity was 99.89% (range: 99.44-100%) and PPV was 90.00% (range: 50.00-100%). A total of 124 discordant results were reported from 68 (0.05%) whole blood and 56 (0.22%) oral fluid rapid tests. The oral fluid specificity at the site with excess oral fluid false-positive tests was 98.7% (95% confidence interval: 98.18-99.11%). The increase in false-positive tests at that site was not associated with any specific device characteristic, operator procedure or temperature condition. The specificity of OraQuick performed on whole blood and oral fluid during post-marketing surveillance was compatible with the manufacturer's claim within the package insert. However, one site experienced lower than expected oral fluid specificity. Sites that observe that the specificity of OraQuick is lower than the range indicated in the package insert should notify the

  17. Survey of Regulatory and Technological Developments Concerning Smart Metering in the European Union Electricity Market

    OpenAIRE

    VASCONCELOS, Jorge

    2008-01-01

    Smart metering is a crucial factor for the efficient functioning of the Internal Electricity Market, as well as for the successful implementation of European Union policies related to energy efficiency, renewable energy and security of supply. The report first outlines the potential benefits of smart meters for consumers, suppliers, metering companies, distribution network operators and public interest. Next the report provides a short overview of the legal framework governing metering activi...

  18. Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

    Science.gov (United States)

    Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

    2017-10-01

    This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

  19. Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

    Science.gov (United States)

    Sakoulas, G

    2009-12-01

    The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

  20. A temporal interestingness measure for drug interaction signal detection in post-marketing surveillance.

    Science.gov (United States)

    Ji, Yanqing; Ying, Hao; Tran, John; Dews, Peter; Mansour, Ayman; Massanari, R Michael

    2014-01-01

    Drug-drug interactions (DDIs) can result in serious consequences, including death. Existing methods for identifying potential DDIs in post-marketing surveillance primarily rely on the FDA's (Food and Drug Administration) spontaneous reporting system. However, this system suffers from severe underreporting, which makes it difficult to timely collect enough valid cases for statistical analysis. In this paper, we study how to signal potential DDIs using patient electronic health data. Specifically, we focus on discovery of potential DDIs by analyzing the temporal relationships between the concurrent use of two drugs of interest and the occurrences of various symptoms using novel temporal association mining techniques we developed. A new interestingness measure called functional temporal interest was proposed to assess the degrees of temporal association between two drugs of interest and each symptom. The measure was employed to screen potential DDIs from 21,405 electronic patient cases retrieved from the Veterans Affairs Medical Center in Detroit, Michigan. The preliminary results indicate the usefulness of our method in finding potential DDIs for further analysis (e.g., epidemiology study) and investigation (e.g., case review) by drug safety professionals.

  1. Effectiveness and tolerability of parenteral testosterone undecanoate: a post-marketing surveillance study.

    Science.gov (United States)

    Wolf, Jan; Keipert, Dieter; Motazedi, Heiko; Ernst, Michael; Nettleship, Joanne; Gooren, Louis

    2017-12-01

    This observational post-marketing study of parenteral testosterone undecanoate (TU) in a non-selected population aimed to: examine the effectiveness of TU as treatment of hypogonadism; record adverse drug reactions (ADR) quantitatively particularly regarding polycythemia, prostate safety and cardiovascular-related metabolic risk factors; and verify whether recommended injection intervals apply to routine clinical practice. Eight hundred and seventy subjects from 259 outpatient units scheduled to visit the clinic six times were included. Effectiveness and tolerability of TU administration were assessed on a 4-point scale. Body weight, waist girth, blood pressure, hemoglobin levels, hematocrit, prostate-specific antigen (PSA), and digital rectal prostate examination were assessed. Over 90% of subjects completed the observational duration of 52.8 ± 9.7 weeks (mean ± SD) and 56% judged effectiveness as very good, 30.8% as good. 63.1% judged tolerability as very good, and 24.4% as good. No adverse effects on indicators of cardiovascular risk were observed. Polycythemia occurred in one subject and a supranormal hematocrit in one subject. Four subjects developed supranormal PSA levels. Prostate carcinoma was found in one subject, one subject had recurrence of a previously surgically treated prostate carcinoma, and the other two showed no indication of malignancy. Parenteral TU is safe, effective, and well-tolerated in clinical practice proving a good therapeutic option for hypogonadism.

  2. [The role of drug registries in the post-marketing surveillance].

    Science.gov (United States)

    Traversa, Giuseppe; Sagliocca, Luciano; Magrini, Nicola; Venegoni, Mauro

    2013-06-01

    The aim of this article is to provide an introduction to issue of Recenti Progressi in Medicina, devoted to the role of drug registries in the post-marketing surveillance. We first motivate the need to implement registries as a tool in promoting the appropriateness of drug use and acquiring additional information on the risk-benefit profile of drugs. Then, the different role that can be played by registries in comparison with prescription monitoring systems and observational studies is clarified. The presentation of some of the most relevant registries established in Italy since the end of the '90s, with the analysis of their strengths and weaknesses, helps to understand some of the crucial issues that should be taken into account before a new registry is adopted. Specifically, we deal with the relationship between objectives - of appropriateness, effectiveness and safety - and methods; the overlapping between drug-based registries and disease-based ones; the duration and extension of data collection, which may be either exhaustive or based on a sampling frame; the importance of ensuring the quality of the data and to minimize the number of subjects who are lost to follow-up; the importance of infrastructures, and of ad hoc funding, for the functioning of a registry; the independence in data analysis and publication of findings.

  3. A post-marketing study of gadodiamide hydrate in patients with cerebral infarction

    International Nuclear Information System (INIS)

    Ono, Yuko; Aoki, Shigeki

    2003-01-01

    We evaluated the efficacy and safety of gadodiamide hydrate (GH: Omuniscan) in patients with cerebral infarction in a multicenter post-marketing study. A total of 122 patients enrolled in this study at 16 institutions in throughout Japan. We administrated GH to patients intravenously at 0.2 mL/kg, an approved usage and dosage for head MRI. Efficacy was evaluated by comparing contrast intensity and diagnostic improvement on T1WI before and after the administration of GH and diagnostic significance was investigated. Moreover, clinical data thus obtained were compared with those of phase III studies of GH and other contrast agents with respect to general evaluation of diagnostic improvement. The effects of contrast enhancement on the detection and extent of lesions as well as image quality were judged in terms of improving general evaluation and diagnosis, which was observed in 93.3% of the patients. No serious adverse event were associated with GH administration. The efficacy of GH in this clinical trial was higher, than historical data, with respect to general evaluation and diagnostic improvement. Contrast enhanced MRI with GH in cerebral infarction was confirmed to be of diagnostic value. (author)

  4. Use of Carabids for the Post-Market Environmental Monitoring of Genetically Modified Crops

    Directory of Open Access Journals (Sweden)

    Oxana Skoková Habuštová

    2017-03-01

    Full Text Available Post-market environmental monitoring (PMEM of genetically modified (GM crops is required by EU legislation and has been a subject of debate for many years; however, no consensus on the methodology to be used has been reached. We explored the suitability of carabid beetles as surrogates for the detection of unintended effects of GM crops in general PMEM surveillance. Our study combines data on carabid communities from five maize field trials in Central Europe. Altogether, 86 species and 58,304 individuals were collected. Modeling based on the gradual elimination of the least abundant species, or of the fewest categories of functional traits, showed that a trait-based analysis of the most common species may be suitable for PMEM. Species represented by fewer than 230 individuals (all localities combined should be excluded and species with an abundance higher than 600 should be preserved for statistical analyses. Sixteen species, representing 15 categories of functional traits fulfill these criteria, are typical dominant inhabitants of agroecocoenoses in Central Europe, are easy to determine, and their functional classification is well known. The effect of sampling year is negligible when at least four samples are collected during maize development beginning from 1 April. The recommended methodology fulfills PMEM requirements, including applicability to large-scale use. However, suggested thresholds of carabid comparability should be verified before definitive conclusions are drawn.

  5. Institutional and Regulatory Economics of Electricity Market Reforms: the Evidence from India, Pakistan, Bangladesh, Nepal, and Sri Lanka

    Science.gov (United States)

    Singh, Bipulendu

    Five South Asian countries-- India, Pakistan, Bangladesh, Nepal and Sri Lanka -- embarked on electricity market reforms in the 1990's. The dissertation uses the framework of New Institutional Economics to assess the effects on electricity sector performance of both observables elements of reform (i.e. privatization, unbundling, establishment of independent regulatory agencies etc.) as well as the unobservable elements (informal beliefs, habit, norms and culture of the actors involved in reforms). The first part of the dissertation -- econometric analysis of the relationship between observable electricity market reform measures and performance indicators -- finds that for the most part electricity market reforms in South Asia are having a positive impact on the performance of the sector. This is particularly the case for reforms that have increased private sector participation in generation and distribution and have vertically unbundled utilities into generation, transmission and distribution entities. Many of the reforms are positively correlated with higher tariffs, indicating a cost to the consumers from the reforms. The relationship between independent regulation and performance indicators , however, is not established. The second part of the dissertation - analytical narrative of the reform experiences of Gujarat and Nepal -- examines the informal elements (such as beliefs, norms, culture) that motivate behavior and explains how and why reform outcomes differed in these two places. The dissertation finds that the strength of formal institutions rules and the nature of social norms and customs have a significant influence on the outcome of reforms. Aided by the strength of its formal institutional framework and more evolved social norms and customs that encouraged people to follow formal rules, reforms in the Indian state of Gujarat were a success. The weakness of the formal institutional framework and the predominance of relation-based norms and customs in

  6. Depressive symptoms, post-traumatic stress symptoms and suicide risk among graduate students: The mediating influence of emotional regulatory self-efficacy.

    Science.gov (United States)

    Zeng, Baoer; Zhao, Jiubo; Zou, Laiquan; Yang, Xueling; Zhang, Xiaoyuan; Wang, Wanjun; Zhao, Jingbo; Chen, Jie

    2018-06-01

    The current study was to examine the relationship among depressive symptoms, post-traumatic stress symptoms, emotion regulatory self-efficacy and suicide risk. A cross-sectional survey was conducted among 3257 graduate students from a medical college of China. Lifetime prevalence of suicidal ideation, plan and attempt were 25.7%, 1.6%, 1.1%, respectively, with one-year suicidal ideation showing at 6.3%. Structural equation modeling was employed to examine the relative contribution of depressive symptoms, post-traumatic stress symptoms and emotion regulatory self-efficacy on suicide risk. Structural equation model had a highly satisfactory fit [χ 2  = 7.782, df = 4, p = 0.096; RMSEA = 0.021; CFI = 0.992; GFI = 0.997]. Post-traumatic stress symptoms had a direct effect and an indirect effect on suicide risk via emotion regulatory self-efficacy. Depressive symptoms also had a direct effect and an indirect effect on suicide risk via emotion regulatory self-efficacy. The depressive and post-traumatic stress symptoms increased the risk of suicide risk, but the variable of emotion regulatory self-efficacy would be served as a buffering factor, decreasing the risk of suicide. The interaction term of depressive symptoms and post-traumatic stress symptoms had a direct effect on suicide risk. A significant interactive effect of depressive and post-traumatic stress symptoms on suicide risk was found. Copyright © 2018 Elsevier B.V. All rights reserved.

  7. Food marketing to children in India: comparative review of regulatory strategies across the world.

    Science.gov (United States)

    Bhatnagar, Nidhi; Kaur, Ravneet; Dudeja, Puja

    2014-11-01

    Food marketing directed to children is an issue of concern in the present day society. Revolution in food industry, increasing globalization and boom in information technology has introduced various types of food products and the way they are placed in front of likely consumers. This has resulted in rising trend of obesity and switch from communicable to non-communicable diseases, which is not cost effective for nation as a whole. Multinational companies have targeted children as a naïve audience to boost their sales. In-ethical practice of misleading claims in the advertisements is instrumental in many cases. Food marketing to children has been assumed a public health threat since times of yore. World Health Organization has resolutions and recommendations on this subject. Member countries, including India are a signatory to this declaration. However, much needs to be done to counter these multinational food giants. Regulations and policies need to be enforced at national and institutional levels. Parents must be educated; schools and social organizations to be made proactive on this aspect.

  8. Welfare distribution effect of a price reduction in the Dutch gas transport market: A scenario analysis of regulatory policy, market form and rent allocation

    International Nuclear Information System (INIS)

    Van Witteloostuijn, Arjen; Van Marrewijk, Charles

    2007-01-01

    As part of the larger energy market deregulation program, the Dutch energy authority - DTe - has developed the habit to force the Dutch gas transport enterprise - Gas Transport Services, or GTS - to lower its prices. DTe's key argument is that lower gas transport prices will benefit the end-user. Indeed, that might well be the case. This policy, in general, is in line with European legislation on the liberalization of the gas market. We model and simulate the (domestic) welfare effects of a 5 percent transport price reduction. From this, we conclude that at least three observations complicate matters substantially. First, GTS is government-owned, and the dominant shipper - Gasunie Trade and Supply (or GasTerra, as it was recoined recently) - is partly so (50%). Second, shippers enter into the competitive game to make profits. Third, not only is the majority of gas transported in the Netherlands exported to foreign end-users, but also foreign owners have a large stake in Dutch shippers. As a result, part of the rents will always be distributed, or will 'leak' away, to foreign consumers and shippers (or their shareholders). These three observations together have three important implications. First, state ownership implies that much rent allocation is simply a matter of circulating money from one government sub-budget to the other. Second, given that the industry is imperfectly competitive, part of the rents will not be passed on to the end-consumers. Third, it is unavoidable that a substantial part of the rents are transferred abroad. A general conclusion for policy-makers is that market liberalization might not bring ex post what they expected ex ante. (author)

  9. Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk.

    Science.gov (United States)

    Raschi, Emanuel; De Ponti, Fabrizio

    2015-07-08

    Drug-induced liver injury (DILI) and herb-induced liver injury is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications in the past 15 years. This review will first provide clues for clinicians to suspect idiosyncratic (unpredictable) DILI and succeed in diagnosis. Causality assessment remains challenging and requires careful medical history as well as awareness of multifaceted aspects, especially for herbs. Drug discontinuation and therapy reconciliation remain the mainstay in patent's management to minimize occurrence of acute liver failure. The second section will address novel agents associated with liver injury in 2014 (referred to as "signals"), especially in terms of clinical, research and drug development implications. Insights will be provided into recent trends by highlighting the contribution of different post-marketing data, especially registries and spontaneous reporting systems. This literature scrutiny suggests: (1) the importance of post-marketing databases as tools of clinical evidence to detect signals of DILI risk; and (2) the need for joining efforts in improving predictivity of pre-clinical assays, continuing post-marketing surveillance and design ad hoc post-authorization safety studies. In this context, ongoing European/United States research consortia and novel pharmaco-epidemiological tools (e.g., specialist prescription event monitoring) will support innovation in this field. Direct oral anticoagulants and herbal/dietary supplements appear as key research priorities.

  10. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  11. Regionalism versus integration of the EU electricity market : An open debate from the comparative and prospective analysis of regulatory regimes in the central European countries

    Energy Technology Data Exchange (ETDEWEB)

    Engoian, Alda; Mouchart, Christel

    2005-12-15

    The failure of integration of 25 national energy markets into an unique one has been clearly expressed by the European Commission in its last benchmarking report. This working paper investigate the question of the more appropriate and realistic market design to limit perverse effects linked to the gaps between Western and Eastern European electricity markets. The paper consists in comparing electricity regulations per segment of the value chain in the CECs (Czech Republic, Hungary, Poland, Slovakia) characterized by industrial structures stemming from the socialism. Our regulatory approach and the example of South-East Europe support the idea of regionalism as an interim stage towards a final integrated European market. This regionalism based on the Standard Market Design concept, with flexible principles, and simultaneously combined to national reforms would seem to be a ''key of success''. (Author)

  12. Regionalism versus integration of the EU electricity market : An open debate from the comparative and prospective analysis of regulatory regimes in the central European countries

    International Nuclear Information System (INIS)

    Engoian, Alda; Mouchart, Christel

    2005-01-01

    The failure of integration of 25 national energy markets into an unique one has been clearly expressed by the European Commission in its last benchmarking report. This working paper investigate the question of the more appropriate and realistic market design to limit perverse effects linked to the gaps between Western and Eastern European electricity markets. The paper consists in comparing electricity regulations per segment of the value chain in the CECs (Czech Republic, Hungary, Poland, Slovakia) characterized by industrial structures stemming from the socialism. Our regulatory approach and the example of South-East Europe support the idea of regionalism as an interim stage towards a final integrated European market. This regionalism based on the Standard Market Design concept, with flexible principles, and simultaneously combined to national reforms would seem to be a ''key of success''. (Author)

  13. Pharma Opportunities and Risks Multiply as Regulatory Reform Remakes APAC: Expanded Accelerated Pathways Challenge Developer Value Story, Evidence Collection, and Market Access Strategies.

    Science.gov (United States)

    Grignolo, Alberto; Mingping, Zhang

    2018-01-01

    Sweeping reforms in the largest markets of the Asia-Pacific region are transforming the regulatory and commercial landscape for foreign pharmaceutical companies. Japan, South Korea, and China are leading the charge, establishing mechanisms and infrastructure that both reflect and help drive international regulatory convergence and accelerate delivery of needed, innovative products to patients. In this rapidly evolving regulatory and commercial environment, drug developers can benefit from reforms and proliferating accelerated pathway (AP) frameworks, but only with regulatory and evidence-generation strategies tailored to the region. Otherwise, they will confront significant pricing and reimbursement headwinds. Although APAC economies are at different stages of development, they share a common imperative: to balance pharmaceutical innovation with affordability. Despite the complexity of meeting these sometimes conflicting demands, companies that focus on demonstrating and delivering value for money, and that price new treatments reasonably and sustainably, can succeed both for their shareholders and the region's patient population.

  14. Dabigatran Levels in Elderly Patients with Atrial Fibrillation: First Post-Marketing Experiences.

    Science.gov (United States)

    Bolek, Tomáš; Samoš, Matej; Škorňová, Ingrid; Stančiaková, Lucia; Staško, Ján; Galajda, Peter; Kubisz, Peter; Mokáň, Marián

    2018-05-08

    The number of elderly individuals with non-valvular atrial fibrillation (NV-AF) requiring long-term anticoagulation is rising. The pharmacokinetics of oral anticoagulants in elderly individuals may differ from that for younger patients. The aim of this study was to assess the dabigatran levels in elderly patients with NV-AF. A pilot prospective post-marketing study in patients with NV-AF on dabigatran therapy was performed; we enrolled 21 consecutive elderly patients (aged ≥ 75 years) on a reduced dabigatran regimen (110 mg twice daily) and compared them with 13 younger (≤ 70 years) individuals on reduced dabigatran therapy due to renal impairment and with 16 younger patients on standard dabigatran therapy (150 mg twice daily). Blood samples were taken for the assessment of dabigatran trough and peak levels. Dabigatran levels were measured with the Hemoclot ® Thrombin Inhibitor Assay. There were significant differences in dabigatran trough levels when comparing elderly patients on reduced dabigatran with non-elderly patients on reduced dabigatran (99.3 ± 73.6 vs 51.6 ± 25.6 ng/mL; p Similarly, the detected dabigatran peak levels were significantly higher in elderly patients on reduced dabigatran compared with non-elderly patients on reduced dabigatran (173.4 ± 116.2 vs 116.1 ± 19.1 ng/mL; p similar levels compared with younger individuals on standard dabigatran.

  15. The role of the pharmaceutical animal health industry in post-marketing surveillance of resistance.

    Science.gov (United States)

    Lens, S

    1993-06-01

    The pharmaceutical animal health industry must be committed to the total life cycle of products, i.e. during both the pre- and post-marketing period. Support of antibacterial agents during the postmarketing period is not restricted to maintaining a well-established distribution and promotion system. Care has to be taken continuously to maintain and/or improve the quality, safety (for user, target animal and environment) and clinical efficacy. The pharmaceutical industry contributes to this by: 1. Introducing antibacterials in different animal species for the most effective disease condition only and by ensuring the veterinary profession is informed about relevant findings on: a. the mechanism of action; b. pharmacodynamic properties; c. pharmacokinetic properties (plasma, target tissue); d. clinical efficacy data and in vitro sensitivity data; e. valid species-specific MIC breakpoints; f. precise dose and treatment regime. 2. Updating on a regular basis on: a. new findings on the mechanism of action (in vitro and in vivo); b. the optimal use program in the light of changes in animal husbandry, farm management and epidemiology on national and international level; c. adjustment of species-specific MIC breakpoints when necessary. 3. Providing continuous information in collaboration with animal health laboratories about: a. clinical field surveillance for efficacy (national, international); b. in vitro sensitivity/resistance surveillance (national, international); c. use of in vitro data to support prediction of in vivo efficacy. Surveillance of resistance, in vitro, is therefore part of a package of information needed on a routine basis by the pharmaceutical industry to allow the best possible use of antibacterials and to minimize induction of resistance.(ABSTRACT TRUNCATED AT 250 WORDS)

  16. Marketing of breast-milk substitutes in Zambia: evaluation of compliance to the international regulatory code.

    Science.gov (United States)

    Funduluka, P; Bosomprah, S; Chilengi, R; Mugode, R H; Bwembya, P A; Mudenda, B

    2018-03-01

    We sought to assess the level of non-compliance with the International Code of Marketing breast-milk substitutes (BMS) and/or Statutory Instrument (SI) Number 48 of 2006 of the Laws of Zambia in two suburbs, Kalingalinga and Chelstone, in Zambia. This was a cross sectional survey. Shop owners (80), health workers (8) and mothers (214) were interviewed. BMS labels and advertisements (62) were observed. The primary outcome was mean non-compliance defined as the number of article violations divided by the total 'obtainable' violations. The score ranges from 0 to 1 with 0 representing no violations in all the articles and one representing violations in all the articles. A total of 62 BMS were assessed. The mean non-compliance score by manufacturers in terms of violations in labelling of BMS was 0.33 (SD = 0.28; 95% CI: 0.26, 0.40). These violations were mainly due to labels containing pictures or graphics representing an infant. 80 shops were also assessed with mean non-compliance score in respect of violations in tie-in-sales, special display, and contact with mothers at the shop estimated as 0.14 (SD = 0.14; 95% CI: 0.11, 0.18). Non-compliance with the Code and/or the local SI is high after 10 years of domesticating the Code.

  17. [Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection].

    Science.gov (United States)

    Xiao, Ying; Zhao, Yubin; Xie, Yanming

    2011-10-01

    The nested case-control study design (or the case-control in a cohort study) is described here as a new study design used in safe evaluation of post-marketing traditional Chinese medicine injection. In the nested case-control study, cases of a disease that occur in a defined cohort are identified and, for each, a specified number of matched controls is selected from among those in the cohort who have not developed the disease by the time of disease occurrence in the case. For many research questions, the nested case-control design potentially offers impressive reductions in costs and efforts of data collection and analysis compared with the full cohort approach, with relatively minor loss in statistical efficiency. The nested case-control design is particularly advantageous for studies in safe evaluation of post-marketing traditional Chinese medicine injection. Some examples of the application of nested case-control study were given.

  18. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    Energy Technology Data Exchange (ETDEWEB)

    Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

    2015-11-15

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  19. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

    Science.gov (United States)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F

    2015-11-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

  20. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    International Nuclear Information System (INIS)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

    2015-01-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  1. A post-marketing safety and efficacy assessment of a monoclonal antibody purified high-purity factor VIII concentrate.

    Science.gov (United States)

    Hay, C R; Lee, C A; Savidge, G

    1996-01-01

    The identification of infrequent side-effects of clotting factor concentrates, undetected by clinical trials, is facilitated by post-marketing surveillance. We present a post-marketing surveillance study in which 97 patients with haemophilia A, attending three haemophilia centres, were treated over a median follow-up period of 284 days (range 1-1074), and a total follow-up period of 30,080 days, with a pasteurized immunoaffinity purified factor VIII concentrate (Monoclate-P, Armour, Collegeville, USA). 5216 infusions, using 10,527,000 units of Monoclate-P, were carried out, mostly for routine haemarthroses or prophylaxis. No new inhibitors were observed during the study. At the start of the study 60/97 were HIV seropositive, 67/97 HBs antibody positive, 12 HbsAb negative and the remainder HBsAb positive before the study period. 13/14 tested were HAV seropositive at the beginning of the study. One patient became HAV seropositive during the study period, an infection thought to be community acquired. No other seroconversions were observed. Only one mild transfusion reaction was observed. This study confirms the safety and efficacy of Monoclate-P. Post-marketing surveillance or nationally organized pharmaco-vigilance should be practiced more widely to enable identification of low-frequency side-effects of treatment.

  2. Limits and opportunities of marketeering tertiary education in post-colonial Zimbabwe

    OpenAIRE

    Patrick Sibanda

    2016-01-01

    This paper intended to assess the impact of marketeering tertiary education in Zimbabwe. The paper revealed that marketeering of tertiary education in Zimbabwe has drastically impacted on access to higher education and training. Poor and vulnerable students have found it difficult to access tertiary education due to escalating commercialized fees. Literature indicates that, even in developed countries like UK, marketeering tertiary education has led to decreased enrolments, diminishing prospe...

  3. PERFORMANCE OF SELECTED PRE-HARVEST AND POST-HARVEST CORN AND SOYBEAN MARKETING STRATEGIES VS. ALTERNATIVE MARKET BENCHMARKS

    OpenAIRE

    Blue, E. Neal; Wisner, Robert N.; Baldwin, E. Dean

    2004-01-01

    This study was undertaken to update earlier work by the authors that analyzed selected preharvest pricing strategies utilizing options markets to establish a price floor for part of the crop in the spring, with additional pricing done by use of short hedges in early summer. The timing of implementing these strategies was moved back to late February if the previous year's U.S. crop was a weather-induced short crop. A weather-induced short crop as opposed to a government program induced short c...

  4. 78 FR 8666 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-02-06

    ... mechanism of a free and open market and a national market system, and, in general, to protect investors and... supports the objectives of perfecting the mechanism of a free and open market and the national market... market-wide circuit breakers pilot until the initial date of operations of the LULD Plan would allow the...

  5. 77 FR 37086 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2012-06-20

    ... size of the Market Maker Peg Order below one round lot, the market maker would need to enter a new... New Market Maker Peg Order Available to Exchange Market Makers June 14, 2012. Pursuant to Section 19(b... of the Proposed Rule Change The Exchange proposes to adopt a new Market Maker Peg Order to provide...

  6. 76 FR 62484 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-10-07

    ... Proposed Rule Change To Modify NASDAQ Options Market Rules Chapter VII, Section 6, Market Maker Quotations... NASDAQ Options Market (``NOM'') to amend Chapter VII, Section 6, Market Maker Quotations, to permit wider..., also known as quotation spread parameters, establish the maximum permissible width between a Market...

  7. Extent and content of data for regulatory submissions: First-in-human and marketing authorization--Viewpoint of US industry.

    Science.gov (United States)

    Harris, Ian Ross

    2015-09-01

    The amount and type of data in regulatory submissions increases dramatically from the first-in-human clinical trials application through to the extensive dossier that is required for marketing authorization. The Pharmaceuticals and Biotechnology industries are very familiar with the requirements and expectations of Health Authorities for small molecule and biologics, but have limited experience for cell-based therapies. Fortunately, the United States Food and Drug Administration (FDA) and European Medicines agency (EMA) Committee for Advanced Therapies (CAT) have considerable experience in regulating cell therapies and have provided extensive Guidance documents for developers. The Agencies offers advice to Sponsors through a variety of meetings. However, it is incumbent on the Sponsor to understand the regulations, interpret the Guidance documents and formulate clear company positions to enable the Agency to provide clear feedback. It is important for Sponsors to understand the factors that are critical for the safety and efficacy of their product and to demonstrate to the Health Authorities that they have a control strategy that ensures safety and efficacy during all stages of development. The focus of this paper is to describe some of the challenges for the chemistry manufacturing and controls (CMC) for cell therapies being development internationally. Copyright © 2015.

  8. Displacement in new economy labor markets: Post-displacement wage loss in high tech versus low tech cities.

    Science.gov (United States)

    Davis, Daniel J; Rubin, Beth A

    2016-11-01

    While scholars and politicians tout education as the salve to employment disruptions, we argue that the geography of the new economy, and the social closure mechanisms that geography creates, may be just as important as individuals' characteristics for predicting post-displacement wage loss (or gain). We use data from the 2012 Displaced Workers ement of the Current Population Survey and from the 2010 United States Census to test hypotheses linking local labor markets in different industrial contexts to post-displacement wage loss. Our results point to age as a closure mechanism, and to the partially protective effect of education in high-tech versus low-tech economic sectors. This study is the first to use national level data to examine how employment in high-tech cities influences post-displacement wages. These findings are relevant both for theorizing about the new economy and for public policy. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Pushed, pulled, or blocked? The elderly and the labor market in post-Soviet Russia.

    Science.gov (United States)

    Gerber, Theodore P; Radl, Jonas

    2014-05-01

    Russia provides an interesting context for studying the labor market experiences of the elderly because of its experience with market transition, its looming growth in the elderly dependency ratio, and its unusual pension policies that do not penalize pensioners for working. We use data from twenty surveys of the Russian population conducted from February 1991 to November 2007 to analyze the labor market participation and earnings of elderly Russians following market transition. Economic desperation, exacerbated by low pension levels, pushed some elderly to seek employment for income on the labor market. Elderly Russians with more education had more opportunities to work, and education differentials increased as market reforms progressed. The correlates of earnings operate similarly for retirement- and pre-retirement age Russians, with several exceptions: unobserved factors favoring employment are negatively associated with earnings for the elderly, occupation mediates most of the effects of education, and patterns of change over time differ somewhat. Elderly Russians are not disproportionately blocked from employment following market reforms. Following the initial transition shock, their labor market activity increased. Overall, both push and pull factors shape the employment and earnings of the elderly, affecting different segments of them. Copyright © 2013 Elsevier Inc. All rights reserved.

  10. Valutazione della qualitá dei dati in uno studio post marketing

    Directory of Open Access Journals (Sweden)

    D. D’Alessandro

    2003-05-01

    Full Text Available

    Obiettivo: misurare l'affidabilita nella segnalazione
    di eventi avversi a vaccino nell'ambito di uno studio post-marketing sulla tollerabilita della vaccinazione antipneumococcica (AP in associazione con la vaccinazione antinfluenzale (AI nella popolazione anziana.


    Metodi: e stato predisposto un modello di regressione
    logistica per stimare gli OR tra la segnalazione di almeno un effetto collaterale locale (y ed alcune variabili individuali dei vaccinati (x1: eta .75 anni; x2: sesso; x3: allergie; x4: associazione AI+AP; x5: vivere solo; x6: patologie croniche. I medici aderenti al progetto (229 sono stati stratificati in cinque categorie in funzione dellfincidenza media di eventi avversi da loro registrata: 0% (29, 1-5%
    (68, 6-10% (50, 11-50% (72, .50% (10. Lo stesso modello di regressione e stato applicato ai quattro
    sotto-gruppi di vaccinati afferenti alle categorie di medici che hanno segnalato sintomi, per valutare la coerenza degli OR registrati nei gruppi.

    Risultati: tra i 29.086 vaccinati, l'f11,3% (3.278 ha segnalato almeno un evento avverso locale nelle
    72 ore successive alla vaccinazione: 9,9% tra i soggetti vaccinati con AI e 13,9% tra i vaccinati con
    AI+AP. I fattori significativamente associati all'faumento di rischio sono: AI+AP (OR 1,4; allergie (OR 1,3; patologie croniche (OR 1,3. L' applicazione del modello di regressione ai sotto-gruppi di vaccinati ha mostrato un trend negli OR per le categorie di medici che hanno segnalato dall'f1-5% fino all'f11- 50%, mostrando un'effettiva differenza di rischio dei pazienti.

    Tale coerenza non si e evinta nell'ultima categoria (.50%, dove tali fattori appaiono addiritura protettivi nei riguardi dei sintomi (AI+AP: OR 0,5; allergie: OR 0,7, o non associati
    (patologie croniche: OR 1,0.

    Conclusioni: il 4,3% dei medici arruolati nello studio (10 su 229 ha

  11. [Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

    Science.gov (United States)

    Inagaki, Osamu

    2016-04-01

    Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

  12. 77 FR 35732 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-06-14

    ... important Exchange function to provide an opportunity to all market participants to trade against Customer... traded under the symbol MNX (``MNX'') as follows: Non-NOM market NOM market Customer Professional Firm... order resting on the NOM book. [[Page 35733

  13. Tendances Carbone no. 92. Carbon markets and the post-2020 Agreement

    International Nuclear Information System (INIS)

    Marcu, Andrei

    2014-06-01

    Among the publications of CDC Climat Research, 'Tendances Carbone' bulletin specifically studies the developments of the European market for CO 2 allowances. Beside some statistical figures about energy production/consumption and carbon markets, this issue specifically addresses the following points: - EU ETS reforms: on 25 June, the EU Commission will host a panel of experts to discuss technical aspects of the proposal of the Market Stability Reserve. - Market Stability Reserve of the EU ETS: Germany supports the Commission proposal of a market stability reserve and calls for a launch of the mechanism significantly before 2020, i.e. already in 2017. - 2030 energy and climate package: on 26 and 27 June, the EU Council will discuss the target of CO 2 emissions reduction of 40% by 2030 to take a final decision as soon as possible and later in October 2014

  14. Impacts of the regulatory model for market risk capital: application in a special savings company, an insurance company, and a pension fund

    Directory of Open Access Journals (Sweden)

    Betty Lilian Chan

    Full Text Available ABSTRACT In line with the regulation brought in by Solvency II, the Superintendence of Private Insurance (Susep introduced the market risk capital requirement at the end of 2015, with 50% of the minimum capital for this type of risk being required by December 31st 2016 and 100% the following year. This regulatory model consists of calculating parametric value at risk with a 99% confidence level and a three month time horizon, using the net exposure of expected cash flows from assets and liabilities and a covariance matrix updated with market data up to July 2014. One limitation of this regulatory approach is that the updating of the covariance matrix depends on prior approval by the National Council of Private Insurance, which can limit the frequency the covariance matrix is updated and the model’s adherence to the current market reality. As this matrix considers the period before the presidential election, the country’s loss of investment grade status, and the impeachment process, which all contributed to an increase in market volatility, this paper analyses the impacts of applying the regulatory model, considering the market volatility updated to December 31st 2015, for a special savings company (sociedade de capitalização, an insurance company, and an pension fund. Furthermore, the paper discusses the practical implications of the new market risk requirement for managing the investments of the entities supervised by Susep, listing the various assumptions that can be used in the regulated entities’ Asset and Liability Management decision models and possible trade-offs to be addressed in this process.

  15. Federal Market Information Technology in the Post Flash Crash Era: Roles for Supercomputing

    Energy Technology Data Exchange (ETDEWEB)

    Bethel, E. Wes; Leinweber, David; Ruebel, Oliver; Wu, Kesheng

    2011-09-16

    This paper describes collaborative work between active traders, regulators, economists, and supercomputing researchers to replicate and extend investigations of the Flash Crash and other market anomalies in a National Laboratory HPC environment. Our work suggests that supercomputing tools and methods will be valuable to market regulators in achieving the goal of market safety, stability, and security. Research results using high frequency data and analytics are described, and directions for future development are discussed. Currently the key mechanism for preventing catastrophic market action are “circuit breakers.” We believe a more graduated approach, similar to the “yellow light” approach in motorsports to slow down traffic, might be a better way to achieve the same goal. To enable this objective, we study a number of indicators that could foresee hazards in market conditions and explore options to confirm such predictions. Our tests confirm that Volume Synchronized Probability of Informed Trading (VPIN) and a version of volume Herfindahl-Hirschman Index (HHI) for measuring market fragmentation can indeed give strong signals ahead of the Flash Crash event on May 6 2010. This is a preliminary step toward a full-fledged early-warning system for unusual market conditions.

  16. Marketing.

    Science.gov (United States)

    Chambers, David W

    2010-01-01

    There is not enough marketing of dentistry; but there certainly is too much selling of poor quality service that is being passed off as dentistry. The marketing concept makes the patient and the patients' needs the ultimate criteria of marketing efforts. Myths and good practices for effective marketing that will promote oral health are described under the traditional four "Ps" categories of "product" (best dental care), "place" (availability), "promotion" (advertising and other forms of making patients aware of available services and how to use them), and "price" (the total cost to patients of receiving care).

  17. Evidence-based review of seeding in post-fire rehabilitation and native plant market feasibility

    Science.gov (United States)

    Donna L. Peppin

    2009-01-01

    A changing climate and fire regime shifts in the western United States have led to an increase in revegetation activities, in particular post-wildfire rehabilitation and the need for locally-adapted plant materials. Broadcast seeding is one of the most widely used post-wildfire emergency response treatments to minimize soil erosion, promote plant community recovery,...

  18. Forms and Factors of Animal Products Marketing in the early post-Meiji Years

    OpenAIRE

    Ono, Seishi

    1982-01-01

    As far as the period after the Meiji era is concerned, at its begining marketing of animal products was formed in conlpliance with the properties of products as a public commodity and the amount of investment needed. The former factor depends basically on the divisibility and the preservation possibilities of the products. The latter is the capital needed for marketing and production. 1) Eggs are the most divisible and preservable of all the animal products. Also, hens can be kept with sm...

  19. 76 FR 27134 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-05-10

    ... introduce a new order type to assist Market Makers with their market making requirements under NOM rules... to Market Makers a two-sided alternative, rather than having to enter two separate orders each with a... executed, the side that is unexecuted is canceled and returned to the entering Market Maker. Similarly, the...

  20. 78 FR 23611 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-04-19

    ... computerized methodology. As originally adopted, if a member enters Designated Retail Orders through a market... Active in the NASDAQ Market Center and the NASDAQ Options Market In March 2013,\\10\\ NASDAQ adopted a new... Market Center and NOM, the criteria for these new tiers, as well as the new tier for Designated Retail...

  1. 75 FR 59311 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule...

    Science.gov (United States)

    2010-09-27

    ... cancelled, the Market Maker shall enter new bid interest at a price not more than the Designated Percentage... Market Maker shall enter new offer interest at a price not more than the Designated Percentage away from... market makers to engage in passive market making or to enter stabilizing bids pursuant to Nasdaq Rules...

  2. 75 FR 29371 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule...

    Science.gov (United States)

    2010-05-25

    ... fees that will provide subscribers with market information and increased market transparency that will...-dealers increased authority and flexibility to offer new and unique market data to the public. It was... listings, trades, and market data itself, providing virtually limitless opportunities for entrepreneurs who...

  3. Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report.

    Science.gov (United States)

    Johanson, Chris-Ellyn; Balster, Robert L; Henningfield, Jack E; Schuster, Charles R; Anthony, James C; Barthwell, Andrea G; Coleman, John J; Dart, Richard C; Gorodetzky, Charles W; O'Keeffe, Charles; Sellers, Edward M; Vocci, Frank; Walsh, Sharon L

    2009-12-01

    The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and 11 recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized.

  4. Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data

    International Nuclear Information System (INIS)

    Zhu, Xiao; Kruhlak, Naomi L.

    2014-01-01

    Graphical abstract: - Abstract: Drug-induced liver injury (DILI) is one of the most common drug-induced adverse events (AEs) leading to life-threatening conditions such as acute liver failure. It has also been recognized as the single most common cause of safety-related post-market withdrawals or warnings. Efforts to develop new predictive methods to assess the likelihood of a drug being a hepatotoxicant have been challenging due to the complexity and idiosyncrasy of clinical manifestations of DILI. The FDA adverse event reporting system (AERS) contains post-market data that depict the morbidity of AEs. Here, we developed a scalable approach to construct a hepatotoxicity database using post-market data for the purpose of quantitative structure–activity relationship (QSAR) modeling. A set of 2029 unique and modelable drug entities with 13,555 drug-AE combinations was extracted from the AERS database using 37 hepatotoxicity-related query preferred terms (PTs). In order to determine the optimal classification scheme to partition positive from negative drugs, a manually-curated DILI calibration set composed of 105 negatives and 177 positives was developed based on the published literature. The final classification scheme combines hepatotoxicity-related PT data with supporting information that optimize the predictive performance across the calibration set. Data for other toxicological endpoints related to liver injury such as liver enzyme abnormalities, cholestasis, and bile duct disorders, were also extracted and classified. Collectively, these datasets can be used to generate a battery of QSAR models that assess a drug's potential to cause DILI

  5. Linking Entrepreneurial Orientation to Firm Performance in a Post-Socialist Market Context: the Case of Hungary

    Directory of Open Access Journals (Sweden)

    David KOVACS

    2016-12-01

    Full Text Available Entrepreneurial orientation provoked the interest of numerous scholars as well as political and administrative decision-makers. Both start-ups and already established corporate entities are increasingly persecuting new opportunities, products, and business models in order to establish superiority above their competitive environment. The tendencies evince an optimist impact of entrepreneurial orientation on business performance, namely on financial performance. Beyond the aforementioned relationship, there are impulses such as environmental and organizational factors, which are affecting the businesses. The results of this study provide evidence of the effect of entrepreneurial orientation on business performance in a post-socialist context. We test the impact of three moderators on this bivariate relationship. In contrast to the substantial body of literature for Western markets, we contribute to minimizing the considerable gap of research in post-socialist economies. Entrepreneurial orientation as an organizational behavior may affect the financial performance of businesses differently in distinct market contexts. Both, internal and external factors are crucial to identifying, analyze and monitor, to achieve superior performance and to overcome competitors. This study builds upon a stratified sampling survey of Hungarian company owners and managers from the Amadeus database. The study uses a deductive approach. For the analysis, we rely on structural equation modeling using the PLS algorithm. Our study contributes to the existing literature by means of confirming the entrepreneurial orientation to firm performance relationship for Hungary. In this context, we test the moderating effects of environmental dynamism, environmental hostility as environmental factors and firm age as an organizational factor. Environmental hostility is closely related to an unfavorable environment, deriving from rapid and radical changes in the industry, which are

  6. Post-market drug evaluation research training capacity in Canada: an environmental scan of Canadian educational institutions.

    Science.gov (United States)

    Wiens, Matthew O; Soon, Judith A; MacLeod, Stuart M; Sharma, Sunaina; Patel, Anik

    2014-01-01

    Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.

  7. Integration of Financial Markets in Post Global Financial Crises and Implications for British Financial Sector: Analysis Based on A Panel VAR Model

    OpenAIRE

    Nasir, M; Du, M

    2017-01-01

    This study analyses the dynamics of integration among global financial markets in the context of Global Financial Crisis (2008) by employing a Panel Vector Autoregressive (VAR) model on the monthly data of nine countries and three markets from Jan 2003 to Oct 2015. It was found that there has been a shift in the association among the global financial markets since Global Financial Crisis (GFC).Moreover, the British financial sectors in Post-GFC world clearly showed a change in the association...

  8. A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records

    Directory of Open Access Journals (Sweden)

    Yamamoto K

    2011-04-01

    Full Text Available Keiichi Yamamoto1, Shigemi Matsumoto2, Kazuhiro Yanagihara2, Satoshi Teramukai1, Masanori Fukushima1,2,31Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan; 2Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan; 3Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, JapanPurpose: In conventional clinical studies, the cost of data management for the purposes of quality control tend to be high and collecting paper-based case report forms (CRFs can be burdensome, because paper-based CRFs must be developed and filled out for each clinical study protocol. Use of electronic health records (EHRs for this purpose could reduce costs and improve data quality in clinical studies. Kyoto University Hospital launched an EHR system in January 2005. At the same time, a replicate of that database was established for other purposes. At the Outpatient Oncology Unit of Kyoto University Hospital we developed a data-capture system that includes a cancer clinical database system and a data warehouse for outcomes studies. This system allows us to accumulate data at low cost and apply it to various uses in clinical or outcomes studies. Here we report on the application of this system to the post-marketing surveillance of drugs.Methods: We evaluated the availability of this system and identified problems for future development. With this system investigators can register cases for post-marketing surveillance, and the registered cases are listed on a screen. When CRFs for a particular case are required, data can be extracted from the list and CRFs are produced in PDF format.Results and conclusion: In this study we confirmed the applicability of our new system to post-marketing surveillance in providing prompt and efficient data exchange. We expect it to reduce the cost of data management and analysis and to improve the quality of data in post-marketing

  9. [Taking evaluation of post-marketing as point of cut-in to promote systematic research of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Yong-yan; Wang, Zhi-fei; Xie, Yan-ming

    2014-09-01

    Research on post-marketing Chinese medicine should be the systematic study from application to mechanism. Clinical evaluation is the basis of mechanism study, we can find the clue from clinical evaluation, then make a mechanism study to find the reason, then apply the results to clinic. So it is a virtuous circle. In order to achieve it, we cannot be limited to traditional Chinese medicine, we should form multi-disciplinary team under the direction of grand science thinking, try hard to put industry-university-research institute collaboration association to use, and if necessary, explore the new model of the whole nation system. An appropriate operation mechanism is very important.

  10. The Spanish Gas Market: Demand Trends Post Recession and Consequences for the Industry

    OpenAIRE

    2011-01-01

    In parallel with a flourishing economy, the natural gas industry in Spain was characterised by rapid consumption growth in the late 1990s and 2000s. Infrastructure and supplies were designed to meet the needs of a gas market growing at double digit rates each year. This high growth rate – for a European gas market – was expected to continue until at least the mid-2010s. By 2011, this outlook was replaced by a more pessimistic one. Firstly, the country’s economy was hit hard by the global rece...

  11. Effects of Intensifying Labor Market Programs on Post-Unemployment Wages: Evidence From a Controlled Experiment

    DEFF Research Database (Denmark)

    Sørensen, Kenneth Lykke

    This paper investigates effects on wages of a Danish field experiment intensifying Active Labor Market Policies (ALMP).We link unemployed workers who participated in an ALMP experiment called “Quickly Back” carried out by the Danish Ministry of Employment 2005-2006 in two counties to matched...... employer-employee and public transfer register data up to 2008 enabling us to analyze exact labor market transitions and jobs of the participants. Men in one of the counties experienced significant higher probability of earning higher short and long term wages after treatment. Treated men in the other...

  12. The POST trial: initial post-market experience of the Penumbra system: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe.

    Science.gov (United States)

    Tarr, Robert; Hsu, Dan; Kulcsar, Zsolt; Bonvin, Christophe; Rufenacht, Daniel; Alfke, Karsten; Stingele, Robert; Jansen, Olav; Frei, Donald; Bellon, Richard; Madison, Michael; Struffert, Tobias; Dorfler, Arnd; Grunwald, Iris Q; Reith, Wolfgang; Haass, Anton

    2010-12-01

    The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application. A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial. A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not. Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.

  13. 76 FR 18589 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2011-04-04

    ... on March 31, 2008 Nasdaq has monitored the operation of the market to identify instances where market.... The tiebreakers are criteria that operate in a hierarchy. If one and only one price satisfies the...

  14. Post-marketing surveillance of chemicals: organisations and databases : Workshop report

    NARCIS (Netherlands)

    Bouwmeester M; van Drongelen A; Graven C; Hernandez L; Herremans J; de Kaste D; Razenberg L; Vandebriel R; Piersma A; VTS; GZB

    2018-01-01

    The safety evaluation of chemicals is in general performed by the government, importer or manufacturer before marketing, and is based on (inter)national legislation. Less is known about the exact products in which chemicals are processed. Even though multiple institutions in the Netherlands are

  15. Post-School-Age Training among Women: Training Methods and Labor Market Outcomes at Older Ages.

    Science.gov (United States)

    Hill, Elizabeth T.

    2001-01-01

    Uses the NLS Mature Women's Cohort to examine Labor Market effects of education and training at preretirement age. Younger, more educated women tend to train more than older women. On-the-job training is more strongly associated with wage growth than is formal education. (Contains 18 references.) (MLH)

  16. Dynamic Gender Differences in a Post-Socialist Labor Market: Russia, 1991-1997

    Science.gov (United States)

    Gerber, Theodore P.; Mayorova, Olga

    2006-01-01

    We examine how the shift from state socialism affects gender inequality in the labor market using multivariate models of employment exit, employment entry, job mobility and new job quality for 3,580 Russian adults from 1991 through 1997. Gender differences changed in a complex fashion. Relative to men, women gained greater access to employment,…

  17. Young people and the post-recession labour market in the context of Europe 2020

    NARCIS (Netherlands)

    Chung, H.; Bekker, S.; Houwing, H.

    2012-01-01

    This article examines how the recent global recession, together with the general flexibilization of labour markets, is affecting young people. We examine different forms of social exclusion, including unemployment, temporary employment contracts and periods of inactivity, as well as the subjective

  18. 77 FR 63368 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-10-16

    ... not apply to non-displayed trading interest. Midpoint Peg Post-Only Orders that post to the book and... Peg Post-Only Order has expressed its intention not to execute against posted liquidity, and therefore... book until it is removed by another order, cancelled by the user or its Time-in-Force expires. To...

  19. 77 FR 38347 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2012-06-27

    ... Component, respectively, the previous trading day's closing market price for the Target Component or Benchmark Component, respectively, would be subtracted from today's closing market price for the Target... divided by the previous trading day's closing market price for the Target Component or Benchmark Component...

  20. 77 FR 69519 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-11-19

    ... Through the Introduction of New Market Quality Incentive Programs on a Pilot Basis November 9, 2012... its fees for order entry ports through the introduction of new market quality incentive programs on a... established the NBBO; and Was entered through a market participant identifier (``MPID'') that qualified for...

  1. 76 FR 64158 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-10-17

    ... stamp and message type field for reference. NASDAQ has continued to enhance the Feed to increase market... (``BDs'') increased authority and flexibility to offer new and unique market data to the public. It was..., trades, and market data itself, providing virtually limitless opportunities for entrepreneurs who wish to...

  2. 76 FR 51114 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-08-17

    ... reverse repurchase agreements (the ``Financial Instruments''), and money market instruments, including, but not limited to, U.S. government securities and repurchase agreements (the ``Money Market... securities and/or Financial Instruments and Money Market Instruments, or (ii) represent commodity pool...

  3. An Ethical Justification for Expanding the Notion of Effectiveness in Vaccine Post-Market Monitoring: Insights from the HPV Vaccine in Canada.

    Science.gov (United States)

    Komparic, Ana; Smith, Maxwell J; Thompson, Alison

    2016-04-01

    Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public's health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to be expanded in two ways to reflect a 'public health notion of post-market effectiveness', which incorporates normative public health considerations: (i) effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and (ii) the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize (and minimize) a vaccine's effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense.

  4. A conserved RNA structural element within the hepatitis B virus post-transcriptional regulatory element enhance nuclear export of intronless transcripts and repress the splicing mechanism.

    Science.gov (United States)

    Visootsat, Akasit; Payungporn, Sunchai; T-Thienprasert, Nattanan P

    2015-12-01

    Hepatitis B virus (HBV) infection is a primary cause of hepatocellular carcinoma and liver cirrhosis worldwide. To develop novel antiviral drugs, a better understanding of HBV gene expression regulation is vital. One important aspect is to understand how HBV hijacks the cellular machinery to export unspliced RNA from the nucleus. The HBV post-transcriptional regulatory element (HBV PRE) has been proposed to be the HBV RNA nuclear export element. However, the function remains controversial, and the core element is unclear. This study, therefore, aimed to identify functional regulatory elements within the HBV PRE and investigate their functions. Using bioinformatics programs based on sequence conservation and conserved RNA secondary structures, three regulatory elements were predicted, namely PRE 1151-1410, PRE 1520-1620 and PRE 1650-1684. PRE 1151-1410 significantly increased intronless and unspliced luciferase activity in both HepG2 and COS-7 cells. Likewise, PRE 1151-1410 significantly elevated intronless and unspliced HBV surface transcripts in liver cancer cells. Moreover, motif analysis predicted that PRE 1151-1410 contains several regulatory motifs. This study reported the roles of PRE 1151-1410 in intronless transcript nuclear export and the splicing mechanism. Additionally, these results provide knowledge in the field of HBV RNA regulation. Moreover, PRE 1151-1410 may be used to enhance the expression of other mRNAs in intronless reporter plasmids.

  5. Returns to the market: valuing human capital in the post-transition Czech and Slovak Republics

    Czech Academy of Sciences Publication Activity Database

    Filer, R.; Jurajda, Štěpán; Plánovský, J.

    -, č. 125 (1999), s. 1-26 ISSN 1211-3298 Institutional research plan: CEZ:AV0Z7085904 Keywords : human capital * post-transition Czech and Slovak Republics Subject RIV: AH - Economics http://www.cerge-ei.cz/pdf/wp/Wp125.pdf

  6. Collateral damage: Educational attainment and labor market outcomes among German war and post-war cohorts

    OpenAIRE

    Hendrik Jürges

    2012-01-01

    We use data from the West German 1970 census to explore the link between being born during or shortly after World War II and educational and labor market outcomes 25 years later. We document, for the first time, that men and women born in the relatively short period between November 1945 and May 1946 have significantly and substantially lower educational attainment and occupational status than cohorts born shortly before or after. Several alternative explanations for this new finding are put ...

  7. TRENDS IN THE UKRAINIAN LOAN MARKET IN THE POST-CRISIS PERIOD

    Directory of Open Access Journals (Sweden)

    Tetiana Kubakh

    2015-11-01

    Full Text Available The purpose of the paper is to systematize the data of the credit market of Ukraine in the period of economic and political turmoil and the beginning of military confrontation with Russia. The method of extended studies allows to trace the changes that have occurred not only in the banking system, but also in the whole of the economy. Methodology. The study is based on a comparison of data on a number of indicators that were taken as a basis and allow to fully analyze the credit market as a component of the capital market in the period from 2000 to 2013. Results of the survey allowed to clearly identify the problems that impede the stable development of the banking system of Ukraine, among which are the following: high cost of banking products, the marriage of skilled personnel and lack of confidence in banks, low level of culture of users of financial products, low income, high yield deposit operations increases the cost of credit products, slowing of economic development, lack of reforms, social and political tensions, armed conflict with a neighboring state. Practical implications. A clear definition of the problems in the credit market as a component of the banking system helped identify a number of areas that allow us to solve the situation. Among them, first of all, we should highlight the following: the bank regulator (the National Bank of Ukraine, must take a great responsibility as the authority of last resort in the refinancing of a bank, on a continuous basis to implement the stress testing of banks in Ukraine, to stabilize inflation and return confidence in the national currency, to set up a mechanism of mortgage lending by state banks. Value/originality. The data was obtained as a result of thorough calculations possible not only to identify problems but also to identify their solutions that will enable the Ukrainian banking system to reach a new stage in its development, and the credit market to make an essential source of economic

  8. Results of a customer-based, post-market surveillance survey of the HeRO access device.

    Science.gov (United States)

    Fusselman, Maureen

    2010-08-01

    In order to supplement post-market surveillance data on the HeRO vascular access device, a non-scientific customer survey was conducted to obtain quantitative data from dialysis providers caring for patients implanted with the device. Dialysis nurses involved in the care of HeRO patients were contacted in order to obtain post-implant device performance information for 10% of patients implanted with the device at the time of the survey. Thirty-eight dialysis units with a total of 65 HeRO patients participated in the survey. The total duration of HeRO device use was 348.4 months with an average use of 5.4 months. Thirty-eight of the 65 HeRO patients (58.5%) were reported to not have experienced any performance issues. There were 28 device performance incidents reported for the remaining 27 patients included in the survey. Occlusion was the single most commonly reported device-related performance issue with 18 patients (27.7%) experiencing 25 occlusive episodes. The majority of the patients who had an occlusion (66.7%) only experienced one occlusive event. Infections occurred in 4 patients (6.2%) with an overall infection rate of 0.38 per 1,000 patient days. Post-market clinical experience during the first 18 months of commercialization of the HeRO device were in line with expectations based on the results from initial clinical studies with the device. Device occlusion remains the most commonly reported performance issue with the reported rate in this survey less than that which was reported in earlier published studies with the device.

  9. 75 FR 51859 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-08-23

    ... acceptable execution quantity. All RPC orders must be available for automatic execution. (b) Processing of... session, the cross shall execute at the lock price. (8) If trading in a security is halted for regulatory...

  10. 76 FR 49809 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-08-11

    ... proprietary traders. The Series 56 examination program is shared by NASDAQ and the following self-regulatory..., experience and competence for members and their associated persons, in particular, by offering a new...

  11. Beyond post-marketing research and MedWatch: Long-term studies of drug risks.

    Science.gov (United States)

    Resnik, David B

    2007-10-01

    Critics of the drug safety system have discussed many different potential reforms, ranging from mandatory registration of clinical trials to increasing the power of regulatory agencies, but few have discussed one of the most important ways of enhancing safety: increasing the number of long-term studies of medications. Long-term studies of the risks and benefits of drugs can provide useful information for regulators, healthcare professionals, and patients. Government funding agencies should lead the effort to conduct long-term studies of drugs, but private companies should also be required to lend financial support. Because cost-effectiveness is likely to be an important consideration in conducting this research, funding agencies should focus, at first, on drugs that are used to treat common, chronic conditions.

  12. Post-purchase cognitive dissonance:Evidence from the mobile phone market

    OpenAIRE

    Graff, Jens; Sophonthummapharn, Kittipong; Parida, Vinit

    2012-01-01

    This article investigates whether cognitive dissonance exists in the post-purchase phase in the mobile phone industry. It asks if mobile phone users are fully satisfied since they are usually overloaded with information during the purchasing period. Three dimensions of dissonance were measured in 283 university students. The results provide interesting insights. The major differences between the high and low dissonance groups are being influenced by other people’s opinions, difficulty in find...

  13. Post-hit dynamics of price limit hits in the Chinese stock markets

    Science.gov (United States)

    Wu, Ting; Wang, Yue; Li, Ming-Xia

    2017-01-01

    Price limit trading rules are useful to cool off traders short-term trading mania on individual stocks. The price dynamics approaching the limit boards are known as the magnet effect. However, the price dynamics after opening price limit hits are not well investigated. Here, we provide a detailed analysis on the price dynamics after the hits of up-limit or down-limit is open based on all A-share stocks traded in the Chinese stock markets. A "W" shape is found in the expected return, which reveals high probability of a continuous price limit hit on the following day. We also find that price dynamics after opening limit hits are dependent on the market trends. The time span of continuously hitting the price limit is found to an influence factor of the expected profit after the limit hit is open. Our analysis provides a better understanding of the price dynamics around the limit boards and contributes potential practical values for investors.

  14. 75 FR 39315 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Order Granting...

    Science.gov (United States)

    2010-07-08

    ... this authority would expand the amount of data available to consumers, and also spur innovation and... market entry is rapid, inexpensive, and profitable. The history of electronic trading is replete with... market data vendors already have the capability to aggregate data and disseminate it on a profitable...

  15. 75 FR 47871 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule...

    Science.gov (United States)

    2010-08-09

    ... fierce competition for the inputs necessary to the creation of proprietary data and strict pricing..., trades, and market data itself, providing virtually limitless opportunities for entrepreneurs who wish to... and exploit this competition by sending their order flow and transaction reports to multiple markets...

  16. 78 FR 76179 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-12-16

    ... the past few months, however, Nasdaq has received feedback from listed companies and others that the... to and perfect the mechanism of a free and open market and a national market system, and, in general... potential competitive advantage for the other exchanges and thereby enhances competition among exchanges...

  17. 78 FR 6386 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-01-30

    ... routing orders to away markets plus the away market's transaction fee. With respect to the fixed costs... clearing and transaction charges incurred by the Exchange as well as certain other costs incurred by the... is reasonable to recoup these costs borne by the Exchange on each transaction. \\15\\ CBOE recently...

  18. 77 FR 5085 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-02-01

    ... listed on the Nasdaq Capital Market or the Nasdaq Global Market may request from Nasdaq a written... modify the fee in connection with such a request. Today, a company is required to submit a non-refundable... Reference Room, 100 F Street, NE., Washington, DC 20549, on official business days between the hours of 10 a...

  19. 78 FR 18393 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Order Granting Approval of a Proposed...

    Science.gov (United States)

    2013-03-26

    ... Financial and Quantitative Analysis, Vol. 44, 1427-1457 (2009) (``Weaver Study''); H. Bessembinder, J. Hao.... Venkataraman & A. Waisburd, ``The Value of the Designated Market Maker'' Journal of Financial and Quantitative... Value of the Specialist: Empirical Evidence from the CBOE'' Journal of Financial Markets, Vol. 9, no. 2...

  20. 78 FR 40223 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-07-03

    ... Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors... executions for the closing cross trade in any and all affected securities on a security- by-security basis... and open market and a national market system and, in general, to protect investors and the public...

  1. 77 FR 21607 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-04-10

    ... Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify NASDAQ's Transaction Execution Fee and Credit Schedule April 5, 2012. Pursuant to Section... hereby given that on March 23, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed...

  2. 78 FR 19791 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-04-02

    ... costs related to routing orders to away markets plus the away market's transaction fee. The Exchange... a fixed cost of $0.11 per contract plus a flat rate of $0.85 per contract, except with respect to... Change NASDAQ proposes to amend Chapter XV, entitled ``Options Pricing,'' at Section 2 governing pricing...

  3. 78 FR 13928 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-03-01

    ... assessing certain Exchange costs related to routing orders to away markets plus the away market's... proposes to amend its non-Customer C2 Routing Fees to assess the fixed cost of $0.11 per contract plus a... the pricing structure is reasonable because, although not an approximation of the cost of routing to...

  4. 75 FR 64375 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-10-19

    ... enable them to attract ``eyeballs'' that contribute to their advertising revenue. Retail broker-dealers... that an automobile manufacturer can charge for car sound systems despite the existence of a highly competitive market for cars and the availability of after-market alternatives to the manufacturer-supplied...

  5. 77 FR 38871 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-06-29

    ... strictly regulating the price that an automobile manufacturer can charge for car sound systems despite the existence of a highly competitive market for cars and the availability of after-market alternatives to the... attract ``eyeballs'' that contribute to their advertising revenue. Retail broker-dealers, such as Schwab...

  6. 76 FR 47621 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-08-05

    ... strictly regulating the price that an automobile manufacturer can charge for car sound systems despite the existence of a highly competitive market for cars and the availability of after-market alternatives to the... enable them to attract ``eyeballs'' that contribute to their advertising revenue. Retail broker-dealers...

  7. 76 FR 2164 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-01-12

    ... enable them to attract ``eyeballs'' that contribute to their advertising revenue. Retail broker-dealers... that an automobile manufacturer can charge for car sound systems despite the existence of a highly competitive market for cars and the availability of after-market alternatives to the manufacturer-supplied...

  8. 77 FR 39752 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-07-05

    ... strictly regulating the price that an automobile manufacturer can charge for car sound systems despite the existence of a highly competitive market for cars and the availability of after-market alternatives to the... data that will enable them to attract ``eyeballs'' that contribute to their advertising revenue. Retail...

  9. 76 FR 20054 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-04-11

    ... advertising revenue. Retail broker-dealers, such as Schwab and Fidelity, offer their customers proprietary... strictly regulating the price that an automobile manufacturer can charge for car sound systems despite the existence of a highly competitive market for cars and the availability of after-market alternatives to the...

  10. The French market of wind energy and its perspectives. Which evolution for the competition landscape in a disrupting regulatory context?

    International Nuclear Information System (INIS)

    2010-11-01

    This article presents the content of a market study which aimed at providing an overview of the development of wind energy in France after market lift-off, at assessing the influence of Grenelle II on this sector, at assessing the competitiveness of wind energy with respect to other production sources, and at analysing strategies of equipment manufacturers and operators on a market where competitive positions are from being fixed. The report proposes an overview of the French wind energy market (legal context, growth dynamics, market valorisation, cost structure and profitability, support measures), analyses the positions and challenges of wind turbine manufacturers (the front end of the sector) and of wind farm developers and operators (the back end of the sector). Several manufacturers (Areva, Enercon, Gamesa, GE Energy, Nordex, REpower, Siemens and Vestas) and developers and operators (Boralex, EDF Energies Nouvelles, EDP Renovavels, Eolfi, GDF Suez, Iberdrola Renovables, Poweo, Theolia) have been analysed

  11. Post-marketing surveillance of levofloxacin 0.5% ophthalmic solution for external ocular infections.

    Science.gov (United States)

    Kanda, Yoshiko; Kayama, Tomoko; Okamoto, Shinji; Hashimoto, Masako; Ishida, Chiemi; Yanai, Tomoko; Fukumoto, Mitsuru; Kunihiro, Eiichi

    2012-12-01

    Levofloxacin 0.5% ophthalmic solution is an antibacterial formulation, which was approved and marketed for the treatment of ocular infections in Japan in 2000. This study was designed to investigate the safety and efficacy of levofloxacin 0.5% ophthalmic solution in patients who received treatment for external ocular bacterial infections in regular clinical practice. Patients were recruited from more than 800 medical facilities in Japan, in accordance with Japanese Ministry of Health, Labour and Welfare ordinance guidelines. They were followed during three distinct time periods: April 2000 to December 2001, January 2002 to June 2003, and July 2003 to December 2004. Information from 6760 patients receiving levofloxacin for the treatment of a variety of ocular infections was collected. Levofloxacin was well tolerated: adverse drug reactions (ADRs) were reported in 42 of 6686 patients (0.63%), with no serious ADRs reported. The most commonly reported ADRs were ocular disorders such as blepharitis, eye irritation, and punctate keratitis. The incidence of ADRs did not differ significantly with age, but it was significantly higher in females (0.82%) than in males (0.36%; p = 0.028). A clinical response was observed in 95.5% of patients receiving levofloxacin, with no difference in response between the three time periods. The rate of response to levofloxacin by bacterial disease ranged from 97.4% in keratitis to 88.3% in dacryocystitis. The rate was lower in patients with dacryocystitis, elderly patients, patients with a long duration of illness, and relapsing cases (all p marketing surveillance of levofloxacin, conducted over 4 years, confirms the safety and efficacy of levofloxacin in regular clinical use and highlights that levofloxacin is a promising treatment for a variety of external ocular bacterial infections.

  12. 78 FR 69468 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and...

    Science.gov (United States)

    2013-11-19

    ... provide that in situations of a regulatory halt, trading pause or market-wide trading halt, a Post-Halt... situation of a halt pursuant to Rule 504(a), just as today, the Post-Halt Notification will continue to be..., Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. All submissions should refer...

  13. Secrets, Trauma, and the Memory Market (or the return of the repressed in recent Argentine post-dictatorship cultural production

    Directory of Open Access Journals (Sweden)

    Silvia R Tandeciarz

    2012-04-01

    Full Text Available Since the end of the last Argentine Dictatorship (1976-1983, a number of feature-length films have engaged in the public debate over the legacies of state terrorism. El secreto de sus ojos (2009, Argentina's most recent Oscar winner, is the latest to do so, exploring the effects of more than a decade of impunity on those who lost their loved ones. Suggesting that restoration of a justice system that works can lead to the restoration of full civic engagement in a healthy body politic, the film raises important questions about citizenship and belonging in a post-national era. This essay explores the film's phenomenal success in the global memory market to illuminate what remains at stake in contemporary narratives of reconciliation.

  14. Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

    Science.gov (United States)

    Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

    2017-08-01

    Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

  15. From Reciprocal Social Networks to Action Groups for Market Exchange: “Spontaneous Privatization” in Post-Communist Hungary

    Directory of Open Access Journals (Sweden)

    Larissa Lomnitz

    2011-12-01

    Full Text Available Following previous research on the significance that social networks have had for the economic and social survival of Latin American and Soviet state-employed middle classes, this paper explores the role of social networks (connections on the process of privatization and market liberalization of Post-Communist Hungary. Based on former academic studies and on field research conducted for several months in Budapest, we will try to show that social networks are central intermediary structures on which individuals and groups construct solutions that allow them to cope with the deficiencies resulting from the formal system. From this perspective we will explore the importance of manager’s connections in the first period of the Hungarian privatization process known as “spontaneous privatization”.

  16. The development of market power in the Spanish power generation sector: Perspectives after market liberalization

    International Nuclear Information System (INIS)

    Ciarreta, Aitor; Nasirov, Shahriyar; Silva, Carlos

    2016-01-01

    This paper provides a comprehensive analysis of the market power problem in the Spanish power generation sector and examines how and to which extent the market has developed in terms of market power concerns after the market liberalization reforms. The methodology applied in this study includes typical ex-post structural and behavioral measures employed to estimate potential for market power, namely: concentration ratios (CR) (for the largest and the three largest suppliers), the Herfindahl–Hirschman Index (HHI), Entropy, Pivotal Supply Index, the Residual Supply Index and Residual Demand Elasticity (RDE). The results are presented for the two largest Spanish generating companies (Endesa and Iberdrola) acting in the Iberian Electricity Market (MIBEL), and in the Spanish Day-ahead electricity market. The results show evidence that these companies have behaved much more competitively in recent periods than in the beginning of the market liberalization. In addition, the paper discusses important structural and regulatory changes through market liberalization processes in the Spanish Day-ahead electricity market. - Highlights: •Competition and regulation in the Spanish electricity market. •The methodology applied in this study: ex-post structural and behavioral measures. •Key dominant companies behaved more competitively in recent periods. •Important structural and regulatory changes in the Spanish electricity market.

  17. The economics of renewable electricity market integration. An empirical and model-based analysis of regulatory frameworks and their impacts on the power market

    Energy Technology Data Exchange (ETDEWEB)

    Nicolosi, Marco

    2012-07-01

    As power systems increase in complexity due to higher shares of intermitting RES-E, so increase the requirements for power system modeling. This thesis shows empirically, with examples from Germany and Texas, that the increasing RES-E share strongly affects current power market operation. The markets further create price signals, which lead to system adaptations in the long-run. To get an estimate of the adaptation effects, 'The High Temporal Resolution Electricity Market Analysis Model' (THEA) has been developed. In a first application for the ERCOT market in Texas, particular model attributes are tested and compared to some complexity reducing approaches, i.e. the reduction of temporal resolution and the reduction of operational constraints. In both cases, the results show significant differences compared to the results when the full spectrum of THEA's capabilities is utilized. The ERCOT case study additionally shows that the adaptation to RES-E in an isolated, mainly thermal-based power system is quite severe. Market signals which underline this conclusion are the severely reduced value of wind energy, the increasing curtailment and the strong shift towards peak-oriented generating capacities. The second application of THEA models the German power market with its interconnected markets. This analysis increases the complexity significantly by modeling a well interconnected system, increasing the amount of different RES-E technologies and adding CAES investment options. In order to assess the impact on the different system component's supply, demand and grid infrastructure, specific measures are applied to compare several scenarios. Each scenario represents a policy option, which either reduces or increases the flexibility of the power system. The scenario comparisons capture the effects of a lower RES-E share, a larger baseload capacity fleet, higher interconnector capacities, various RES-E support scheme designs and the capability of RES-E to

  18. Environmental challenges and opportunities of the evolving North American electricity market : European electricity generating facilities: an overview of European regulatory requirements and standardization efforts

    International Nuclear Information System (INIS)

    Nichols, L.

    2002-06-01

    Several factors are affecting power generating facilities, such as the opening of both electricity and gas markets, and the pressure applied on generators and governments to ensure a steady energy supply for consumers. An additional factor is the pressure for the closing of nuclear power facilities. European siting and emissions requirements for coal-fired and natural gas generating facilities were presented in this background paper. In addition, the author provided an overview of the standardization process in place in Europe. The European Union and its functioning were briefly described, as well as a listing of relevant organizations. The current trends were examined. The document first introduced the European Union, and the next section dealt with Regulatory regime: the internal energy market. The third section examined the issue of Regulatory regime: generation and environmental regulations. Section four presented environmental management systems, followed by a section on standardization. Section six discussed European organizations involved in electricity issues, while the following section dealt with European commission programs. The last section briefly looked at the trends in the electricity sector, broaching topics such as compliance, electricity generation, and emissions trading. 52 refs., 2 tabs

  19. Study on freshness quality and post-harvest loss of Hilsa (Tenualosa Ilisha during marketing in Mymensingh town, Bangladesh

    Directory of Open Access Journals (Sweden)

    Dilip Chandra Ray

    2015-08-01

    Full Text Available An investigation was conducted to know the freshness quality and associated post-harvest loss of hilsa, if any, transported to Mymensingh from the major landing centers through Cox’s Bazar-Chittagong (route A and Barguna-Chandpur (route B routes for a period of July to October 2012. The average environmental temperature of the wholesale and retail markets was 30.7 °C and 30.6 °C where the body temperature of hilsa was 4.5 °C (route A and 4.7 °C (route B, respectively. The Freshness quality of hilsa was assessed using sensory defects points (DPs that eventually gave rise to numerical values ‘1’ being the freshest and ‘5’ being the worst quality. The DPs of hilsa were found 2.0, which reveal that the fishes were in excellent conditions, i.e., there was no significant post-harvest loss even during retail sale. DPs on arrival and at wholesale in July, September and October were significantly different after auction and during retail sale (p<0.05, and in August differed significantly only during retail sale (p<0.05. It was observed that hilsa transported to Mymensingh from Barguna-Chandpur were better in quality than those transported from Cox’s Bazar-Chittagong. The reason behind this finding was not studied and this needs to be elucidated through further research.

  20. 77 FR 42052 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; NYSE Arca, Inc.; Order Instituting...

    Science.gov (United States)

    2012-07-17

    ... Gary L. Gastineau, Managing Member, ETF Consultants LLC, dated June 11, 2012 (``ETF Consultants Letter..., NASDAQ would allocate available MQP Market Maker registrations in a first-come-first-served fashion based...

  1. 77 FR 77141 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule...

    Science.gov (United States)

    2012-12-31

    ... exposure or to express a directional view as a core or satellite component to one's investment portfolio... influence the selection or retention of MQP Market Makers, or the amount of incentive credits that any...

  2. Welfare distribution effect of a price reduction in the Dutch gas transport market: A scenario analysis of regulatory policy, market form and rent allocation

    NARCIS (Netherlands)

    A. Witteloostuijn, van (Arjen); S. Brakman (Steven); J.G.M. van Marrewijk (Charles)

    2007-01-01

    textabstractAs part of the larger energy market deregulation program, the Dutch energy authority—DTe—has developed the habit to force the Dutch gas transport enterprise—Gas Transport Services, or GTS—to lower its prices. DTe's key argument is that lower gas transport prices will benefit the

  3. Welfare distribution effect of a price reduction in the Dutch gas transport market: A scenario analysis of regulatory policy, market form and rent allocation

    NARCIS (Netherlands)

    Witteloostuijn , van Arjen; Brakman, S.; van Marrewijk, C.

    2007-01-01

    As part of the larger energy market deregulation program, the Dutch energy authority-DTe-has developed the habit to force the Dutch gas transport enterprise-Gas Transport Services, or GTS-to lower its prices. DTe's key argument is that lower gas transport prices will benefit the end-user. Indeed,

  4. 77 FR 62290 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-10-12

    ... and self-regulatory organizations to do so by submitting a single form, fingerprint card and a... identical fee for FINRA's review of a Form BD submitted by NASDAQ members that are not members of FINRA. \\8... filing, and fingerprint fees would become effective for filings or fingerprints submitted on or after...

  5. 78 FR 26820 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2013-05-08

    ... affiliate relationship between NASDAQ and NOS, its member, raises the issue of an exchange's affiliation... unfair competitive advantage and potential conflicts of interest between an exchange's self-regulatory... regarding the potential for conflicts of interest in instances where a member firm is affiliated with an...

  6. 78 FR 55302 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-09-10

    ... categories of rules and regulations generally applicable to such persons.\\7\\ The Continuing Education... the continuing education. B. Self-Regulatory Organization's Statement on Burden on Competition NASDAQ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70316; File No. SR-NASDAQ-2013-108] Self...

  7. 75 FR 5822 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-02-04

    ... with several rules that represented a consolidation of the old NASD and NYSE rules concerning financial... Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To Amend Its Financial Responsibility Rules... Financial Industry Regulatory Authority (``FINRA''). The Exchange will implement the proposed rule change...

  8. 75 FR 29592 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-05-26

    ... Corporate Governance Requirements May 19, 2010. Pursuant to Section 19(b)(1) of the Securities Exchange Act... companies to provide notification to Nasdaq of any noncompliance with the corporate governance requirements... Regulatory Authority. A Company may be denied continued listing if it fails to provide such information...

  9. 76 FR 75924 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-12-05

    ...-Regulatory Organization's Statement of the Terms of the Substance of the Proposed Rule Change The Exchange... executions, executions by symbol, add versus remove, buy versus sell, display versus non-display, number of... QView service is similar to the services offered by the BATS exchange through its online member portal...

  10. Development of post-harvest protocol of okra for export marketing.

    Science.gov (United States)

    Dhall, R K; Sharma, S R; Mahajan, B V C

    2014-08-01

    The study was carried out on the harvesting and handling methods of okra with the objective to maintain the best quality of pods from harvesting to end consumer especially for export marketing. For that purpose okra cv. 'Punjab-8' pods were harvested with minimum handling (least injuries to the pubescence on the ridges of pod) and normal handling (no safety taken to prevent injuries on pods). Pods were precooled at 15 ± 1ºC, 90-95% RH; jumble packed in the CFB boxes of 2.0 Kg capacity and than stored at 8 ± 1ºC, 90-95% RH. The quality parameters of okra namely texture, chlorophyll content, physiological loss in weight, rotting percentage and general appearance were studied. The pods harvested with minimum handling and field packaging can retain their green colour, crisp texture (maximum force to puncture pod = 500.2 g) with minimum rotting (3.0%) and physiological loss in weight (15.8%) and good appearance upto 13 days of cold storage whereas normal handled pods can be stored upto 5 days at 8 ± 1ºC, 90-95% RH and thereafter lost their general appearance on the 7th day of storage and were discarded. Therefore, in order to maintain high quality of okra from harvesting to the final destination (consumer), the okra pods should be harvested with minimum handling followed by field packaging in CFB boxes.

  11. Regulatory affairs for biomaterials and medical devices

    CERN Document Server

    Amato, Stephen F; Amato, B

    2015-01-01

    All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller co

  12. 76 FR 9391 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-02-17

    ... from a range of possible, and equally reasonable, pricing strategies as the means of recovering total... for accessing posted liquidity. Other platforms may choose a strategy of paying lower rebates (or no... 9394

  13. The electricity prices in the European Union. The role of renewable energies and regulatory electric market reforms

    International Nuclear Information System (INIS)

    Moreno, Blanca; López, Ana J.; García-Álvarez, María Teresa

    2012-01-01

    The European Union electricity market has been gradually liberalized since 1990s. Theoretically, competitive markets should lead to efficiency gains in the economy thus reducing electricity prices. However, there is a controversial debate about the real effects of the electricity liberalization on electricity prices. Moreover, the increased generation of electricity from renewable energies RES-E (Electricity from Renewable Energy Sources) is also integrated in wholesale market reducing wholesale prices, but the final effect over household prices is not clear. In order to contribute to this debate, this paper provides an empirical investigation into the electricity prices determinants. In fact we develop econometric panel models to explore the relationship between the household electricity prices and variables related to the renewable energy sources and the competition in generation electricity market. More specifically we use a panel data set provided by Eurostat and covering 27 European Union countries during the period 1998–2009. Our results suggest that electricity prices increase with the deployment of RES-E and with the expansion of greenhouse gas emissions produced by energy industries- as a European Union CO 2 emission trading scheme exists. Results also reveal that country's characteristics can affect household electricity prices. -- Highlights: ► Electricity liberalized markets should lead to reduce electricity prices. ► The use of renewable energies (RES) reduce wholesale electricity prices. ► However, household electricity prices are increasing in European Union. ► Panel data models are developed to investigate the effect of RES and electricity competition on household electricity prices. ► We find that the deployment of RES increases prices paid by consumers in a liberalized market.

  14. Using Research Case Studies in eCommerce Marketing Courses: Customer Satisfaction at Point-of-Purchase and Post-Purchase

    Science.gov (United States)

    Nawi, Noorshella Che; Fong, Michelle; Tatnall, Arthur

    2014-01-01

    This paper describes a research case study of Internet apparel marketing by small businesses in Malaysia which can beneficially be included in postgraduate business courses for understanding the importance of measuring customer satisfaction at point-of-purchase and post-purchase in online purchases. The sample size in this research is 154…

  15. Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Government & Policy-Makers

    Science.gov (United States)

    Wheelahan, Leesa; Buchanan, John; Yu, Serena

    2015-01-01

    This summary brings together the relevant key findings for government and policy-makers from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education and…

  16. Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Tertiary Education Providers & School Educators

    Science.gov (United States)

    Wheelahan, Leesa; Buchanan, John; Yu, Serena

    2015-01-01

    This summary brings together the relevant key findings for tertiary education providers and school educators from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between…

  17. Safety and Effectiveness of Natalizumab: First Report of Interim Results of Post-Marketing Surveillance in Japan.

    Science.gov (United States)

    Saida, Takahiko; Yokoyama, Kazumasa; Sato, Ryusuke; Makioka, Haruki; Iizuka, Yukihiko; Hase, Masakazu; Ling, Yan; Torii, Shinichi

    2017-12-01

    Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillance of natalizumab-treated MS patients from Japan to investigate the safety and effectiveness of natalizumab in a real-world clinical setting in Japan. Here, we report the results of an interim analysis. During the observation period of 2 years, all patients who were treated with natalizumab subsequent to its approval in Japan were followed. The effectiveness of natalizumab was assessed by examining the changes in expanded disability status scale (EDSS) score and annualized relapse rate (ARR) from baseline. Safety was assessed by analyzing the incidence of adverse drug reactions (ADRs). The safety analysis included 106 patients (mean age 39.3 years; women 62.3%) whose data were collected until the data lock point (February 7, 2016). The effectiveness analysis included 75 patients. The majority of patients had relapsing-remitting MS (93/106 patients; 87.7%). The mean length of treatment exposure in the present study was 6.6 months. During the 2-year observation period, no significant change in the EDSS was observed, while the ARR decreased significantly from baseline (72.9% reduction, p = 0.001). ADRs and serious ADRs were observed in 11.3% and 3.8% of patients, respectively; however, no new safety concerns were detected. No patient had progressive multifocal leukoencephalopathy (PML) during the present study period. The safety and effectiveness of natalizumab were confirmed in Japanese patients with MS in clinical practice. Nevertheless, potential risks including PML require continuous, careful observation. Biogen Japan Ltd (Tokyo, Japan).

  18. Post-marketing access to orphan drugs: a critical analysis of health technology assessment and reimbursement decision-making considerations

    Directory of Open Access Journals (Sweden)

    Iskrov G

    2014-01-01

    Full Text Available Georgi Iskrov, Rumen Stefanov Department of Social Medicine and Public Health, Medical University of Plovdiv, Plovdiv, Bulgaria Abstract: This study aims to explore the current rationale of post-marketing access to orphan drugs. As access to orphan medicinal products depends on assessment and appraisal by health authorities, this article is focused on health technology assessment (HTA and reimbursement decision-making considerations for orphan drugs. A critical analysis may identify important factors that could predetermine the combined outcomes of these two processes. Following this objective, an analytical framework was developed, comprising three overlaying issues: to outline what is currently done and what needs to be done in the field of HTA of orphan drugs, to synthesize important variables relevant to the reimbursement decision-making about orphan drugs, and to unveil relationships between theory and practice. Methods for economic evaluation, cost-effectiveness threshold, budget impact, uncertainty of evidence, criteria in reimbursement decision-making, and HTA research agenda are all explored and discussed from an orphan drug perspective. Reimbursement decision-making for orphan drugs is a debate of policy priorities, health system specifics, and societal attitudes. Health authorities need to pursue a multidisciplinary analysis on a range of criteria, ensuring an explicit understanding of the trade-offs for decisions related to eligibility for reimbursement. The only reasonable way to accept a higher valuation of orphan drug benefits is if these are demonstrated empirically. Rarity means that the quality of orphan drug evidence is not the same as for conventional therapies. Closing this gap is another crucial point for the timely access to these products. The generation of evidence goes far beyond pre-market authorization trials and requires transnational cooperation and coordination. Early constructive dialogue among orphan drug

  19. Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations

    Directory of Open Access Journals (Sweden)

    Wang C

    2018-04-01

    Full Text Available Can Wang,1,2 Qing-ping Shi,1,2 Feng Ding,2 Xiao-dong Jiang,1,2 Wei Tang,3 Mei-Ling Yu,1,2 Jian-Hua Zhu2 1Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People’s Republic of China; 2Faculty of Pharmacy, Bengbu Medical College, Bengbu, People’s Republic of China; 3Department of Pharmacy, Huaiyuan County Hospital of TCM in Anhui, Bengbu, People’s Republic of China Aim: To evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening.Methods: This study used a prospective, nested case–control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening.Results: The results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674, and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760 when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single

  20. 78 FR 59391 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-09-26

    ... NASDAQ cross connect handoffs (1G, 10G, or 40G) to receive the multicast market data for CME Group, and... unnecessary because the 12-month minimum subscription no longer applies. Clients are now able to connect for a short period of time, test the product, and then disconnect without penalty at any time if the product...

  1. 77 FR 3019 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-01-20

    ... national best offer, as appropriate, shrinks to the greater of: (a) 4 percentage points, or, (b) one... pricing obligations (i) shall not commence during any trading day until after the first regular way...-commence until after the first regular way transaction on the primary listing market in the security...

  2. 76 FR 13694 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-03-14

    ... system which NASDAQ operates or controls, and it is designed to promote just and equitable principles of... Release No. 61358 (January 14, 2010), 75 FR 3594 (January 21, 2010) (Concept Release on Equity Market Structure, ``Concept Release''). In the Concept Release, the Commission has recognized the strong policy...

  3. 76 FR 55954 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-09-09

    ... of Substance of the Proposed Rule Change NASDAQ proposes to modify pricing for NASDAQ members using... its pricing schedule for routing and execution of quotes/orders through the NASDAQ Market Center of... entering Directed Orders sent to NASDAQ OMX PSX. The current charge of $0.0027 reflects a premium of $0...

  4. 78 FR 17985 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-03-25

    ... with customer bases of potential product users have indicated a preference that premium pricing for... options on the same security. In addition to giving market participants clarity as to the minimum pricing increments for Mini Options, the filing would harmonize penny pricing between Mini Options and standard...

  5. 77 FR 20666 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-04-05

    .... Baumol and Daniel G. Swanson, ``The New Economy and Ubiquitous Competitive Price Discrimination... (``BDs'') increased authority and flexibility to offer new and unique market data to the public. It was... source of the information that is distributed) and are each subject to significant scale economies. In...

  6. 76 FR 41845 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-07-15

    .... Baumol and Daniel G. Swanson, ``The New Economy and Ubiquitous Competitive Price Discrimination... broker-dealers (``BDs'') increased authority and flexibility to offer new and unique market data to the... source of the information that is distributed) and are each subject to significant scale economies. In...

  7. 78 FR 75657 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-12-12

    ... and transaction charges incurred by the Exchange as well as certain other costs incurred by the... to recoup these costs borne by the Exchange on each transaction. The $0.20 per contract Customer... costs, in addition to the transaction fee assessed by the away market. \\10\\ See note 8 [sic]. In...

  8. 77 FR 41467 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-07-13

    .... Baumol and Daniel G. Swanson, ``The New Economy and Ubiquitous Competitive Price Discrimination... authority and flexibility to offer new and unique market data to the public. It was believed that this... source of the information that is distributed) and are each subject to significant scale economies. In...

  9. 77 FR 1537 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-01-10

    ... William J. Baumol and Daniel G. Swanson, ``The New Economy and Ubiquitous Competitive Price Discrimination...'') increased authority and flexibility to offer new and unique market data to the public. It was believed that... economies. In such cases, marginal cost pricing is not feasible because if all sales were priced at the...

  10. 76 FR 63334 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-10-12

    ... William J. Baumol and Daniel G. Swanson, ``The New Economy and Ubiquitous Competitive Price Discrimination... broker-dealers (``BDs'') increased authority and flexibility to offer new and unique market data to the... economies. In such cases, marginal cost pricing is not feasible because if all sales were priced at the...

  11. 78 FR 35656 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval to Proposed...

    Science.gov (United States)

    2013-06-13

    ... that internalize much of the market's retail order flow off-exchange, and that the Program, as modified... significant shares of retail order flow to the Program because the cost of complying with the current ``any... imposes a higher threshold for order flow segmentation purposes. Third, the commenter contended that the...

  12. 78 FR 62820 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-10-22

    ... Limiting Access to their Services'' that purports to challenge prior filings under Section 19(d) and (f) of... proceeding with respect to NYSEArca data product). As with prior SIFMA challenges, the pendency of SIFMA's... to which NASDAQ distributes the NASDAQ Last Sale (``NLS'') market data products. NLS allows data...

  13. 78 FR 76347 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-12-17

    ... definitions of Consolidated Volume for pricing purposes, but would continue to be included in the member's own.... Pricing tiers that require participation in both the NASDAQ Market Center and NOM recognize the prevalence of trading in which members simultaneously trade different asset classes within the same strategy...

  14. 75 FR 67788 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2010-11-03

    ..., and no less frequently than twice per week. (d) The Company must publish its Net Market Value (``NMV... accounting or auditing matters. The rights and responsibilities as articulated in the audit committee charter... public accounting firms, (ii) complaints relating to accounting, internal accounting controls or auditing...

  15. 76 FR 9384 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-02-17

    ... are executed in dark pools. Securities Exchange Act Release No. 61358 (January 14, 2010), 75 FR 3594... wide range of market structure issues, including high frequency trading and un- displayed, or ``dark... of New York, Sept. 7, 2010) (``Schapiro Speech,'' available on the Commission Web site) (comments of...

  16. 77 FR 54640 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2012-09-05

    ... debt or interest rates. The Fund also may buy or sell listed currency futures contracts.\\23\\ \\23\\ The.... government securities as U.S. or non-U.S. government securities, as applicable. Global Corporate Debt The... under normal market conditions. Effective duration is an indication of an investment's interest rate...

  17. 78 FR 6379 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-01-30

    ... operative delay period contained in Exchange Act Rule 19b- 4(f)(6)(iii).\\4\\ The text of the proposed rule... concept of leverage is not novel to the markets, the Information Circular will be distributed to provide... system, and, in general to protect investors and the public interest. For the reasons noted in the filing...

  18. 77 FR 14456 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-03-09

    ... operative on March 1, 2012. The text of the proposed rule change is available on the Exchange's Web site at..., fees and other charges among members and issuers and other persons using any facility or system which... Release No. 61358 (January 14, 2010), 75 FR 3594 (January 21, 2010) (Concept Release on Equity Market...

  19. 76 FR 59466 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Disapproving a Proposed Rule...

    Science.gov (United States)

    2011-09-26

    ... Market Data Fees and Transaction Execution Fees September 20, 2011. I. Introduction On January 10, 2011... dated April 4, 2011 from Joan Conley, Senior Vice President, NASDAQ OMX Group, Inc. to Elizabeth M... believe that NASDAQ's ``joint products'' theory is fundamentally flawed, and cannot support the conclusion...

  20. 75 FR 61797 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-10-06

    ... amending Section 11 to include a definition of ``System routing table,'' defined as the proprietary process... Locked and Crossed Market Rules. \\3\\ Nasdaq has previously defined the term ``System routing table'' in... better value is the essence of a well-functioning competitive marketplace. The Exchange also believes...

  1. 75 FR 16224 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-03-31

    ... Proposed Rule Change To Delay the Application of NASDAQ Rule 4611(d) March 24, 2010. Pursuant to Section 19... rule change to delay the application of NASDAQ Rule 4611(d) until 180 days following its approval. The... Market Access Rule. Accordingly, NASDAQ is proposing to delay for 180 days from approval the...

  2. 75 FR 41918 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-07-19

    ... Proposed Rule Change To Delay the Application of NASDAQ Rule 4611(d) July 13, 2010. Pursuant to Section 19... proposed rule change to delay the application of NASDAQ Rule 4611(d) for an additional 180 days. The text... proposed to delay implementation of the Market Access Rule, based upon conversations with industry...

  3. 75 FR 53994 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2010-09-02

    ... investor concerns. The link between failure to comply with the bid price requirement and failure to meet... market system, and, in general, to protect investors and the public interest. The proposed rule change is... address instances of noncompliance with Nasdaq's price requirement and would not adversely affect...

  4. 75 FR 47670 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-08-06

    ... NIKE Inc. 282 EWW iShares MSCI 335 FIS Fidelity Mexico National Investable Information Market Index... Inc. 316 CB Chubb Corp. 205 MA Mastercard Inc. 320 ADM Archer-Daniels- Midland Co. 224 ATPG ATP Oil & Gas 322 HSY Hershey Co./The Corp/United States 226 YUM Yum! Brands Inc 323 TXT Textron Inc. 232 RCL...

  5. 77 FR 64167 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2012-10-18

    ..., it provides a more intelligent form of market order. Instead of having the order execute at the...., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the...

  6. 76 FR 61416 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2011-10-04

    ... recommended that the markets consider replacing the Dow Jones Industrial Average (``DJIA'') with the S&P 500[reg] Index (``S&P 500''), revising the 10%, 20%, and 30% decline percentages, reducing the length of... by the Committee, using an index that correlates closely with derivative products, such as the E-Mini...

  7. 78 FR 24282 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-04-24

    ... Change NASDAQ proposes to amend Chapter XV, entitled ``Options Pricing,'' at Section 2 governing pricing... recoup costs that the Exchange incurs for routing and executing orders in equity options to various away... orders routed to any away market and the Exchange assesses Customer orders a fixed fee plus the actual...

  8. 77 FR 23788 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-04-20

    ... is reasonable to recoup the BATS remove fees plus the clearing and other costs to recoup Routing Fees... Change The NASDAQ Stock Market LLC proposes to modify Chapter XV, Section 2, governing pricing for NASDAQ... purpose of this rule filing is to recoup costs that the Exchange incurs for routing and executing Customer...

  9. 75 FR 11213 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-03-10

    ... impact of the modest price increases upon the net fees paid by a particular market participant will... securities that it trades, and its usage of Mid-Point Pegged Orders. NASDAQ notes that it operates in a... the following methods: Electronic Comments Use the Commission's Internet comment form ( http://www.sec...

  10. 76 FR 35498 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-06-17

    ... feed will also provide data regarding contingency orders and complex strategies. The monthly fee... advertising revenue. Retail broker-dealers, such as Schwab and Fidelity, offer their customers proprietary... Phlx's competitive success. If Phlx cannot attract order flow to its market, it will not be able to...

  11. 78 FR 16898 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-03-19

    ... multiply-listed equity and ETF options classes in a month \\11\\ or (3) adds Customer and Professional... the following symbols, iShares MSCI Emerging Markets Index (``EEM''), SPDR Gold Shares (``GLD''), i... and ETF options classes in a month or add Customer and Professional liquidity of 60,000 or more...

  12. 78 FR 6382 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-01-30

    ... proposes to list Mini Options on SPDR S&P 500 (``SPY''), Apple, Inc. (``AAPL''), SPDR Gold Trust (``GLD... same terms and contract characteristics as regular-sized equity and ETF options, including exercise... and ETF options would apply, including Market Maker obligations, to Mini Options.\\9\\ \\9\\ See Chapter...

  13. 77 FR 6831 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-02-09

    ... correlation observed by NASDAQ between levels of liquidity provided during pre-market hours and levels... extra rebate with respect to all displayed liquidity provided through a designated MPID that executes at... Execution Ratio'' for the month is less than 10. The PMI Execution Ratio is defined as the ratio of (A) the...

  14. 78 FR 56962 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-09-16

    ... to impose the fee on a particular MPID is made by calculating the ratio between (i) entered orders... fee is imposed on MPIDs that have an ``Order Entry Ratio'' of more than 100. through such MPID the... contribution to market quality by providing liquidity at the NBBO in a large number of stocks for a significant...

  15. 75 FR 14227 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2010-03-24

    ... Commission has considered the proposed rule's impact on efficiency, competition, and capital formation. See... its rules governing NOM, the Securities Industry and Financial Markets Association (``SIFMA... security.''). See also Newton v. Merrill, Lynch, Pierce, Fenner & Smith, Inc., 135 F.3d 266, at 271, 274...

  16. 75 FR 28839 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule...

    Science.gov (United States)

    2010-05-24

    ... individual stocks contained in the Standard & Poor's 500 Index (``S&P 500'') that experience a price change... this paragraph will be calculated by changes in each consolidated last-sale price disseminated by a... the primary listing market if the price of such security moves 10% or more from a sale in a preceding...

  17. 78 FR 19549 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-04-01

    ... product for trading on NOM. The Exchange is not offering at this time any rebate per trade to... necessary for the product to trade on NOM due to its smaller exercise and assignment value of a Mini Option... that the differentiation between the rebates offered to Customers as compared with all other market...

  18. 78 FR 16006 - Self-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Science.gov (United States)

    2013-03-13

    ...Tree Emerging Markets Corporate Bond Fund). Additionally, the Commission has previously approved the... invest primarily in Senior Loans that are below investment grade quality and will rely on fundamental... include thrift institutions, insurance companies or finance companies (or their affiliates). Such...

  19. 75 FR 6072 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2010-02-05

    ... delisting process if such rule changes are found to benefit Nasdaq's financial position.\\46\\ [[Page 6075... SEC filing made by listing companies, including proxies and annual and quarterly financial reports... the changes that have taken place in the financial markets, the existing time periods are unreasonably...

  20. 78 FR 17962 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-03-25

    ... volatility. Economically Equivalent Products The Exchange has considered the existence of economically... accelerated rate, which the Exchange believes is a direct result of the implementation of the Delta-Based... limits thereon are eliminated. \\26\\ See SPXPM Approval at 55972. Market on Close Volatility The Exchange...

  1. 76 FR 75593 - Self-Regulatory Organizations; The NASDAQ Stock Market, LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-12-02

    ... strictly regulating the price that an automobile manufacturer can charge for car sound systems despite the existence of a highly competitive market for cars and the availability of aftermarket alternatives to the... to their advertising revenue. Retail broker-dealers, such as [[Page 75597

  2. 76 FR 4970 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-01-27

    ... investors by providing an incentive for them to trade in the well-regulated, publicly-displayed market that... has also been reported that NYSE Amex has offered equity incentives to active members. While Nasdaq is...-professional data usage--is completely consistent with economic theory and past Commission precedent. \\15\\ As...

  3. Coordination of improvement of higher education personnel: regulatory officer field of post-graduate studies in Brazil

    Directory of Open Access Journals (Sweden)

    Rogerio Junior Boratim

    2014-12-01

    Full Text Available This paper aims to present a sociological reflection on the role of the Coordination of Improvement of Higher Education Personnel (CAPES as the regulator that institutionalized the field of postgraduate studies in Brazil with public universities. The methodological and theoretical assumptions underpin the theory of the scientific field of Pierre Bourdieu and seek to demonstrate that the CAPES as a political entity linked to the federal government brokered and legitimized the involvement of the holders of teacher-researchers greater symbolic capital (scientific recognition among peers-competitors , giving them the prerogative to set rules for the evaluation and funding of post-graduate studies. Nevertheless, these legitimate borrowers (dominant in the field of post-graduate consolidated merit system amalgamated by one academic productivism, establishing universities within a performance culture that brings the trailer individualism, utilitarianism and the casualization of labor and relations in the university field.

  4. Market Power in Power Markets: Evidence from Forward Prices of Electricity

    DEFF Research Database (Denmark)

    Christensen, Bent Jesper; Jensen, Thomas Elgaard; Mølgaard, Rune

    We examine the forward market for electricity for indications of misuse of market power, using a unique data set on OTC price indications posted by Elsam A/S, the dominant producer in Western Denmark, which is one of the price areas under the Nordic power exchange Nord Pool. The Danish Competition...... Council (the regulatory government agency) has ruled that Elsam has used its dominant position to obtain excessive spot prices over a period from July 2003 through December 2006. We show that significant forward premia exist, and that they are related both to spot market volatility and misuse of market...... are consistent across forward premium regressions and structural forward pricing models....

  5. Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

    Science.gov (United States)

    Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

    2017-11-01

    Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

  6. Clinical safety and efficacy of "filgrastim biosimilar 2" in Japanese patients in a post-marketing surveillance study.

    Science.gov (United States)

    Tamura, Kazuo; Hashimoto, Kazue; Nishikawa, Kiyohiro

    2018-05-01

    We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5.26%). Back pain was most frequently observed and reported in 20 patients (3.19%), followed by pyrexia (1.28%) and bone pain (0.96%). Risk factors for adverse reactions identified by logistic regression analyses were younger age, presence of past medical history, and lower total dose at the onset of adverse reactions. Among the 576 cancer patients who developed Grade 2-4 neutropenia after chemotherapy, recovery to Grade 1/0 was reported in 553 patients (96%) following filgrastim biosimilar 2 treatment. The median duration of neutrophil counts below 1500/μL was 5 days. In addition, all 11 patients who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this study showed that filgrastim biosimilar 2 has a similar safety profile and comparable effects to the original G-CSF product in the real world clinical setting. Copyright © 2018 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  7. [Safety and efficacy of docetaxel in prostate cancer patients: based on the post-marketing surveillance in Japan].

    Science.gov (United States)

    Mera, Takeshi; Saijo, Nagahiro; Akaza, Hideyuki

    2012-04-01

    The safety and efficacy of docetaxel in prostate cancer were evaluated based on the results of post-marketing surveillance. 149 patients were enrolled between September 2008 and May 2010. The starting dose of docetaxel was 75 mg/m² in 53 patients(36%), 70 mg/m² in 55 (37%), and ≤ 60 mg/m² in 41(28%). The median number of treatment cycles was 8 (range, 1 to 10). There was no age difference observed in the starting doses and the treatment cycles. The most common ≥ grade 3 adverse drug reactions (ADRs) were neutropenia (71%)and leukocytopenia (51%), and they occurred more frequently in patients receiving ≥ 70 mg/m². However, the multi-variate analyses revealed that ≥ grade 3 ADRs did not correlate with the starting doses. Infection-related events (≥ grade 3) and interstitial pneumonia were observed in 15% and 1% of patients, respectively. Prostate-specific-antigen (PSA) flare appeared in 19% of 95 evaluable patients at median period of 26 days from treatment initiation. It continued with median duration of 39. 5 days. PSA response rate as defined ≥ 50% level decline was 37%(95%confidence interval: 27-47) in evaluable patients. It was low in patients receiving ≤ 60 mg/m² (18%). There was no notable difference between patients with initial dose of 75 and 70 mg/m². Further investigation for the longer term is warranted.

  8. Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis.

    Science.gov (United States)

    Takeuchi, Tsutomu; Kawai, Shinichi; Yamamoto, Kazuhiko; Harigai, Masayoshi; Ishida, Kota; Miyasaka, Nobuyuki

    2014-01-01

    A post-marketing surveillance (PMS) program was implemented to assess the safety and effectiveness of tacrolimus (TAC) in Japanese rheumatoid arthritis (RA) patients and to identify risk factors related to adverse drug reactions (ADRs). Patients were registered centrally and monitored for all adverse events (AEs) for 24 weeks. Effectiveness was evaluated using the Disease Activity Score 28-CRP (DAS28-CRP). Data from 3,172 patients (mean age 62.2 years) were evaluated in the safety analysis. Of the safety population, 78.5 %were female and 25.9 % were in Steinbrocker's functional class 3 or 4. TAC was prescribed as monotherapy in 52.5 % and the most common concomitant disease modifying antirheumatic drug (DMARD) was methotrexate, used in 28.9 % of the patients. The incidence of AEs, serious AEs (SAEs), ADRs and serious ADRs were 41.2, 6.4, 36.0, and 4.9 %, respectively. The most frequent serious ADR category was infections and infestations. Age ≥ 65 years, concurrent renal dysfunction, and concurrent diabetes mellitus were identified as significant risk factors for ADR. Based on EULAR response criteria, 65.4 % of the patients showed moderate or good response. The results demonstrate that TAC is well tolerated by Japanese patients with active RA, including those receiving concomitant methotrexate, in the real world.

  9. Safety and effectiveness of certolizumab pegol in patients with rheumatoid arthritis: Interim analysis of post-marketing surveillance.

    Science.gov (United States)

    Kameda, Hideto; Nishida, Keiichiro; Nannki, Toshihiro; Watanabe, Akira; Oshima, Yukiya; Momohara, Shigaki

    2017-01-01

    Objective: To evaluate the safety and effectiveness of certolizumab pegol (CZP) in a real-world setting among Japanese patients with rheumatoid arthritis. Post-marketing surveillance data from 2,579 patients treated with CZP were analyzed. Adverse events (AEs) observed during the 24-week CZP treatment period were recorded. Disease activity was evaluated using DAS28-ESR and DAS28-CRP at baseline, Week 12, Week 24, or at withdrawal. The total period of exposure to CZP was 1313.8 patient-years (PY). AEs were reported in 658 (25.5%) patients, at an event rate (ER) of 73.68/100 PY. The most frequent serious AEs were pneumonia, herpes zoster, and interstitial lung disease, at ER per 100 PY of 2.06, 1.29, and 1.22, respectively. Mean disease activity scores at baseline, as measured by DAS28-ESR and DAS28-CRP, were 4.77 ± 1.34 and 4.21 ± 1.27, respectively. Mean changes from baseline at the last observation were -1.29 ± 1.46 and -1.30 ± 1.42, respectively. EULAR good or moderate responses were achieved in 65% of patients. Longer disease duration, prior biologics use, and treatment without MTX co-therapy were associated with EULAR no response. In this interim analysis, no new safety signals were observed. Clinical response to CZP was observed in approximately two thirds of patients.

  10. Safety and efficacy of adapalene gel 0.1% in acne vulgaris: Results of a post-marketing surveillance study

    Directory of Open Access Journals (Sweden)

    Percy S

    2003-07-01

    Full Text Available Introduction: Adapalene is a novel retinoid indicated for the topical treatment of acne vulgaris. The drug was introduced in India in 2001. Aims: A post-marketing surveillance study was conducted to assess the safety and efficacy of adapalene gel 0.1% when used as monotherapy or in combination with other anti-acne agents in Indian patients of acne vulgaris. Material and Methods: A 12-week, multicentre, open-label, non-comparative study involving 571 patients from 21 centers across India was conducted between January and September of 2002. Concomitant prescription of other anti-acne drugs was permitted, if needed. Results: Of the 571 patients, 441 completed the treatment as per protocol. At the end of therapy, 96.3% of patients showed an improvement in their acne from baseline, with greater than 75% improvement seen in two-thirds of patients. Adverse events were reported in 24% of the patients, none of which were serious. The tolerability of therapy was rated as excellent/good in 81% of patients by physicians and in 78% by the patients. Conclusion: Adapalene gel 0.1% is a safe and effective topical agent in the treatment of mild to moderate acne vulgaris in Indian patients. It may be safely combined with other topical and oral anti-acne agents.

  11. Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance.

    Science.gov (United States)

    Sessa, Maurizio; Rossi, Claudia; Mascolo, Annamaria; Grassi, Enrico; Fiorentino, Sonia; Scavone, Cristina; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

    2015-01-01

    During the last years in Italy, contrast media (CM) use increased. An increase of monitoring activities on CM-induced adverse drug reaction (ADR) is necessary, also in our regional territory. The main aim of this study was to give a preliminary evaluation of all Spontaneous Reports of ADRs (SRA) attributed to CM sent to Campania Pharmacovigilance Regional Center (CRFVC) from 01 January 2001 to 31 October 2014. For each SRA we evaluated: frequency and source, ADRs onset (time to event, seriousness and outcome), socio-demographic characteristics and risk factors of cases, the most reported CM (checking for pharmacodynamic and pharmacokinetic interactions). A total of 111 SRA were sent to CRFVC; specialist in radiology was the main source of reports. Ninety-seven SRA (87.3%) were referable to hypersensitivity reactions. Thirty-four SRA (30.6%) reported serious ADRs. The most reported CM were iopamidol, gadobenic acid and gadoteric acid. We identified two SRA induced by pharmacokinetic and/or pharmacodynamic interactions. During 14 years of post-marketing surveillance, only few SRA concerning CM-induced ADRs were sent to CRFVC probably due to underreporting. We aim to improve monitoring activity on CM-induced ADRs especially in hospitals. Most reported ADR and CM were in line with current body of literature.

  12. Volume Shocks around Announcements in the Chinese Stock Market: An Ex-Post Earnings-Information-Based Study of Speculative Behavior

    Directory of Open Access Journals (Sweden)

    Xiangdong Chen

    2017-09-01

    Full Text Available The Second Board Market is typical stock market for high tech companies in China. This paper discusses the relationship between trading volume and price changes in the case of high-tech listed companies in the Chinese Second-Board Stock Market. By using the basic concepts proposed by Kim and Verrecchia, and Kandel and Pearson, and contrasting them with ex-post information from earnings releases, the paper provides findings on the speculative behavior of informed traders with a volume shock premium. The paper suggests that these methods may be further applied to investigating investors’ behavior in speculation, especially for the high-tech-company-based Second-Board Stock Market during announcement periods.

  13. 76 FR 37388 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-06-27

    ..., please use only one method. The Commission will post all comments on the Commission's Internet Web site...) (requiring a company to, among other things, identify each director that is independent and explain the.... Differences include where Item 407(a)(2) of Regulation S-K requires specific disclosures when a registrant...

  14. 76 FR 31998 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2011-06-02

    ... participant entered a Post-Only Order to buy at $10.05, the order would be re-priced and displayed at $10.04...-Only Order to buy at $10.01 is entered, the order will execute at $10. This aspect of the order's..., the rule is being amended to provide a complete description of the order's current behavior when...

  15. 75 FR 64379 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-10-19

    ... platforms may choose from a range of possible, and equally reasonable, pricing strategies as the means of... high prices for accessing posted liquidity. Other platforms may choose a strategy of paying lower... fierce competition for the inputs necessary to the creation of proprietary data and strict pricing...

  16. 75 FR 57321 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-09-20

    ... from a range of possible, and equally reasonable, pricing strategies as the means of recovering total... for accessing posted liquidity. Other platforms may choose a strategy of paying lower rebates (or no... competition for the inputs necessary to the creation of proprietary data and strict pricing discipline for the...

  17. 75 FR 57314 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-09-20

    ... platforms may choose from a range of possible, and equally reasonable, pricing strategies as the means of... high prices for accessing posted liquidity. Other platforms may choose a strategy of paying lower... fierce competition for the inputs necessary to the creation of proprietary data and strict pricing...

  18. 75 FR 64370 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-10-19

    ... latency, fill rates, reliability, and cost. If shares remain un-executed after routing, they are posted to... routing tables at any time without notice. At present, all System routing tables include NASDAQ OMX BX... practices, to promote just and equitable principles of trade, to foster cooperation and coordination with...

  19. 77 FR 5862 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2012-02-06

    ... single $900/month. hub and router (for remote disaster recovery sites only). Option 1: Dual 56kb lines..., 2, or 3 (including any Message Queue software Bandwidth Enhancement Fee) plus 20%. enhancement... post all comments on the Commission's Internet Web site ( http://www.sec.gov/rules/sro.shtml ). Copies...

  20. Exploring the e-cigarette e-commerce marketplace: Identifying Internet e-cigarette marketing characteristics and regulatory gaps.

    Science.gov (United States)

    Mackey, Tim K; Miner, Angela; Cuomo, Raphael E

    2015-11-01

    The electronic cigarette (e-cigarette) market is maturing into a billion-dollar industry. Expansion includes new channels of access not sufficiently assessed, including Internet sales of e-cigarettes. This study identifies unique e-cigarette Internet vendor characteristics, including geographic location, promotional strategies, use of social networking, presence/absence of age verification, and consumer warning representation. We performed structured Internet search engine queries and used inclusion/exclusion criteria to identify e-cigarette vendors. We then conducted content analysis of characteristics of interest. Our examination yielded 57 e-cigarette Internet vendors including 54.4% (n=31) that sold exclusively online. The vast majority of websites (96.5%, n=55) were located in the U.S. Vendors used a variety of sales promotion strategies to market e-cigarettes including 70.2% (n=40) that used more than one social network service (SNS) and 42.1% (n=24) that used more than one promotional sales strategies. Most vendors (68.4%, n=39) displayed one or more health warnings on their website, but often displayed them in smaller font or in their terms and conditions. Additionally, 35.1% (n=20) of vendors did not have any detectable age verification process. E-cigarette Internet vendors are actively engaged in various promotional activities to increase the appeal and presence of their products online. In the absence of FDA regulations specific to the Internet, the e-cigarette e-commerce marketplace is likely to grow. This digital environment poses unique challenges requiring targeted policy-making including robust online age verification, monitoring of SNS marketing, and greater scrutiny of certain forms of marketing promotional practices. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  1. The applicability of animal health surveillance systems for post-market monitoring of potential adverse effects of genetically modified (GM) feed.

    Science.gov (United States)

    Vince, L; Kleter, G A; Kostov, K; Pfeiffer, D U; Guitian, J

    2018-04-20

    A facultative post market monitoring of potential health impacts of genetically modified (GM) feedstuffs on livestock consuming these feeds after pre-market risk assessment is under ongoing consideration. Within the IPAFEED database, scientific studies on health effects beyond performance in livestock and the results of a systematic search for evidence of outcome effects due to GM feed are consolidated. These outcomes were reviewed and checked for consistency in order to identify plausible syndromes suitable for conducting surveillance. The 24 selected studies showed no consistent changes in any health parameter. There were no repeated studies in any species by GM crop type and animal species. As such, there is insufficient evidence to inform the design of surveillance systems for detecting known adverse effects. Animal health surveillance systems have been proposed for the post market monitoring of potential adverse effects in animals. Such systems were evaluated for their applicability to the detection of hypothetical adverse effects and their strengths and weaknesses to detect syndromes of concern are presented. For known adverse effects, applied controlled post-market studies may yield conclusive and high-quality evidence. For detecting unknown adverse effects, the use of existing surveillance systems may still be of interest. A simulation tool developed within the project can be adapted and applied to existing surveillance systems to explore their applicability to the detection of potential adverse effects of GM feed. Copyright © 2018. Published by Elsevier Ltd.

  2. Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China.

    Science.gov (United States)

    Guo, Biao; Page, Andrew; Wang, Huaqing; Taylor, Richard; McIntyre, Peter

    2013-01-11

    China is the most populous country in the world, with an annual birth cohort of approximately 16 million, requiring an average of 500 million vaccine doses administered annually. In China, over 30 domestic and less than 10 overseas vaccine manufacturers supply over 60 licensed vaccine products, representing a growing vaccine market mainly due to recent additions to the national immunization schedule, but data on post-marketing surveillance for adverse events following immunization (AEFI) are sparse. To compare reporting rates for various categories of AEFI from China with other routine post-marketing surveillance programs internationally. Systematic review of published studies reporting rates of AEFI by vaccine, category of reaction and age from post-marketing surveillance systems in English and Chinese languages. Overall AEFI reporting rates (all vaccines, all ages) in Chinese studies were consistent with those from similar international studies elsewhere, but there was substantial heterogeneity in regional reporting rates in China (range 2.3-37.8/100,000 doses). The highest AEFI reporting rates were for diphtheria-tetanus-pertussis whole-cell (DTwP) and acellular (DTaP) vaccines (range 3.3-181.1/100,000 doses for DTwP; range 3.5-92.6/100,000 doses for DTaP), with higher median rates for DTwP than DTaP, and higher than expected rates for DTaP vaccine. Similar higher rates for DTwP and DTaP containing vaccines, and relatively lower rates for vaccines against hepatitis B virus, poliovirus, and Japanese encephalitis virus were found in China and elsewhere in the world. Overall AEFI reporting rates in China were consistent with similar post-marketing surveillance systems in other countries. Sources of regional heterogeneity in AEFI reporting rates, and their relationships to differing vaccine manufacturers versus differing surveillance practices, require further exploration. Copyright © 2012 Elsevier Ltd. All rights reserved.

  3. Regulatory requirements for biocides on the market in the European Union according to Directive 98/8/EC.

    Science.gov (United States)

    Rasmussen, K; Chemin, P; Haastrup, P

    1999-06-30

    In early 1998, the European Commission and Parliament adopted a new Directive concerning the placing on the market of biocidal products. The Directive is to be implemented in the member states by May 2000. The member states are currently concerned with the national implementation into legislation whereas the Commission is setting up the proposal for a review programme for the existing active substances and the products in which they are used. This paper describes the effort currently undertaken (up to the end of December 1998) to define the procedures to be used and characterise the substances covered. Copyright 1999 Elsevier Science B.V.

  4. Rent distribution effect of a price reduction in the Dutch gas transport market. A scenario analysis of regulatory policy, market form and rent allocation

    International Nuclear Information System (INIS)

    Van Witteloostuijn, A.; Brakman, S.; Van Marrewijk, C.

    2005-09-01

    As part of the larger energy market deregulation program, the Dutch Office of Energy Regulation (DTe) has developed the habit to force the Dutch gas transport enterprise (Gas Transport Services GTS) to lower its prices. In this report, we simulate the welfare effects of a five per cent transport price reduction. DTe's key argument is that lower gas transport prices will benefit the end-user. Indeed, that might well be the case. However, at least three observations complicate matters substantially: Observation 1: government ownership. GTS is government -owned, and the dominant shipper (Gasunie Trade and Supply) is partly so (50 %). Hence, lost revenues from the gas transport business will all emerge at the debit side of the government's budget, and part of the shippers' rent returns in the government's pockets. Observation 2: imperfect competition. Firms enter into the competitive game to make profits. Shippers are not different. So, apart from in the extreme case of perfect competition (or, more generally, perfect contestability), part of the rents will end up in the pockets of the shippers, rather than the endconsumers. Observation 3: rent export. The Netherlands are not an isolated island in the European gas ocean. Not only is the majority of gas transported in the Netherlands exported to foreign end-users, but apart from that have foreign owners a large stake in Dutch shippers. As a result, given the fact that the Dutch industry is not autarktic, part of the rents will always be distributed, or will always 'leak' away, to foreign consumers and shippers (or their shareholders). These three observations together have three important implications. First, state ownership implies that much rent allocation is simply a matter of circulating money from one government sub-budget to the other (Observation 1). Second, given that the industry is imperfectly competitive, part of the rents will not be passed on to the endconsumers (Observation 2). Third, it is unavoidable

  5. The clinical efficacy of a clarithromycin-based regimen for Mycobacterium avium complex disease: A nationwide post-marketing study.

    Science.gov (United States)

    Kadota, Jun-Ichi; Kurashima, Atsuyuki; Suzuki, Katsuhiro

    2017-05-01

    The revised 2007 American Thoracic Society/Infectious Diseases Society of America statement recommend clarithromycin-based combination therapy for treatment of Mycobacterium avium complex lung disease and stipulates approximately 1 year of continuous treatment after bacilli negative conversion. However, supporting data are insufficient. Our objective was to obtain data on the clinical outcome of clarithromycin-based daily regimens by conducting a nationwide retrospective post-marketing study of M. avium complex lung disease. In accordance with the Japanese guidelines, patients were enrolled in this survey according to their chest radiographic findings and microbiologic test results. They were treated with a multidrug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin-based regimen) until bacilli negative conversion, and the treatment was continued for approximately 1 year after the initial conversion. Data were collected before administration, at the time of bacilli negative conversion, at the end of treatment, and at 6 months after the end of treatment. Of the 466 subjects enrolled in the study, 271 patients who received clarithromycin at 800 mg/day underwent evaluation for M. avium complex disease. The final bacilli negative conversion rate in those patients was 94.7%. The bacteriological relapse rate was 5.0% (5/100 patients). Bacteriological relapse was noted in patients treated for less than 15 months after conversion. No life-threatening or serious adverse drug reactions were observed. This study demonstrated that a clarithromycin-based daily regimen can yield a high bacteriological conversion rate in M. avium complex disease. After conversion, treatment for less than 15 months might be insufficient to prevent bacteriological relapse. Copyright © 2017 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  6. Drug-induced lung injury associated with sorafenib: analysis of all-patient post-marketing surveillance in Japan.

    Science.gov (United States)

    Horiuchi-Yamamoto, Yuka; Gemma, Akihiko; Taniguchi, Hiroyuki; Inoue, Yoshikazu; Sakai, Fumikazu; Johkoh, Takeshi; Fujimoto, Kiminori; Kudoh, Shoji

    2013-08-01

    Sorafenib is a multi-kinase inhibitor currently approved in Japan for unresectable and/or metastatic renal cell carcinoma and unresectable hepatocellular carcinoma. Although drug-induced lung injury has recently been the focus of interest in Japanese patients treated with molecular targeting agents, the clinical features of patients receiving sorafenib remain to be completely investigated. All-patient post-marketing surveillance data was obtained within the frame of Special Drug Use Investigation; between April 2008 and March 2011, we summarized the clinical information of 62 cases with drug-induced lung injury among approximately 13,600 sorafenib-treated patients in Japan. In addition, we summarized the results of evaluation by a safety board of Japanese experts in 34 patients in whom pulmonary images were available. For the calculation of reporting frequency, interim results of Special Drug Use Investigation were used. In the sets of completed reports (2,407 in renal cell carcinoma and 647 in hepatocellular carcinoma), the reporting frequency was 0.33 % (8 patients; fatal, 4/8) and 0.62 % (4 patients; fatal, 2/4), respectively. Major clinical symptoms included dyspnea, cough, and fever. Evaluation of the images showed that 18 cases out of 34 patients had a pattern of diffuse alveolar damage. The patients with hepatocellular carcinoma showed a greater incidence and earlier onset of lung injury than those with renal cell carcinoma. Although the overall reporting frequency of sorafenib-induced lung injury is not considered high, the radiological diffuse alveolar damage pattern led to a fatal outcome. Therefore, early recognition of sorafenib-induced lung injury is crucial for physicians and patients.

  7. Clinical significance and epidemiologic analyses of Mycobacterium avium and Mycobacterium intracellulare lung disease from post-marketing surveillance.

    Science.gov (United States)

    Suzuki, Katsuhiro; Kurashima, Atsuyuki; Tatsuno, Kinji; Kadota, Jun-Ichi

    2018-01-01

    In Japan, nontuberculous mycobacterial lung disease is mostly attributable to Mycobacterium avium complex (MAC), i.e., M. avium or M. intracellulare. However, clinical features of the disease caused by these two pathogens have not been studied sufficiently yet. A post-marketing survey of clarithromycin was performed at 130 facilities across Japan. The data on patients with M. avium infection and patients with M. intracellulare infection were selected from this survey for comparison of background variables and clinical features of the two pathogens. Among the patients analyzed (n = 368), 67.4% had M. avium infection and 32.6% had M. intracellulare infection. Stratified analysis revealed no significant differences between the ratio of the two pathogens based on gender, disease type, complication, past medical history, or smoking history. However, the percentage of patients with M. intracellulare infection was significantly higher among those with underlying lung disease than among those without lung disease (p = 0.0217). The percentage of patients with M. intracellulare infection rose significantly with age (p = 0.0296). This age-related change was more significant in women (p = 0.0018). When district-wise analysis was performed for Japan, the percentage of M. intracellulare infection was higher in the Chugoku/Shikoku and Kyushu districts whereas the percentage of M. avium infection was higher in the other districts. This survey revealed some differences in the clinical and epidemiologic features of M. avium and M. intracellulare infection. The significant predominance of M. avium infection among relatively young women is suggestive of an increase in the M. avium/M. intracellulare infection ratio among women in the future. Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  8. Safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension: Japanese post-marketing surveillance data.

    Science.gov (United States)

    Yamazaki, Hiroyoshi; Kobayashi, Noriko; Taketsuna, Masanori; Tajima, Koyuki; Murakami, Masahiro

    2017-05-01

    To evaluate the long-term safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. This prospective, multicenter, noninterventional, post-marketing surveillance included patients with PAH who were observed for up to 2 years after initiation of tadalafil. Safety was assessed by analyzing the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs). Effectiveness measurements included the assessment of the change in World Health Organization (WHO) functional classification of PAH, 6-minute walk test, cardiac catheterization, and echocardiography. Among 1676 patients analyzed for safety, the overall incidence of ADRs was 31.2%. The common ADRs (≥1.0%) were headache (7.0%), diarrhea (1.9%), platelet count decreased (1.8%), anemia, epistaxis, and nausea (1.6% each), flushing (1.3%), hepatic function abnormal (1.1%), hot flush, and myalgia (1.0% each). The common SADRs (≥0.3%) were cardiac failure (0.7%), interstitial lung disease, worsening of PAH, and platelet count decreased (0.3% each). Among 1556 patients analyzed for effectiveness, the percentages of patients with improvement of WHO functional class at 3 months, 1 year, and 2 years after the initiation of tadalafil, and last observation were 17.1%, 24.8%, 28.9%, and 22.5%, respectively. At all observation points (except pulmonary regurgitation pressure gradient at end diastole at 3 months), the mean 6-minute walk distance, cardiac catheterization, and echocardiogram measurements showed statistically significant improvement. This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in patients with PAH in Japan.

  9. Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study.

    Science.gov (United States)

    Sun, Jing; Yuan, Yao-Zong; Holtmann, Gerald

    2011-12-01

    Prokinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials. The objective of this study was to assess the effectiveness and safety of itopride in the management of FD. This was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%. In total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p Itopride was an effective and well tolerated drug in the management of FD in this patient population.

  10. Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations.

    Science.gov (United States)

    Wang, Can; Shi, Qing-Ping; Ding, Feng; Jiang, Xiao-Dong; Tang, Wei; Yu, Mei-Ling; Zhu, Jian-Hua

    2018-01-01

    To evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening. This study used a prospective, nested case-control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR) of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening. The results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674), and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760) when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single dose, and indicated vs off-label use. Risk factors for adverse reaction following the use of Shuxuening injection in patients are associated with a single dose, vehicle, type of disease, and combination with potassium aspartate, atorvastatin calcium, Shengmai injection, injection with pantoprazole sodium, and other drugs. Physicians should be careful to follow guidelines when administering this drug. We further propose that the unique methodology

  11. Safety and Effectiveness of Mirabegron in Patients with Overactive Bladder Aged ≥75 Years: Analysis of a Japanese Post-Marketing Study.

    Science.gov (United States)

    Yoshida, Masaki; Nozawa, Yumiko; Kato, Daisuke; Tabuchi, Hiromi; Kuroishi, Kentarou

    2017-09-12

    A 12-week post-marketing study was conducted to provide real-world data on Japanese patients with overactive bladder (OAB) initiating treatment with mirabegron. This post-hoc analysis focused on safety and effectiveness of mirabegron in patients aged ≥75 versus Similar changes were observed for I-PSS QoL in both groups. In a real-world clinical setting, mirabegron was well-tolerated and effective in patients aged ≥75 and <75 years. © 2017 John Wiley & Sons Australia, Ltd.

  12. Post-Purchase Evaluation in the Smartphone Market: An Investigation into Cognitive Dissonance among iPhone and Other Smartphone Brand Owners

    OpenAIRE

    Kraappa, Anna

    2011-01-01

    Purpose The main objective was to investigate whether iPhone owners experienced less cognitive post-purchase dissonance than other brand owners and was this due to the marketing communications efforts of Apple Inc., from hereon called Apple. Finally, the influence of Web 2.0 in the process of post-purchase evaluation was examined. Web 2.0 is a version of the Internet and it encourages towards user engagement on websites such as Facebook. Methodology A critical review of the litera...

  13. Offshore wind power. Market opportunities for the Norwegian supply industry, and regulatory framework needed to realize these opportunities

    Energy Technology Data Exchange (ETDEWEB)

    Volden, G.; Bull-Berg, H.; Skjeret, F.; Finne, H.; Hofmann, M.

    2010-07-01

    Full text: Offshore wind power has received much attention these last few years, from governments, NGOs as well as energy companies. There are still huge technological challenges to overcome, especially concerning floating constructions on deep water, but offshore wind has a potential to become an important energy source in the future. The main objective of our study was to build more knowledge about market opportunities for the Norwegian supply industry, most of which is closely related to offshore oil and gas activities. We started by mapping and quantifying the parts of the supply industry that could be relevant to offshore wind, which is actually most of it. Then, through interviews and questionnaires, we asked potential suppliers about their attitude and strategies towards offshore wind. An over-whelming majority was optimistic about future markets internationally, whereas there was less belief in large-scale power production on the Norwegian shelf. Suppliers do not necessarily find the lack of a Norwegian 'home market' to be a barrier. However many of them expressed that the risk is high and it may be crucial to establish a national demo program, for supplier to test new technological solutions at low cost, gain references and develop industrial relations with other suppliers. We argue that being part of an industrial cluster may be a success criterion within offshore wind. By using Michael Porter's 'Diamond Model' we analyse Norway's inherent competitiveness as a potential host for an offshore wind cluster - with or without energy producers. Norway's most important advantage is the existing industrial environment, with a strong maritime sector and engineering companies with special competence in floating and fixed installations for the oil industry. Norway also has disadvantages; such as lack of traditions within wind power and wind turbine manufacturing, as well as high salaries and lack of engineers. So far it is also

  14. Dissecting the expression relationships between RNA-binding proteins and their cognate targets in eukaryotic post-transcriptional regulatory networks

    Science.gov (United States)

    Nishtala, Sneha; Neelamraju, Yaseswini; Janga, Sarath Chandra

    2016-05-01

    RNA-binding proteins (RBPs) are pivotal in orchestrating several steps in the metabolism of RNA in eukaryotes thereby controlling an extensive network of RBP-RNA interactions. Here, we employed CLIP (cross-linking immunoprecipitation)-seq datasets for 60 human RBPs and RIP-ChIP (RNP immunoprecipitation-microarray) data for 69 yeast RBPs to construct a network of genome-wide RBP- target RNA interactions for each RBP. We show in humans that majority (~78%) of the RBPs are strongly associated with their target transcripts at transcript level while ~95% of the studied RBPs were also found to be strongly associated with expression levels of target transcripts when protein expression levels of RBPs were employed. At transcript level, RBP - RNA interaction data for the yeast genome, exhibited a strong association for 63% of the RBPs, confirming the association to be conserved across large phylogenetic distances. Analysis to uncover the features contributing to these associations revealed the number of target transcripts and length of the selected protein-coding transcript of an RBP at the transcript level while intensity of the CLIP signal, number of RNA-Binding domains, location of the binding site on the transcript, to be significant at the protein level. Our analysis will contribute to improved modelling and prediction of post-transcriptional networks.

  15. Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market.

    Science.gov (United States)

    Sillo, Hiiti B; Masota, Nelson E; Kisoma, Sunday; Rago, Lembit; Mgoyela, Veronica; Kaale, Eliangiringa A

    2018-01-01

    the medicines, and directions regarding overdose ranked the least in conformance with conformity ranging from 13.1-52.5%. The parameter with the lowest observed percentage conformity among the branded products scored 50% as compared to 10.8% among the generic products. Moreover, there was no significant difference (Pinformation requirements. Our study revealed the existence of a significant number of medicinal products circulating on the markets of EAC Partner States without necessary compliance with all product information requirements. We therefore recommend that NMRAs ensure thorough pre-market assessment of product information as well as strengthening their post marketing surveillance to ensure that medicines circulating on the market comply to medicines information requirements at all times. Emphasis should also be given to manufacturers on the importance of inclusion of appropriate and adequate product information for the safety of patients, including advocating for inclusion of patient-friendly and easy to understand medicines information.

  16. Post operation: The changing characteristics of nuclear fuel cycle costs

    International Nuclear Information System (INIS)

    Frank, F.J.

    1986-01-01

    Fundamental changes have occurred in the nuclear fuel cycle. These changes forged by market forces, legislative action, and regulatory climate appear to be a long term characteristic of the nuclear fuel cycle. The nature of these changes and the resulting emerging importance of post-operation and its impact on fuel cycle costs are examined

  17. [Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming; Fu, Yingkun

    2011-10-01

    Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.

  18. Highlights of the EPA innovative regulatory strategies workshop: Market-based incentives and other innovations for air pollution control. Summary of workshop discussion sessions. Held in Washington, DC on January 15-17, 1992

    International Nuclear Information System (INIS)

    1992-06-01

    The Clean Air Act Amendments of 1990 allow, and in some cases require, States to adopt market-based strategies or other innovative types of air pollution control. The U.S. Environmental Protection Agency's (EPA's) innovative regulatory strategies program seeks to encourage and facilitate, as appropriate, the development, demonstration, and implementation of a wide range of innovative regulatory air pollution programs, including market-based, informational, and pollution prevention approaches. The 3-day national workshop, attended by over two hundred people from Federal, State, and local agencies, industry, environmental and public interest groups, and the academic community highlighted issues associated with a variety of innovative, market-based strategies which are currently being developed or used by State and local authorities around the country

  19. The Internationalization and Market Competition of Tsai Yueh-Hsun’s Post-Confucian TV Drama and Films in East Asia

    OpenAIRE

    Jocelyn Yi-Hsuan Lai

    2018-01-01

    This essay investigates the East Asia-oriented TV and film productions of Taiwanese producer-director Tsai Yueh-hsun. His productions have made wide use of the transnational bankability of Taiwanese TV stars. Set in nationally non-specific urban societies, they are categorized as post-Confucian TV dramas, adopting liberal Western values and presenting problems in the authoritative patriarchal culture of the modern yet Confucian East Asia. They have competed in this market with neo-Confucian K...

  20. Progress on mobility and instability of research personnel in Japan: scientometrics on a job-posting database for monitoring the academic job market

    Energy Technology Data Exchange (ETDEWEB)

    Kawashima, H.; Yamashita, Y.

    2016-07-01

    This study has two purposes. The first purpose is to extract statistics from a database of jobposting cards, previously little-used as a data source, to assess the academic job market. The second purpose is to connect statistics on the academic job market with monitoring of indicators of policy progress related to the mobility and instability of research personnel. The data source used in this study is a job-posting database named JREC-IN Portal, which is the de facto standard for academic job seeking in Japan. The present results show a growing proportion of fixed-term researchers in the Japanese academic job market and that job information is increasingly diverse. (Author)

  1. The Internationalization and Market Competition of Tsai Yueh-Hsun’s Post-Confucian TV Drama and Films in East Asia

    Directory of Open Access Journals (Sweden)

    Jocelyn Yi-Hsuan Lai

    2018-04-01

    Full Text Available This essay investigates the East Asia-oriented TV and film productions of Taiwanese producer-director Tsai Yueh-hsun. His productions have made wide use of the transnational bankability of Taiwanese TV stars. Set in nationally non-specific urban societies, they are categorized as post-Confucian TV dramas, adopting liberal Western values and presenting problems in the authoritative patriarchal culture of the modern yet Confucian East Asia. They have competed in this market with neo-Confucian Korean and mainland Chinese TV dramas that follow Confucian patriarchal values. His productions in the 2000s entered many East Asian markets, including Southeast Asian countries, Japan, and mainland China, with the latter airing censored versions. In the 2010s, his productions have prioritized the rapidly increasing mainland Chinese market among all East Asian markets and adopted Taiwanese-mainland Chinese cooperation. The productions maintain the post-Confucian style of presentation, but remove the political viewpoint commonly perceived in Taiwan. Confronted with Taiwanese skepticism toward the Taiwanese-mainland Chinese cooperation, Tsai argues that this strategy will contribute to the development of Taiwan’s film and TV industry. The presentation of Taiwan’s modern places in the productions will help promote its tourism.

  2. French regulatory requirements for the occupational radiation protection in severe accident situations and post-accident recovery

    International Nuclear Information System (INIS)

    Couasnon, Olivier

    2014-01-01

    Workers of the concerned company and other persons and teams called 'intervention personnel' (specialized firemen, first aider, etc.) are to be involved in radiological emergency situations. Radiation protection provisions for workers and for intervention personnel complement one another because they cover persons with different statutes (workers under the responsibility of an employer and persons acting within the framework of agreements with the public authorities or within the framework of the requisitions). Work or operations exposing workers to ionizing radiation in radiological emergency situations can be assigned only to workers satisfying all of the following conditions: classification in category A worker; free of any medical unfitness; on a list drawn up in advance for this purpose; having received appropriate information on the risks and the precautions to take during the work or the operation; not having received, during the preceding twelve months, a dose greater than one of the annual limit values for exposures subject to special authorization. In addition, the worker must be a volunteer to carry out the work or the operations concerned in radiological emergency situations and have individual dosimetry means appropriate for the situation. Intervention personnel are possibly composed of personnel from responding organizations, such as police officers, fire-fighters, medical personnel, drivers and crews of evacuation vehicles, or of workers employed by the head of the damaged plant. In order to determine their selection, training and medical and radiological monitoring conditions, intervention personnel are classified into two groups: personnel forming the special technical, medical and health intervention teams readied in advance to deal with radiological emergency situations and persons not belonging to special teams but intervening as part of the tasks within the scope of their competence. In case of an existing exposure situation (post

  3. Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence.

    Science.gov (United States)

    Kuwayama, Yasuaki; Hashimoto, Masako; Kakegawa, Reiko; Nomura, Akio; Shimada, Fumiki

    2017-06-01

    The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with

  4. A Post-marketing Surveillance Study of Chronic Wounds Treated With a Native Collagen Calcium Alginate Dressing.

    Science.gov (United States)

    Sabo, Matthew; Le, Lam; Yaakov, Raphael A; Carter, Marissa; Serena, Thomas E

    2018-04-01

    Chronic wounds (ie, wounds that fail to progress through a normal, orderly, timely sequence of repair) continue to pose significant clinical and economic burdens. A prospective, descriptive, 3-week post-marketing surveillance study was conducted across 3 wound care centers in the United States to evaluate the effectiveness of a collagen calcium alginate dressing on chronic wounds in conjunction with standard care (SC) practices (eg, offloading, debridement, compression) to support healing. Eligible participants had to be >18 years of age, have at least 1 chronic wound, and no known sensitivity to collagen. Demographic characteristics were recorded at the screening visit on case report forms. At each visit, wound-related pain was assessed using the Visual Analog Scale along with wound characteristics including size (using digital planimetry), wound exudate (minimal, moderate, heavy), and odor (none, mild). Participants were monitored for adverse events as well as infection based on signs and symptoms in and around the local wound bed, the deeper structures, and the surrounding skin. An intention-to-treat approach was used for all analyses. If an observation was missing, the last observation carried forward principle was used. For wounds that healed, pain and exudate were set to 0 (no pain/exudate) at visit 4. Descriptive, paired t tests and the Wilcoxon signed rank test were used to analyze the data. Of the 31 participants (15 men, 16 women, mean age 66.6 years), most (13, 42%) had a diabetic foot ulcer or venous leg ulcer (10, 32%); median duration of all wounds was 148 days. Thirty (30) patients completed the study. The mean number of comorbidities was 10.6 ± 6.3, and patients used a mean of 9.3 ± 5.64 prescription or over-the-counter medications. For all wounds combined, mean wound area was 4.8 ± 8.38 cm2 at baseline. At week 3, a decrease in wound area of 38.1% was noted (median: 45% ± 42.54; P = .006); 3 wounds healed completely. The change in wound exudate

  5. Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study – PRIME study

    Directory of Open Access Journals (Sweden)

    Shah K

    2017-05-01

    Full Text Available Kshitij Shah,1 Omvijay B Chaudhari,2 Palash Gupta,3 R Hom Chaudhuri,4 Ranjan Kamilya,5 Shreedhar S Kulkarni,6 S Subbaiah,7 Zubair H Sorathia,8 Gauri Billa9 1MS Orthopedic, Prime Hospital, Andheri (West, 2Vatsalya Nursing Home, Kalyan (West, Mumbai, 3Dr. Palash Gupta Clinic, Rohini, New Delhi, 4Homchaudhuri’s Clinic, 5Apollo Gleneagles Hospital, Kolkata, West Bengal, 6Amrit Clinic, Matunga, Mumbai, 7Subbaiah’s Clinic, West Mambalam, Chennai, 8Medicare Hospital, Marol, Andheri East, 9Medical Services, Abbott Healthcare Pvt. Ltd, Mulund (West, Mumbai, Maharashtra, India Objective: To assess the effectiveness, overall tolerability, and gastrointestinal (GI tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg] in symptomatic treatment of severe acute pain in physician’s routine clinical practice. Materials and methods: In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18–60 years with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at baseline, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. Results: A total of 351 patients (mean age 44.2 years; male 43%; female 57% were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (p<0.0001. The number of patients with severe intensity of pain reduced from 100% at baseline to 18.3% at day 2 and 6.96% at day 5. According to the patient assessment, 68.36% of patients reported tolerability as “very good to good”, whereas according to physician’s assessment, “very good to good” tolerability was reported in 68.27% of patients. Five (1.43 % patients discontinued the study because of adverse drug reaction. Five patients developed nine GI-related events of moderate intensity. Two patients

  6. As to achieve regulatory action, regulatory approaches

    International Nuclear Information System (INIS)

    Cid, R.; Encinas, D.

    2014-01-01

    The achievement of the effectiveness in the performance of a nuclear regulatory body has been a permanent challenge in the recent history of nuclear regulation. In the post-Fukushima era this challenge is even more important. This article addresses the subject from two complementary points of view: the characteristics of an effective regulatory body and the regulatory approaches. This work is based on the most recent studies carried out by the Committee on Nuclear Regulatory Activities, CNRA (OECD/NEA), as well as on the experience of the Consejo de Seguridad Nuclear, CSN, the Spanish regulatory body. Rafael Cid is the representative of CSN in these project: Diego Encinas has participated in the study on regulatory approaches. (Author)

  7. [Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

    Science.gov (United States)

    Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

    2012-03-01

    Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

  8. Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings.

    Science.gov (United States)

    Chahal, Harinder Singh; Kashfipour, Farrah; Susko, Matt; Feachem, Neelam Sekhri; Boyle, Colin

    2016-05-01

    Medicines Regulatory Authorities (MRAs) are an essential part of national health systems and are charged with protecting and promoting public health through regulation of medicines. However, MRAs in resource-constrained settings often struggle to provide effective oversight of market entry and use of health commodities. This paper proposes a regulatory value chain model (RVCM) that policymakers and regulators can use as a conceptual framework to guide investments aimed at strengthening regulatory systems. The RVCM incorporates nine core functions of MRAs into five modules: (i) clear guidelines and requirements; (ii) control of clinical trials; (iii) market authorization of medical products; (iv) pre-market quality control; and (v) post-market activities. Application of the RVCM allows national stakeholders to identify and prioritize investments according to where they can add the most value to the regulatory process. Depending on the economy, capacity, and needs of a country, some functions can be elevated to a regional or supranational level, while others can be maintained at the national level. In contrast to a "one size fits all" approach to regulation in which each country manages the full regulatory process at the national level, the RVCM encourages leveraging the expertise and capabilities of other MRAs where shared processes strengthen regulation. This value chain approach provides a framework for policymakers to maximize investment impact while striving to reach the goal of safe, affordable, and rapidly accessible medicines for all.

  9. Hospital cost and quality performance in relation to market forces: an examination of U.S. community hospitals in the "post-managed care era".

    Science.gov (United States)

    Jiang, H Joanna; Friedman, Bernard; Jiang, Shenyi

    2013-03-01

    Managed care substantially transformed the U.S. healthcare sector in the last two decades of the twentieth century, injecting price competition among hospitals for the first time in history. However, total HMO enrollment has declined since 2000. This study addresses whether managed care and hospital competition continued to show positive effects on hospital cost and quality performance in the "post-managed care era." Using data for 1,521 urban hospitals drawn from the Healthcare Cost and Utilization Project, we examined hospital cost per stay and mortality rate in relation to HMO penetration and hospital competition between 2001 and 2005, controlling for patient, hospital, and other market characteristics. Regression analyses were employed to examine both cross-sectional and longitudinal variation in hospital performance. We found that in markets with high HMO penetration, increase in hospital competition over time was associated with decrease in mortality but no change in cost. In markets without high HMO penetration, increase in hospital competition was associated with increase in cost but no change in mortality. Overall, hospitals in high HMO penetration markets consistently showed lower average costs, and hospitals in markets with high hospital competition consistently showed lower mortality rates. Hospitals in markets with high HMO penetration also showed lower mortality rates in 2005 with no such difference found in 2001. Our findings suggest that while managed care may have lost its strength in slowing hospital cost growth, differences in average hospital cost associated with different levels of HMO penetration across markets still persist. Furthermore, these health plans appear to put quality of care on a higher priority than before.

  10. Scientific, economic, regulatory, and ethical challenges of bringing science-based pediatric nutrition products to the U.S. market and ensuring their availability for patients.

    Science.gov (United States)

    Merritt, Russell J; Goldsmith, Arthur H

    2014-11-01

    Many nutrition products and related drugs are unavailable or not consistently available to clinicians despite a body of clinical data and experience supporting their use. Many of these can be related to drug shortages that have increased since 2009. In addition, there are potentially useful products that are not approved for a specific use or are no longer being manufactured. This review broadly examines the product availability gap from the perspectives of a clinician/former nutrition industry medical director and an economist. The process of pediatric nutrition product and related drug innovation, as well as its drivers and the steps involved in bringing a product to market, is first described. This is followed by an assessment of factors influencing product availability beyond the innovation process, including regulatory issues, manufacturing compliance, purchasing practices, and other factors related to drug and nutrition product pricing and reimbursement. Three pediatric case examples are reviewed and placed in the context of the prior review. Last, recent and future possible steps toward closing the product availability gap are discussed. © 2014 American Society for Parenteral and Enteral Nutrition.

  11. Marketing marketing

    NARCIS (Netherlands)

    dr. Karel Jan van Alsem

    2013-01-01

    In deze installatierede betoogt Karel Jan Alsem dat marketing een grotere strategische rol in organisaties zou moeten krijgen. Want marketing is bij uitstek de verbinding tussen klantwensen en het DNA van een organisatie. Doordat merken gemiddeld voor mensen niet heel belangrijk zijn, is goede

  12. Disclosure as a regulatory tool

    DEFF Research Database (Denmark)

    Sørensen, Karsten Engsig

    2006-01-01

    The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law.......The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law....

  13. LES AMIS D'ESCOFFIER AND THE POST-DEPRESSION LABOR MARKET FOR CHEFS DE CUISINE IN AMERICA

    Directory of Open Access Journals (Sweden)

    Martin T. Ollif

    2001-01-01

    Full Text Available This essay uses a cultural studies approach to analyze the effort of the gourmet society Les Amis d'Escoffier to re-create the niche market for chefs’ services in the waning years of the Great Depression. It examines the depressed labor market for chefs after 1912 as well as aspects of the chefs’ culture that informed the unusual rules and rituals Les Amis used to educate wealthy men in gourmandaise. It concludes that, regardless of how successful the society was in its original goal, culture as well as functional response shaped the chefs’ remedy to their labor market problems.

  14. Market, Regulation, Market, Regulation

    DEFF Research Database (Denmark)

    Frankel, Christian; Galland, Jean-Pierre

    2015-01-01

    barriers to trade in Europe, realized the free movement of products by organizing progressively several orders of markets and regulation. Based on historical and institutional documents, on technical publications, and on interviews, this article relates how the European Commission and the Member States had......This paper focuses on the European Regulatory system which was settled both for opening the Single Market for products and ensuring the consumers' safety. It claims that the New Approach and Standardization, and the Global Approach to conformity assessment, which suppressed the last technical...... alternatively recourse to markets and to regulations, at the three main levels of the New Approach Directives implementation. The article focuses also more specifically on the Medical Devices sector, not only because this New Approach sector has long been controversial in Europe, and has recently been concerned...

  15. Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

    Science.gov (United States)

    Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

    2017-08-01

    This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.

  16. [Post-marketing surveillance of antibacterial activities of cefozopran against various clinical isolates--I. Gram-positive bacteria].

    Science.gov (United States)

    Igari, Jun; Oguri, Toyoko; Hiramatsu, Nobuyoshi; Akiyama, Kazumitsu; Koyama, Tsuneo

    2003-10-01

    As a post-marketing surveillance, the in vitro antibacterial activities of cefozopran (CZOP), an agent of cephems, against various clinical isolates were yearly evaluated and compared with those of other cephems, oxacephems, penicillins, and carbapenems. Changes in the bacterial susceptibility for CZOP were also evaluated with the resistance ratio calculated with breakpoint MIC. Sixteen species (2,363 strains) of Gram-positive bacteria were isolated from the clinical materials annually collected from 1996 to 2001, and consisted of methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus epidermidis (MSSE), methicillin-resistant Staphylococcus epidermidis (MRSE), Staphylococcus haemolyticus, Staphylococcus saprophyticus, Enterococcus faecalis, Enterococcus faecium, Enterococcus avium, Streptococcus pyogenes, Streptococcus agalactiae, penicillin-susceptible Streptococcus pneumoniae (PSSP), penicillin-intermediate resistant S. pneumoniae (PISP), penicillin-resistant S. pneumoniae (PRSP), Streptococcus milleri group and Peptostreptococcus spp. The antibacterial activity of CZOP either against MSSA or MSSE was preferable (MIC90: 2 or 0.5 micrograms/mL) and comparable to those of other cephems. CZOP was also effective on MRSE (MIC90: 16 micrograms/mL) but not on MRSA. CZOP and other cephems had low antibacterial activity against S. haemolyticus (MIC90: 64 micrograms/mL). The antibacterial activity of CZOP against S. saprophyticus was comparable to or higher than those of other cephems, but the MIC90 of CZOP in 2001 was higher than those in 1996-2000 (32 vs 1-2 micrograms/mL). The antibacterial activity of CZOP against E. faecalis was comparable to that of cefpirome (CPR; MIC90: 16 micrograms/mL) and higher than those of other cephems. No antibacterial activity of CZOP against E. faecium and E. avium was observed, like other drugs. The antibacterial activity of CZOP against S. pyogenes

  17. [Post-marketing surveillance of antibacterial activities of cefozopran against various clinical isolates--II. Gram-negative bacteria].

    Science.gov (United States)

    Igari, Jun; Oguri, Toyoko; Hiramatsu, Nobuyoshi; Akiyama, Kazumitsu; Koyama, Tsuneo

    2003-10-01

    As a post-marketing surveillance, the in vitro antibacterial activities of cefozopran (CZOP), an agent of cephems, against various clinical isolates were yearly evaluated and compared with those of other cephems, oxacephems, carbapenems, monobactams, and penicillins. Changes in CZOP susceptibility among bacteria were also evaluated with the bacterial resistance ratio calculated from the breakpoint MIC. Twenty-five species (4,154 strains) of Gram-negative bacteria were isolated from the clinical materials annually collected from 1996 to 2001, and consisted of Moraxella (Branhamella) catarrhalis, Haemophilus influenzae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae, Enterobacter aerogenes, Serratia marcescens, Serratia liquefaciens, Citrobacter freundii, Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia spp., Pseudomonas aeruginosa, Pseudomonas fluorescens, Pseudomonas putida, Acinetobacter baumannii, Acinetobacter Iwoffii, Burkholderia cepacia, Stenotrophomonas maltophilia, Bacteroides fragilis group, and Prevotella/Porphyromonas. CZOP preserved its antibacterial activity against M. (B.) catarrhalis (MIC90: 4 micrograms/mL) and showed comparable activity to carbapenems against H. influenzae (MIC90: 1 microgram/mL). The antibacterial activity of CZOP against E. coli was preferable (MIC90: 0.125 microgram/mL) and comparable to those of cefpirome (CPR), cefepime (CFPM), and imipenem (IPM). The MIC90 of CZOP against K. pneumoniae and K. oxytoca was 1 and 0.25 microgram/mL, respectively. The MIC90 of CZOP against E. cloacae increased during 6 years (32 to 128 micrograms/mL). The antibacterial activity of CZOP against E. aerogenes was preferable (MIC90: 1 microgram/mL). The antibacterial activities of CZOP against S. marcescens and S. liquefaciens were relatively potent (MIC90: 0.5 and 0.25 microgram/mL) and comparable to those of CPR, CFPM, and carumonam. CZOP preserved comparable antibacterial

  18. Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

    Science.gov (United States)

    Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

    2015-04-01

    The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. Published by Elsevier Inc.

  19. Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: a case study of breast cancer screening and diagnostic devices.

    Science.gov (United States)

    Vreugdenburg, T D; Willis, C D; Mundy, L; Hiller, J E

    2013-01-01

    While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence. © 2011 The Authors; Internal Medicine Journal © 2011 Royal Australasian College of Physicians.

  20. Hepatitis B virus nuclear export elements: RNA stem-loop α and β, key parts of the HBV post-transcriptional regulatory element.

    Science.gov (United States)

    Lim, Chun Shen; Brown, Chris M

    2016-09-01

    Many viruses contain RNA elements that modulate splicing and/or promote nuclear export of their RNAs. The RNAs of the major human pathogen, hepatitis B virus (HBV) contain a large (~600 bases) composite cis-acting 'post-transcriptional regulatory element' (PRE). This element promotes expression from these naturally intronless transcripts. Indeed, the related woodchuck hepadnavirus PRE (WPRE) is used to enhance expression in gene therapy and other expression vectors. These PRE are likely to act through a combination of mechanisms, including promotion of RNA nuclear export. Functional components of both the HBV PRE and WPRE are 2 conserved RNA cis-acting stem-loop (SL) structures, SLα and SLβ. They are within the coding regions of polymerase (P) gene, and both P and X genes, respectively. Based on previous studies using mutagenesis and/or nuclear magnetic resonance (NMR), here we propose 2 covariance models for SLα and SLβ. The model for the 30-nucleotide SLα contains a G-bulge and a CNGG(U) apical loop of which the first and the fourth loop residues form a CG pair and the fifth loop residue is bulged out, as observed in the NMR structure. The model for the 23-nucleotide SLβ contains a 7-base-pair stem and a 9-nucleotide loop. Comparison of the models with other RNA structural elements, as well as similarity searches of human transcriptome and viral genomes demonstrate that SLα and SLβ are specific to HBV transcripts. However, they are well conserved among the hepadnaviruses of non-human primates, the woodchuck and ground squirrel.