Sample records for fda advisory briefing
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2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...
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21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda...
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76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment
2011-07-29
.... FDA-2010-N-0002] Advisory Committee; Medical Imaging Drugs Advisory Committee; Re- Establishment... (FDA) is announcing the re- establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging...
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FDA advisory committees meet January 26 on Salk HIV-1 immunogen.
1995-01-06
Two advisory committees of the Food and Drug Administration (FDA) will meet to consider future trials of the HIV-1 immunogen developed by Dr. Jonas Salk. The Immune Response Corporation has already conducted several studies of the immunogen, and has found improvement in various immunological and other blood tests, and no adverse effects. However, the studies have not been large enough to show conclusively that the treatment has clinical benefit in delaying disease progression. The new, larger trials are intended to demonstrate a delay in disease progression and validate the use of blood-test markers of disease progression for studying an immune-based treatment.
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78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination
2013-11-22
.... FDA-2013-N-1380] Advisory Committee; Veterinary Medicine Advisory Committee; Termination AGENCY: Food... announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of standing advisory committees. DATES: This rule is...
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76 FR 5380 - Advisory Committees; Filing of Closed Meeting Reports
2011-01-31
...] Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION... Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA...), FDA has filed with the Library of Congress the annual reports for the following FDA advisory...
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77 FR 64524 - Arthritis Advisory Committee; Notice of Meeting
2012-10-22
...), submitted by Hemispherx Biopharma, Inc., for the treatment of patients with chronic fatigue syndrome. FDA... scroll down to the appropriate advisory committee meeting link, or call the advisory committee... available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm . Scroll down to the appropriate...
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75 FR 57279 - Risk Communication Advisory Committee; Notice of Meeting
2010-09-20
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Committee will hear and discuss developments in FDA's ongoing communications programs, such as FDA's...
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75 FR 55805 - Arthritis Advisory Committee; Notice of Meeting
2010-09-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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76 FR 42715 - Arthritis Advisory Committee; Notice of Meeting
2011-07-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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77 FR 13611 - Arthritis Advisory Committee; Notice of Meeting
2012-03-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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77 FR 1697 - Arthritis Advisory Committee; Notice of Meeting
2012-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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78 FR 33423 - Arthritis Advisory Committee; Notice of Meeting
2013-06-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...
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76 FR 52334 - Arthritis Advisory Committee; Notice of Postponement of Meeting
2011-08-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is postponing the Arthritis Advisory...
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78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2013-04-05
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to...
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76 FR 44017 - Risk Communication Advisory Committee; Notice of Meeting
2011-07-22
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... and former members of the Risk Communication Advisory Committee. FDA intends to make background...
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Real-World Evidence, Public Participation, and the FDA.
Schwartz, Jason L
2017-11-01
For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.
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75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation
2010-12-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee scheduled for February 9, 2011, is...
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77 FR 63839 - Oncologic Drugs Advisory Committee; Cancellation
2012-10-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee Meeting scheduled for November 8, 2012, is...
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75 FR 8377 - Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice
2010-02-24
...] Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS... of a meeting of the Pulmonary-Allergy Drugs Advisory Committee. This meeting was announced in the... February 2, 2010, FDA announced that a meeting of the Pulmonary-Allergy Drugs Advisory Committee would be...
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76 FR 78931 - Advisory Committees; Tentative Schedule of Meetings for 2012
2011-12-20
..., April 30, May 1, August 16-17, November 1-2. Science Board to FDA January 6, May 2, October 3. CENTER... Date(s), if needed, to be Drugs Advisory Committee. determined. Advisory Committee for Pharmaceutical March 14. Science and Clinical Pharmacology. Psychopharmacologic Drugs Advisory Date(s), if needed, to...
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78 FR 32403 - Arthritis Advisory Committee; Notice of Meeting
2013-05-30
...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee..., the committee will discuss the Assessment of SpondyloArthritis international Society classification...
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77 FR 14529 - Arthritis Advisory Committee; Notice of Meeting
2012-03-12
...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee... the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had...
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75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting
2010-04-27
... of the treatment of hypoactive sexual desire disorder in premenopausal women. FDA intends to make... public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public... least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory...
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76 FR 29767 - Arthritis Advisory Committee; Notice of Meeting
2011-05-23
...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee... indication: ``ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to...
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76 FR 16427 - Risk Communication Advisory Committee; Notice of Meeting
2011-03-23
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss developments in FDA's ongoing communications programs. The discussion will focus on the use of...
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75 FR 20608 - Risk Communication Advisory Committee; Notice of Meeting
2010-04-20
...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... relevant to improving risk communication at FDA, and discuss applications or gaps for strategic planning of...
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77 FR 50702 - Cardiovascular and Renal Drugs Advisory Committee; Cancellation
2012-08-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Cardiovascular and Renal Drugs Advisory Committee scheduled for...
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75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting
2010-01-28
...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory... Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl...
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75 FR 71450 - Oncologic Drugs Advisory Committee; Amendment of Notice
2010-11-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a...
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Drugs@FDA: FDA Approved Drug Products
... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...
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77 FR 37911 - Oncologic Drugs Advisory Committee; Amendment of Notice
2012-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the...
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77 FR 50701 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting
2012-08-22
... always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down... (teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for the proposed indication of treatment of adult patients with short bowel syndrome. FDA intends to make background material available to the...
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78 FR 57166 - Antiviral Drugs Advisory Committee; Notice of Meeting
2013-09-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 31025 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-05-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 58399 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-09-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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78 FR 13348 - Oncologic Drugs Advisory Committee; Notice of Meeting
2013-02-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 32125 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-05-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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75 FR 9419 - Oncologic Drugs Advisory Committee; Notice of Meeting
2010-03-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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78 FR 48690 - Oncologic Drugs Advisory Committee; Notice of Meeting
2013-08-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 5813 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-02-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 82309 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-12-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 11489 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-03-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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75 FR 16151 - Antiviral Drugs Advisory Committee; Notice of Meeting
2010-03-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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77 FR 25184 - Oncologic Drugs Advisory Committee; Notice of Meeting
2012-04-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 44595 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 62418 - Antiviral Drugs Advisory Committee; Notice of Meeting
2011-10-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 82310 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-12-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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76 FR 65736 - Oncologic Drugs Advisory Committee; Notice of Meeting
2011-10-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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75 FR 75680 - Oncologic Drugs Advisory Committee; Notice of Meeting
2010-12-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...
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75 FR 52605 - Veterinary Medicine Advisory Committee; Notice of Meeting
2010-08-26
...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory..., Rockville, MD 20852, 301-468-1100. Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3...
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78 FR 734 - Medical Imaging Drugs Advisory Committee; Notice of Meeting
2013-01-04
...] Medical Imaging Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Medical Imaging Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 9420 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-03-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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76 FR 29766 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2011-05-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 4566 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-01-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 69635 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-11-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 5334 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-02-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 82031 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-12-29
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 74486 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-12-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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77 FR 69636 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2012-11-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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75 FR 5333 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2010-02-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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78 FR 46976 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
2013-08-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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78 FR 76307 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-12-17
...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. FDA intends...
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78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting
2013-02-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...
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77 FR 12062 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2012-02-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee...
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78 FR 64956 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
2013-10-30
... treatment of metabolic disorders associated with lipodystrophy, including diabetes mellitus and/or... than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a... 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee...
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78 FR 104 - Advisory Committees; Tentative Schedule of Meetings for 2013
2013-01-02
... Advisory Committee. Advisory Committee for Pharmaceutical Date(s), if needed, to be Science and Clinical... 11-12, April 29-30, August 15-16, December 16-17. Science Board to FDA February 27, June 24, November... Committee. Date(s), if needed, to be determined. NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR) Science...
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2011-06-29
...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General..., 2011, the committee will discuss current strategies for FDA's Office of Pharmaceutical Science...
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77 FR 43093 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2012-07-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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78 FR 38717 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-06-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 35496 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-06-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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77 FR 43600 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2012-07-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 1395 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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78 FR 36787 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2013-06-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 52762 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-08-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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75 FR 30839 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2010-06-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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76 FR 82310 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2011-12-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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76 FR 39404 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
2011-07-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...
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78 FR 63224 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
2013-10-23
... treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare congenital... Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate...Committees/Calendar/default.htm . Scroll down to the appropriate advisory committee meeting link. Procedure...
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77 FR 42319 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2012-07-18
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture. FDA...
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77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2012-01-25
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The...
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2010-03-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2011-01-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2013-07-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2012-07-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2012-07-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2012-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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2010-02-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...
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75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2010-05-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...
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75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2010-01-19
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2010 - 2011 influenza season. FDA intends to make background material available to...
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78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
2013-01-25
...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2013- 2014 influenza season. FDA intends to make background material available to...
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75 FR 66381 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2010-10-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...
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76 FR 49774 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2011-08-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...
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76 FR 64951 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2011-10-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...
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78 FR 15726 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
2013-03-12
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of...
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2010-09-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug Safety... and Central Nervous System Drugs Advisory Committee and the Drug Safety and Risk Management Advisory...
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2010-03-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...
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76 FR 44595 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2011-07-26
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee...
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2011-09-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General...
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75 FR 12768 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2010-03-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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78 FR 20328 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2013-04-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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78 FR 63478 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2013-10-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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75 FR 36428 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2010-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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77 FR 20037 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2012-04-03
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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76 FR 3912 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2011-01-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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75 FR 17417 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2010-04-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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78 FR 63481 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
2013-10-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...
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2011-03-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...
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2013-05-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...
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76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
2011-08-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...
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2012-03-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...
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2011-11-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...
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2011-09-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...
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2011-02-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory...
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2010-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice...
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2010-08-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...
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2011-10-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...
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2012-02-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public...
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76 FR 59404 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting
2011-09-26
..., efficacy, and durability of response with repeat treatment cycles of XIFAXAN (rifaximin), by Salix Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea. FDA intends to make background material...Committees/Calendar/default.htm . Scroll down to the appropriate advisory committee link. Procedure...
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75 FR 2880 - Homeland Security Advisory Council
2010-01-19
... the Secretary's primary advisory body with the goal of providing strategic, timely and actionable... portions of the meeting will include updates on operational challenges, intelligence briefings, and pre... procedures. HSAC members will receive classified and sensitive intelligence briefings during the closed...
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Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.
Deyo, Richard A
2004-01-01
Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.
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2011-10-14
...] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and... Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management... Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1...
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2012-08-06
...) (1) Opening Remarks. (2) Briefing on Ethics and the Federal Advisory Committee Act. (3) Discussion on..., FICEMS and Federal EMS Programming. (5) Update on Programs from the NHTSA Office of EMS and FICEMS...
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78 FR 70954 - Risk Communications Advisory Committee; Notice of Meeting
2013-11-27
... awareness and understanding of the key risk messages, as well as whether the communications are having the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Risk Communications Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...
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U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...
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In Brief: NASA Advisory Council structure
Showstack, Randy
2009-11-01
NASA Administrator Charles Bolden has added four new committees to the NASA Advisory Council in the areas of commercial space, education and public outreach, information technology infrastructure, and technology and innovation, the agency announced on 2 November. Other committees are in the areas of aeronautics; audit, finance, and analysis; exploration; science; and space operations. The council, which provides advice and makes recommendations to the administrator about agency programs, policies, plans, financial controls, and other matters, holds its next meeting on 18-19 February 2010. For more information, visit http://www.nasa.gov/offices/nac/home/index.html.
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Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton
2012-01-01
Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.
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75 FR 54299 - Agenda and Notice of Public Meeting of the Massachusetts State Advisory Committee
2010-09-07
.... Commission on Civil Rights and the Federal Advisory Committee Act, that briefing and planning meetings of the... Advisory Committee to continue its work on English Language Learners. The purpose of the planning meeting... COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meeting of the Massachusetts State Advisory...
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Students As Stakeholders: Library Advisory Boards and Privileging Our Users
Directory of Open Access Journals (Sweden)
Erin Dorney
2013-02-01
Full Text Available In Brief: This article investigates the idea of library student advisory boards as mechanisms for building more student-centered libraries at colleges and universities. Benefits of these types of organizations, measures of success, and the importance of acting on evidence-based user feedback are discussed. Introduction A Google search for “library student advisory board” returns hundreds of results [...
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FDA regulation of tobacco: blessing or curse for FDA professionals?
O'Reilly, James T
2009-01-01
Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.
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FDA Acronyms and Abbreviations
U.S. Department of Health & Human Services — The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities
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75 FR 39910 - Dixie Resource Advisory Committee
2010-07-13
... introductions, review the Federal Advisory Committee Act requirements, brief participants on Payments to States legislative history, discuss the guidelines for Title II and Title III funding and proposals, discuss...., Eastern Standard Time, Monday through Friday. SUPPLEMENTARY INFORMATION: The meetings are open to the...
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75 FR 26918 - Fishlake Resource Advisory Committee
2010-05-13
... requirements, brief participants on Payments to States legislative history, discuss the guidelines for Title II... following business will be conducted: (1) Welcome and Committee introductions; (2) Federal Advisory Committee Act overview and powerpoint; (3) review of Payments to States legislative history and discussion...
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2013-10-29
... medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco... Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women... membership, the primary contact is: Caryn Cohen, Office of Science, Center for Tobacco Products, Food and...
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International Nuclear Information System (INIS)
1995-01-01
This large document provides a catalog of the location of large numbers of reports pertaining to the charge of the Presidential Advisory Committee on Human Radiation Research and is arranged as a series of appendices. Titles of the appendices are Appendix A- Records at the Washington National Records Center Reviewed in Whole or Part by DoD Personnel or Advisory Committee Staff; Appendix B- Brief Descriptions of Records Accessions in the Advisory Committee on Human Radiation Experiments (ACHRE) Research Document Collection; Appendix C- Bibliography of Secondary Sources Used by ACHRE; Appendix D- Brief Descriptions of Human Radiation Experiments Identified by ACHRE, and Indexes; Appendix E- Documents Cited in the ACHRE Final Report and other Separately Described Materials from the ACHRE Document Collection; Appendix F- Schedule of Advisory Committee Meetings and Meeting Documentation; and Appendix G- Technology Note
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Energy Technology Data Exchange (ETDEWEB)
NONE
1995-01-01
This large document provides a catalog of the location of large numbers of reports pertaining to the charge of the Presidential Advisory Committee on Human Radiation Research and is arranged as a series of appendices. Titles of the appendices are Appendix A- Records at the Washington National Records Center Reviewed in Whole or Part by DoD Personnel or Advisory Committee Staff; Appendix B- Brief Descriptions of Records Accessions in the Advisory Committee on Human Radiation Experiments (ACHRE) Research Document Collection; Appendix C- Bibliography of Secondary Sources Used by ACHRE; Appendix D- Brief Descriptions of Human Radiation Experiments Identified by ACHRE, and Indexes; Appendix E- Documents Cited in the ACHRE Final Report and other Separately Described Materials from the ACHRE Document Collection; Appendix F- Schedule of Advisory Committee Meetings and Meeting Documentation; and Appendix G- Technology Note.
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2013-04-25
... on FDA's regulatory issues. Date and Time: The meeting will be held on July 24 and 25, 2013, from 8 a... confirmed by patient history, physical examination, and radiographic studies. FDA intends to make background... notify the contact person and submit a brief statement of the general nature of the evidence or arguments...
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2013-03-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2012-04-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-03-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-10-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2010-08-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2013-05-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-07-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2010-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...
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FDA Warns About Stem Cell Therapies
... Home For Consumers Consumer Updates FDA Warns About Stem Cell Therapies Share Tweet Linkedin Pin it More sharing ... see the boxed section below for more advice. Stem Cell Uses and FDA Regulation The FDA has the ...
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2013-03-05
... FDA's Product Tracing Web page at http://www.fda.gov/Food/FoodSafety/FSMA/ucm270851.htm . This... Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Request for Comments and... Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food...
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2010-10-05
...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the..., FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...
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Doblin, Rick
2002-01-01
The FDA and the Spanish Ministry of Health have concluded that the risk/benefit ratio is favorable under certain circumstances for clinical studies investigating MDMA-assisted psychotherapy. Both agencies have approved pilot studies in chronic posttraumatic stress disorder (PTSD) patients who have failed to obtain relief from at least one course of conventional treatment. These studies, the only ones in the world into the therapeutic use of MDMA, are being funded by a nonprofit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org). A rationale is offered explaining why MAPS chose to focus its limited resources on MDMA, and also on PTSD patients. A Clinical Plan is elaborated for the conduct of the "adequate and well-controlled" trials necessary to evaluate the safety and efficacy of MDMA-assisted psychotherapy for PTSD, with the studies estimated to cost about 5 million dollars and to take about five years. The Clinical Plan has been developed, in part, through analysis of the studies conducted by Pfizer in its successful effort to have Zoloft approved by the FDA for use with PTSD patients, and through review of transcripts of the FDA's Psychopharmacologic Drugs Advisory Committee meeting that recommended approval of Zoloft for PTSD.
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2011-07-19
...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the... INFORMATION: In the Federal Register of July 7, 2011, FDA announced that a meeting of the General and Plastic...
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The Food and Drug Administration and Drug Legalization: A Brief Model of Regulation
Kalam, Murad
2002-01-01
This paper offers a brief model of FDA regulation of currently illegal narcotics in the United States. Given that nearly three out of four Americans believe that the drug war has failed, recent calls from prominent liberal and conservative thinkers to legalize drugs, and state “compassionate use†ballot initiatives, future drug legalization is at least conceivable in the United States. Yet, how would the FDA regulate NLD’s under its current st...
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FDA Peanut-Containing Product Recall
U.S. Department of Health & Human Services — The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...
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77 FR 69551 - Advisory Committee on Women Veterans; Notice of Meeting
2012-11-19
... Administration; and briefings on health care for women Veterans, mental health, women Veterans' legislative... regarding the needs of women Veterans with respect to health care, rehabilitation, compensation, outreach... DEPARTMENT OF VETERANS AFFAIRS Advisory Committee on Women Veterans; Notice of Meeting The...
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77 FR 7244 - Advisory Committee on Women Veterans, Notice of Meeting
2012-02-10
..., and the Women Veterans Health Strategic Health Care Group; and briefings on mental health, women... regarding the needs of women Veterans with respect to health care, rehabilitation, compensation, outreach... DEPARTMENT OF VETERANS AFFAIRS Advisory Committee on Women Veterans, Notice of Meeting The...
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Lessons learned from the Three Mile Island Unit 2 Advisory Panel
International Nuclear Information System (INIS)
Lach, D.; Bolton, P.; Durbin, N.; Harty, R.
1994-08-01
In response to public concern about the cleanup of the Three Mile Island, Unit 2 (TMI-2) facility after an accident on March 28, 1979 involving a loss of reactor coolant and subsequent damage to the reactor fuel, twelve citizens were asked to serve on an independent Advisory Panel to consult with the Nuclear Regulatory Commission (NRC) on the decontamination and cleanup of the facility. The panel met 78 times over a period of thirteen years, holding public meetings in the vicinity of TMI-2 and meeting regularly with NRC Commissioners in Washington, DC. This report describes the results of a project designed to identify and describe the lessons learned from the Advisory Panel and place those lessons in the context of what we generally know about citizen advisory groups. A summary of the empirical literature on citizen advisory panels is followed by a brief history of the TMI-2 Advisory Panel. The body of the report contains the analysis of the lessons learned, preliminary conclusions about the effectiveness of the Panel, and implications for the NRC in the use of advisory panels. Data for the report include meeting transcripts and interviews with past and present Panel participants
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75 FR 24927 - Federal Advisory Committee; Military Leadership Diversity Commission (MLDC)
2010-05-06
... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; Military Leadership... amended), and 41 CFR 102-3.150, the Department of Defense announces that the Military Leadership Diversity... diversity management Mr. Mario L. Barnes briefs the MLDC on legal issues related to diversity management...
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78 FR 72718 - NASA Advisory Council; Audit, Finance and Analysis Committee; Meeting
2013-12-03
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (13-139)] NASA Advisory Council; Audit... amended, the National Aeronautics and Space Administration announces a meeting of the Audit, Finance and... includes briefings on the following topics: Finance Update Budget Update NASA Strategic Planning and...
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2011-07-14
... consider surgical mesh used to treat stress urinary incontinence. FDA intends to make background material... contact person and submit a brief statement of the general nature of the evidence or arguments they wish...
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21 CFR 60.34 - FDA action on petitions.
2010-04-01
... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... this section or investigate and determine under § 60.36 whether the applicant acted with due diligence during the regulatory review period. FDA will publish its due diligence determination in the Federal...
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Energy Technology Data Exchange (ETDEWEB)
Kraus, Terrence D.; Hunt, Brian D.
2014-02-01
This report reviews the method recommended by the U.S. Food and Drug Administration for calculating Derived Intervention Levels (DILs) and identifies potential improvements to the DIL calculation method to support more accurate ingestion pathway analyses and protective action decisions. Further, this report proposes an alternate method for use by the Federal Emergency Radiological Assessment Center (FRMAC) to calculate FRMAC Intervention Levels (FILs). The default approach of the FRMAC during an emergency response is to use the FDA recommended methods. However, FRMAC recommends implementing the FIL method because we believe it to be more technically accurate. FRMAC will only implement the FIL method when approved by the FDA representative on the Federal Advisory Team for Environment, Food, and Health.
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78 FR 61400 - Advisory Committee for Education and Human Resources; Notice of Meeting
2013-10-03
... NATIONAL SCIENCE FOUNDATION Advisory Committee for Education and Human Resources; Notice of...) education and human resources programming. Agenda November 6, 2013 Remarks by the Committee Chair and NSF Assistant Director for Education and Human Resources (EHR) Brief updates on EHR and Committee of Visitor...
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International Nuclear Information System (INIS)
Eccleston, R.C.; Barnett, M.H.
1977-04-01
The report provides a brief overview of the FDA's major regulatory and voluntary efforts in the area of radiation control, and examines the impact of the Agency's programs to eliminate unproductive radiation exposure to the American consumer. It concludes with a summary of present and future concerns about newly emerging radiation-emitting products and uses, and the potential public health problems which they may engender
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76 FR 1641 - Meeting of the Office of Justice Programs' Science Advisory Board
2011-01-11
... and By-Laws, a review of ethics rules applicable to the Board's activities, and briefings from OJP... DEPARTMENT OF JUSTICE Office of Justice Programs [OJP (OJP) Docket No. 1543] Meeting of the Office of Justice Programs' Science Advisory Board AGENCY: Office of Justice Programs (OJP), Justice. ACTION...
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Folbert, J.P.; Dagevos, J.C.
2001-01-01
De oprichting van een Europese Voedselautoriteit die in 2002 operationeel moet zijn. Velen zien hierin een evenbeeld van de Amerikaanse FDA (Food and Drug Administration). Deze instantie werkt echter niet zo ideaal als vaak wordt voorgesteld. Het belangrijkste verschil tussen beide instanties is de
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U.S. Department of Health & Human Services — This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number...
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FDA and the Chemical Brain Drainers
DEFF Research Database (Denmark)
Grandjean, Philippe
2017-01-01
Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907......Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907...
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Towards a Computational Analysis of Status and Leadership Styles on FDA Panels
Broniatowski, David A.; Magee, Christopher L.
Decisions by committees of technical experts are increasingly impacting society. These decision-makers are typically embedded within a web of social relations. Taken as a whole, these relations define an implicit social structure which can influence the decision outcome. Aspects of this structure are founded on interpersonal affinity between parties to the negotiation, on assigned roles, and on the recognition of status characteristics, such as relevant domain expertise. This paper build upon a methodology aimed at extracting an explicit representation of such social structures using meeting transcripts as a data source. Whereas earlier results demonstrated that the method presented here can identify groups of decision-makers with a contextual affinity (i.e., membership in a given medical specialty or voting clique), we now can extract meaningful status hierarchies, and can identify differing facilitation styles among committee chairs. Use of this method is demonstrated on the transcripts of U.S. Food and Drug Administration (FDA) advisory panel meeting transcripts; nevertheless, the approach presented here is extensible to other domains and requires only a meeting transcript as input.
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FDA Recognized Consensus Standards
U.S. Department of Health & Human Services — This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information...
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21 CFR 60.10 - FDA assistance on eligibility.
2010-04-01
... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in... in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852...
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76 FR 9742 - Agenda and Notice of Public Meeting of the Vermont Advisory Committee
2011-02-22
... Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that briefing and planning... of the planning meeting is to plan future activities. Members of the public are entitled to submit... below. Persons who are deaf or hearing-impaired who will attend the meetings and require the services of...
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76 FR 16378 - Agenda and Notice of Public Meeting of the Vermont Advisory Committee
2011-03-23
... Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that briefing and planning... of the planning meeting is to plan future activities. Members of the public are entitled to submit... below. Persons who are deaf or hearing-impaired who will attend the meetings and require the services of...
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Changes In Growth Culture FDA Activity Under Changing Growth Conditions
DEFF Research Database (Denmark)
Jørgensen, Per Elberg; Eriksen, Thomas Juul; Jensen, Bjørn K.
1992-01-01
The FDA hydrolysis capacities and bacterial biomass concentrations (estimated by determination of ATP content) of growth cultures prepared from activated sludge and wastewater, were measured to find out whether the FDA activity would reflect bacterial biomass under different physiological states...... of the bacteria. The FDA activity/ATP ratio was calculated for different concentrations of autoclaved sludge. A faster decay rate of ATP relative to FDA hydrolysis activity was observed, thus causing changes in the ratio. Furthermore, comparison between values obtained from pure cultures and different soils...... revealed differences up to two orders of magnitude of the ratio. Based on these results it was concluded that the FDA activity should not be applied for measurements of viable biomass in environments in which different physiological conditions occur....
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Subarray-based FDA radar to counteract deceptive ECM signals
Abdalla, Ahmed; Wang, Wen-Qin; Yuan, Zhao; Mohamed, Suhad; Bin, Tang
2016-12-01
In recent years, the frequency diverse array (FDA) radar concept has attracted extensive attention, as it may benefit from a small frequency increment, compared to the carrier frequency across the array elements and thereby achieve an array factor that is a function of the angle, the time, and the range which is superior to the conventional phase array radar (PAR). However, limited effort on the subject of FDA in electronic countermeasure scenarios, especially in the presence of mainbeam deceptive jamming, has been published. Basic FDA is not desirable for anti-jamming applications, due to the range-angle coupling response of targets. In this paper, a novel method based on subarrayed FDA signal processing is proposed to counteract deceptive ECM signals. We divide the FDA array into multiple subarrays, each of which employs a distinct frequency increment. As a result, in the subarray-based FDA, the desired target can be distinguished at subarray level in joint range-angle-Doppler domain by utilizing the fact that the jammer generates false targets with the same ranges to each subarray without reparations. The performance assessment shows that the proposed solution is effective for deceptive ECM targets suppression. The effectiveness is verified by simulation results.
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Lithuanian Nuclear Safety Advisory Committee - 1993-2003
International Nuclear Information System (INIS)
Medeliene, D.
2003-01-01
Brief overview of the Lithuanian Nuclear Safety Advisory Committee (LNSAC) activities is presented. LNSAC was established in May 1993, main task is to advise the Lithuanian government on industrial and regulatory matters of nuclear safety. One of the most of important tasks was to exert pressure on the Government so that it allocates sufficient funds from the national budget for setting up a national regulatory body. Statements of the members of LNSAC are presented. In the CD minutes of the meetings of the LNSAC in 1993-2003 and official documents regulating Committee activities are included
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Regulating nanomedicine - can the FDA handle it?
Bawa, Raj
2011-05-01
There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle
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76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry
2011-01-07
...] FDA Transparency Initiative: Improving Transparency to Regulated Industry AGENCY: Food and Drug... the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The...
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Driver, Vickie R; Gould, Lisa J; Dotson, Peggy; Gibbons, Gary W; Li, William W; Ennis, William J; Kirsner, Robert S; Eaglstein, William H; Bolton, Laura L; Carter, Marissa J
2017-05-01
Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the U.S. Food and Drug Administration (FDA) using multiple endpoints but the requirement of complete healing as a primary endpoint for wound products impedes FDA clearance of interventions that can provide other clinical or patient-centered benefits for persons with wounds. A multidisciplinary group of wound experts undertook an initiative, in collaboration with the FDA, to identify and content validate supporting FDA criteria for qualifying wound endpoints relevant to clinical practice (CP) and patient-centered outcomes (PCO) as primary outcomes in clinical trials. As part of the initiative, a research study was conducted involving 628 multidisciplinary expert wound clinicians and researchers from 4 different groups: the interdisciplinary core advisory team; attendees of the Spring 2015 Symposium on Advanced Wound Care (SAWC); clinicians employed by a national network of specialty clinics focused on comprehensive wound care; and Association for the Advancement of Wound Care (AAWC) and Wound Healing Society (WHS) members who had not previously completed the survey. The online survey assessed 28 literature-based wound care endpoints for their relevance and importance to clinical practice and clinical research. Fifteen of the endpoints were evaluated for their relevance to improving quality of life. Twenty-two endpoints had content validity indexes (CVI) ≥ 0.75, and 15 were selected as meriting potential inclusion as additional endpoints for FDA approval of future wound care interventions. This study represents an important first step in identifying and validating new measurable wound care endpoints for clinical research and practice and for regulatory
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21 CFR 312.86 - Focused FDA regulatory research.
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency...
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Gottlieb, the FDA and dumbing down medicine
Robbins RA
2017-01-01
No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some wh...
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76 FR 9742 - Agenda and Notice of Public Meeting of the New Jersey State Advisory Committee
2011-02-22
.... Commission on Civil Rights and the Federal Advisory Committee Act (FACA), that briefing and planning meetings... of the planning meeting is to plan future activities. The purpose of the press conference is to... contact the ERO. See contact information below. Persons who are deaf or hearing-impaired who will attend...
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Gottlieb, the FDA and dumbing down medicine
Directory of Open Access Journals (Sweden)
Robbins RA
2017-04-01
Full Text Available No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1. Others praised Gottlieb as the right man to lead the FDA. As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2. Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight …
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National Commission on Libraries and Information Science, Washington, DC.
This report begins with an executive summary and an introduction; the introduction provides a brief statement about the innovative process which led to the proposal to establish a National Advisory Board on Rural Information Needs (NABRIN) in the U.S. Department of Agriculture (USDA). A background statement gives an overview of the many problems…
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42 CFR 405.203 - FDA categorization of investigational devices.
2010-10-01
... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational.../investigational (Category A) or non-experimental/investigational (Category B). (c) CMS uses the categorization of...
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FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files
U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...
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27 CFR 24.246 - Materials authorized for the treatment of wine and juice.
2010-04-01
... derived from Aspergillus niger, Aspergillus oryzae, Bacillus subtilis, or barley malt per FDA advisory... shall be derived from Aspergillus niger or Aspergillus oryzae per FDA advisory opinion dated 8/18/83 or... clarify and to stabilize wine The enzyme activity used shall be derived from Aspergillus niger or bovine...
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Healthy public relations: the FDA's 1930s legislative campaign.
Kay, G
2001-01-01
In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more.
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International Nuclear Information System (INIS)
Chadwick, K.H.
1981-01-01
In 1977 the IAEA established a programme on High-Dose Standardization and Intercomparison with the aim of developing a world-wide service for dosimetry assurance in Industrial and Research Radiation Processing Facilities. The complete proceedings of the first Advisory Group meeting held within this programme have recently been published in the IAEA Technical Reports Series (No. 205) under the title ''High-Dose Measurement in Industrial Radiation Processing''. This report of the second Advisory Group meeting provides a brief review of the state of the programme at the present time. (The full proceedings of the meeting will not be published)
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FDA Approves First Therapeutic Cancer Vaccine
Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.
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75 FR 43156 - Federal Advisory Committee; Missile Defense Advisory Committee
2010-07-23
... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; Missile Defense Advisory Committee AGENCY: Missile Defense Agency (MDA), DoD. ACTION: Notice of closed meeting. SUMMARY: Under the... Defense announces that the Missile Defense Advisory Committee will meet on August 4 and 5, 2010, in...
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Mining FDA drug labels for medical conditions.
Li, Qi; Deleger, Louise; Lingren, Todd; Zhai, Haijun; Kaiser, Megan; Stoutenborough, Laura; Jegga, Anil G; Cohen, Kevin Bretonnel; Solti, Imre
2013-04-24
Cincinnati Children's Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration's (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system.
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Environmental assessments and findings of no significant impact--FDA. Notice.
1998-05-18
The Food and Drug Administration (FDA) is announcing that it has reviewed environmental assessments (EA's) and issued findings of no significant impact (FONSI's) relating to the 167 new drug applications (NDA's) and supplemental applications listed in this document. FDA is publishing this notice because Federal regulations require public notice of the availability of environmental documents.
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21 CFR 516.34 - FDA recognition of exclusive marketing rights.
2010-04-01
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive...
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Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations
Xu, Liren; Zhang, Chen; Rungta, Meha; Qiu, Wulin; Liu, Junqiang; Koros, William J.
2014-01-01
This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family
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Gas separation performance of 6FDA-based polyimides with different chemical structures
Qiu, Wulin
2013-10-01
This work reports the gas separation performance of several 6FDA-based polyimides with different chemical structures, to correlate chemical structure with gas transport properties with a special focus on CO2 and CH 4 transport and plasticization stability of the polyimides membranes relevant to natural gas purification. The consideration of the other gases (He, O2 and N2) provided additional insights regarding effects of backbone structure on detailed penetrant properties. The polyimides studied include 6FDA-DAM, 6FDA-mPDA, 6FDA-DABA, 6FDA-DAM:DABA (3:2), 6FDA-DAM:mPDA (3:2) and 6FDA-mPDA:DABA (3:2). Both pure and binary gas permeation were investigated. The packing density, which is tunable by adjusting monomer type and composition of the various samples, correlated with transport permeability and selectivity. The separation performance of the polyimides for various gas pairs were also plotted for comparison to the upper bound curves, and it was found that this family of materials shows attractive performance. The CO 2 plasticization responses for the un-cross-linked polyimides showed good plasticization resistance to CO2/CH4 mixed gas with 10% CO2; however, only the cross-linked polyimides showed good plasticization resistance under aggressive gas feed conditions (CO 2/CH4 mixed gas with 50% CO2 or pure CO 2). For future work, asymmetric hollow fibers and carbon molecular sieve membranes based on the most attractive members of the family will be considered. © 2013 Elsevier Ltd. All rights reserved.
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Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations
Xu, Liren
2014-06-01
This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family with attractive dense film properties for several potential applications. The work reported here for the 6FDA-DAM polyimide provides insight for the challenging fabrication of defect-free asymmetric hollow fiber membranes for this class of 6FDA-polyimides, which behave rather different from lower free volume polymers. Specifically, the 6FDA based materials show relatively slow phase separation rate in water quench baths, which presents a challenge for fiber spinning. For convenience, we refer to the behavior as more "non-solvent resistant" in comparison to other lower free volume polymers, since the binodal phase boundary is displaced further from the conventional position near the pure polymer-solvent axis on a ternary phase diagram in conventional polymers like Matrimid® and Ultem®. The addition of lithium nitrate to promote phase separation has a useful impact on 6FDA-DAM asymmetric hollow fiber formation. 6FDA-DAM phase diagrams using ethanol and water as non-solvent are reported, and it was found that water is less desirable as a non-solvent dope additive for defect-free fiber spinning. Phase diagrams are also reported for 6FDA-DAM dope formulation with and without the addition of lithium nitrate, and defect-free asymmetric hollow fiber membranes are reported for both cases. The effect of polymer molecular weight on defect-free fiber spinning was also investigated. Gas transport properties and morphology of hollow fibers were characterized. With several thorough case studies, this work provides a systematic guideline for defect-free fiber formation from 6FDA-polymers. © 2014 Elsevier B.V.
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2012-11-21
... Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National Cancer Advisory Board... Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National...: National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and...
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Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.
KuKanich, Butch; Warner, Matt; Hahn, Kevin
2017-02-01
OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.
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Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
Yu, Lawrence X; Baker, Jeffrey; Berlam, Susan C; Boam, Ashley; Brandreth, E J; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M V; Mullin, Theresa; Raju, G K; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar
2015-07-01
On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.
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FDA-approved small-molecule kinase inhibitors
DEFF Research Database (Denmark)
Wu, Peng; Nielsen, Thomas E.; Clausen, Mads Hartvig
2015-01-01
Kinases have emerged as one of the most intensivelypursued targets in current pharmacological research,especially for cancer, due to their critical roles in cellularsignaling. To date, the US FDA has approved 28 smallmoleculekinase inhibitors, half of which were approvedin the past 3 years. While...
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Barbecue Basics: Tips to Prevent Foodborne Illness
Full Text Available ... View FDA videos on YouTube View FDA photos on Flickr FDA Archive Combination Products Advisory Committees Regulatory Information Safety Emergency Preparedness International Programs News & Events Training & Continuing Education Inspections & Compliance Federal, State & Local Officials Consumers Health ...
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Animation of Antimicrobial Resistance
Full Text Available ... View FDA videos on YouTube View FDA photos on Flickr FDA Archive Combination Products Advisory Committees Regulatory Information Safety Emergency Preparedness International Programs News & Events Training & Continuing Education Inspections & Compliance Federal, State & Local Officials Consumers Health ...
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Full Text Available ... View FDA videos on YouTube View FDA photos on Flickr FDA Archive Combination Products Advisory Committees Regulatory Information Safety Emergency Preparedness International Programs News & Events Training & Continuing Education Inspections & Compliance Federal, State & Local Officials Consumers Health ...
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Fortify Your Knowledge about Vitamins
Full Text Available ... View FDA videos on YouTube View FDA photos on Flickr FDA Archive Combination Products Advisory Committees Regulatory Information Safety Emergency Preparedness International Programs News & Events Training & Continuing Education Inspections & Compliance Federal, State & Local Officials Consumers Health ...
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Full Text Available ... View FDA videos on YouTube View FDA photos on Flickr FDA Archive Combination Products Advisory Committees Regulatory Information Safety Emergency Preparedness International Programs News & Events Training & Continuing Education Inspections & Compliance Federal, State & Local Officials Consumers Health ...
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Underhill, Kristen; Morrow, Kathleen M; Operario, Don; Mayer, Kenneth H
2014-02-01
The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while others perceived approval as irrelevant or less significant than other sources of information. Our results suggest that FDA approval sends a signal that directly shapes PrEP acceptability among some MSM, while indirect influences of approval may affect uptake by others. Efforts to educate MSM about PrEP can increase acceptability by incorporating information about FDA approval, and outreach strategies should consider how this information may factor into personal decisions about PrEP use.
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75 FR 36373 - Federal Advisory Committee; Advisory Council on Dependents' Education
2010-06-25
..., the Department of Defense announces that the Advisory Council on Dependents' Education will meet on... response to the stated agenda of the planned meeting of the Advisory Council on Dependents' Education. All... membership for their consideration. For the next meeting of the Advisory Council on Dependents' Education, Dr...
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Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.
McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D
2017-01-01
Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.
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75 FR 22757 - Federal Advisory Committee; Army Education Advisory Committee; Charter Renewal
2010-04-30
..., school curriculums, educational philosophy and objectives, program effectiveness, facilities, staff and... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; Army Education Advisory... Defense gives notice that it is renewing the charter for the Army Education Advisory Committee (hereafter...
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Evaluating eating behavior treatments by FDA standards
Directory of Open Access Journals (Sweden)
A. Janet eTomiyama
2014-01-01
Full Text Available Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require the patients’ time and investment, and may have risks. The Food and Drug Administration (FDA has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1 Is the treatment safe? (2 How dangerous is the condition the intervention is treating? (3 Is the treatment effective? (4 Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine.
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Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?
Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E
2015-10-01
The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.
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75 FR 51985 - Federal Advisory Committee; Advisory Council on Dependents' Education (ACDE)
2010-08-24
... Advisory Council on Dependents' Education (ACDE) scheduled for September 8, 2010, is cancelled. The meeting... submit written statements to the Advisory Council on Dependents' Education about its mission and... planned meeting of the Advisory Council on Dependents' Education. All written statements shall be...
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2011-05-24
... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...
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FDA actions against health economic promotions, 2002-2011.
Neumann, Peter J; Bliss, Sarah K
2012-01-01
To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading. We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act. Of 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114. The FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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2011-05-23
... Management, for the purpose of identifying leading business practices that have the potential to improve...'s Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY: Office...: The President's Management Advisory Board, a Federal Advisory Committee established in accordance with...
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Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S
2011-01-01
Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Few physician-directed print pharmaceutical advertisements
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Directory of Open Access Journals (Sweden)
Deborah Korenstein
Full Text Available Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA; adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14. Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1% adhered to all FDA guidelines, 41 (49.4% were non-adherent with at least one form of FDA-described bias, and 27 (32.5% were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.Few physician-directed print pharmaceutical
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FDA regulations for commercial food irradiation
International Nuclear Information System (INIS)
Takeguchi, C.A.
1985-01-01
The Food and Drug Administration published an Advance Notice of Proposed Rulemaking (ANPR) on food irradiation on March 27, 1981 (FDA, 1981). The next step in the rulemaking process is a proposed rule that will deal with low-dose irradiation of certain foods and high-dose irradiation of spices. The status of the proposed regulation is discussed
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75 FR 9184 - Federal Advisory Committee; Advisory Council on Dependents' Education; Open Meeting
2010-03-01
... 102-3.150, the Department of Defense announces that the Advisory Council on Dependents' Education will... Advisory Council on Dependents' Education about its mission and functions. Written statements may be... Advisory Council on Dependents' Education, Mr. Charles Toth, telephone (703) 588-3105, 4040 North Fairfax...
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2011-08-19
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-074)] NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space... meeting of the NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel...
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FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology.
Grant, Evita V
Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.
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Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?
Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.
2015-01-01
Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691
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Small-molecule kinase inhibitors: an analysis of FDA-approved drugs
DEFF Research Database (Denmark)
Wu, Peng; Nielsen, Thomas Eiland; Clausen, Mads Hartvig
2016-01-01
Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther......Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function...
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2011-08-23
... DEPARTMENT OF DEFENSE Notice of Advisory Committee Closed Meeting; U.S. Strategic Command Strategic Advisory Group AGENCY: Department of Defense. ACTION: Notice of Advisory Committee closed meeting.... Strategic Command Strategic Advisory Group. DATES: November 1, 2011, from 8 a.m. to 5 p.m. and November 2...
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FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.
Wilson, Carolyn A; Simonyan, Vahan
2014-01-01
Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and
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TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities
International Nuclear Information System (INIS)
2016-01-01
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities
Energy Technology Data Exchange (ETDEWEB)
NONE
2016-06-15
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen
2014-01-01
The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications. © 2013 Pharmacotherapy Publications, Inc.
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FDA publishes checklist of Y2K high-risk devices.
1999-09-01
Key points. The federal Food and Drug Administration (FDA) has developed a list of types of medical devices that have the potential for the most serious consequences for patients should they fail because of Y2K-related problems. This list of computer-controlled potentially high-risk devices can provide a guide to health care facilities regarding the types of devices that should receive priority in their assessment and remediation of medical devices. The list may change as the FDA receives comments on the types of devices included in the list.
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High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations
Zhang, Chen; Dai, Ying; Johnson, Justin R.; Karvan, Oguz; Koros, William J.
2012-01-01
We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.
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High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations
Zhang, Chen
2012-02-01
We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.
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Dose Matters: FDA's Guidance on Children's X-rays
... Consumer Updates Dose Matters: FDA's Guidance on Children's X-rays Share Tweet Linkedin Pin it More sharing options ... exposure during medical procedures. The level of ionizing radiation from X-ray imaging is generally very low, but can ...
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2012-05-01
... DEPARTMENT OF DEFENSE Notice of Advisory Committee Closed Meeting; U.S. Strategic Command Strategic Advisory Group AGENCY: Department of Defense. ACTION: Notice of Advisory Committee closed meeting.... [[Page 25707
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Atmospheric Release Advisory Capability (ARAC): development and plans for implementation
International Nuclear Information System (INIS)
Dickerson, M.H.; Orphan, R.C.
1975-01-01
The Atmospheric Release Advisory Capability (ARAC) is an ERDA-sponsored service planned for nuclear facilities which require a means of real-time prediction of the extent of health hazards that may result from a release of radionuclides or other toxic materials. Since 1973 when the ARAC concept was initiated, a joint feasibility study has been conducted by Lawrence Livermore Laboratory and Savannah River Laboratory, and a prototype component of the system has been built and placed in operation. During the next three years plans are to implement the ARAC service for certain ERDA nuclear facilities. A brief description is presented of the ARAC concept, and progress to date is reported. (U.S.)
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Baker, Hannah M; Lee, Joseph G L; Ranney, Leah M; Goldstein, Adam O
2016-02-01
Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. All 50 states and the District of Columbia. Tobacco retailer inspections conducted by FDA (n = 33 543). State cigarette tax, youth smoking prevalence, poverty, and tobacco production. State proportion of FDA warning letters issued for single cigarette violations. There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Full Text Available ... Women For Women Homepage FDA Diabetes Information for Patients Page Last Updated: 02/16/2018 Note: If ... FDA Archive Combination Products Advisory Committees Regulatory Information Safety Emergency Preparedness International Programs News & Events Training & Continuing ...
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DEFF Research Database (Denmark)
Amarilyo, Gil; Furst, Daniel E; Woo, Jennifer M P
2016-01-01
BACKGROUND: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. OBJECTIVES: This study sought to determine if there are differences between the FDA assessments and journal...... reports on biologic agents developed for the treatment of rheumatoid arthritis. METHODS: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American...... College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report...
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Chambers, James D; May, Katherine E; Neumann, Peter J
2013-06-01
The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.
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Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.
Sarapa, Nenad
2007-09-01
The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.
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No sisyphean task: how the FDA can regulate electronic cigarettes.
Paradise, Jordan
2013-01-01
The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009
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2012-10-19
... ENVIRONMENTAL PROTECTION AGENCY [FRL--9743-2] Notification of a Public Teleconference of the Science Advisory Board; Perchlorate Advisory Panel AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office...
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Underhill, Kristen; Morrow, Kathleen M.; Operario, Don; Mayer, Kenneth H.
2014-01-01
The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while o...
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Black Hawk Coll., Moline, IL.
An advisory committee is generally comprised of persons outside the education profession who have specialized knowledge in a given area. The committee advises, makes recommendations, and gives service to the college and its students, instructors, and administrators. At Black Hawk College, there are four types of advisory committees: community,…
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Willis, Alexander R; Ippolito, Joseph A; Patterson, Francis R; Benevenia, Joseph; Beebe, Kathleen S
2016-01-01
Customizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Currently, obtaining customizable orthopaedic implants for orthopaedic oncology patients can be an arduous task involving submitting approval requests to the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). There is great potential for the delay of a patient's surgery and unnecessary paperwork if the submission pathways are misunderstood or a streamlined protocol is not in place. The objective of this study was to review the existing FDA custom implant approval pathways and to determine whether this process was improved with an institutional protocol. An institutional protocol for obtaining IRB and FDA approval for customizable orthopaedic implants was established with the IRB at our institution in 2013. This protocol was approved by the IRB, such that new patients only require submission of a modification to the existing protocol with individualized patient information. During the two-year period of 2013-2014, eight patients were retrospectively identified as having required customizable implants for various orthopaedic oncology surgeries. The dates of request for IRB approval, request for FDA approval, and total time to surgery were recorded, along with the specific pathway utilized for FDA approval. The average patient age was 12 years old (7-21 years old). The average time to IRB approval of a modification to the pre-approved protocol was 14 days (7-21 days). Average time to FDA approval after submission of the IRB approval to the manufacturer was 12.5 days (7-19 days). FDA approval was obtained for all implants as compassionate use requests in accordance with Section 561 of the Federal Food Drug and Cosmetic Act's expanded access provisions. Establishment of an institutional protocol with pre-approval by the IRB can expedite the otherwise time-consuming and complicated
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Directory of Open Access Journals (Sweden)
Bander Balkhi
2018-02-01
Conclusions: The 2010 FDA bisphosphonates safety communication appeared to have influenced Osteoporosis utilization in Medicaid recipients. The 2010 FDA bisphosphonates safety communication was associated with a significant reduction in the utilization of bisphosphonates in the Medicaid program.
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2010-06-14
... Closed Meetings of the Science Advisory Board's Scientific and Technological Achievement Awards Committee... Agency's (EPA), Science Advisory Board (SAB) Staff Office announces a meeting and teleconference of the....gov . The SAB Mailing address is: U.S. EPA Science Advisory Board (1400F), U.S. Environmental...
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Directory of Open Access Journals (Sweden)
Joy Kish
2014-10-01
Full Text Available The purpose of this study was to determine the characteristics and motivational factors of effective Extension advisory leaders. This Delphi study was conducted with a selected group of County Extension Directors and a group of Extension State Advisory Leaders. The study identified 10 characteristics that distinguish an effective Extension advisory leader. Some of these characteristics are explicit and easy to observe, while others are implicit and difficult to directly observe. Therefore, it is practical to use directly observable characteristics of effective advisory leaders when selecting volunteers. Once potential volunteers are spotted in the community, implicit characteristics of effective advisory leaders should be used to further screen them before they are selected. The study also identified the eight most important factors motivating individuals to volunteer as effective advisory leaders. Understanding these motivational factors is helpful for creating an environment for attracting and retaining effective volunteers. Understanding their motivation for volunteer work and creating an environment for them to meet the motivating factors for volunteering will lead to volunteer satisfaction and retention. The findings of this study can be used to build strong Extension advisory councils.
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78 FR 9010 - Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
2013-02-07
.... FDA-2012-N-1239] Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis AGENCY... condyle prostheses into class III, based on the recommendation of a Dental Products Panel (the Panel... Administration, Dental Products Advisory Panel Meeting Transcript, February 12, 1997; http://www.accessdata.fda...
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2011-07-27
... Closed Meetings of the Science Advisory Board's Scientific and Technological Achievement Awards Committee... Agency's (EPA), Science Advisory Board (SAB) Staff Office announces a meeting and teleconference of the[email protected] . The SAB Mailing address is: U.S. EPA Science Advisory Board (1400R), U.S. Environmental...
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2010-03-12
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9126-2] Science Advisory Board Staff Office; Notification of a Public Meeting of the Science Advisory Board (SAB) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff...
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Price, performance, and the FDA approval process: the example of home HIV testing.
Paltiel, A David; Pollack, Harold A
2010-01-01
The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process.
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Javitt, Gail H; Hudson, Kathy
2003-01-01
The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.
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5 CFR 724.403 - Advisory guidelines.
2010-01-01
... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Advisory guidelines. 724.403 Section 724.403 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...
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2011-11-07
... Drug Administration 21 CFR Part 866 Microbiology Devices; Classification of In Vitro Diagnostic Device... CFR Part 866 [Docket No. FDA-2011-N-0729] Microbiology Devices; Classification of In Vitro Diagnostic... of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the...
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2011-05-18
.... FDA-2011-N-0103] Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus... of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would... in the Federal Register. 1. Transcript of the FDA Microbiology Devices Panel meeting, March 7, 2002...
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2011-02-09
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9264-5] Science Advisory Board Staff Office; Notification of a Public Meeting of the Science Advisory Board Panel for the Review of EPA's Hydraulic Fracturing...-2098 or via e-mail at [email protected] . General information concerning the EPA Science Advisory...
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21 CFR 5.1110 - FDA public information offices.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...) Press Relations Staff. Press offices are located in White Oak Bldg. 1, 10903 New Hampshire Ave., Silver...
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Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.
Caliendo, Angela M; Hanson, Kimberly E
2016-04-01
Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.
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One and done: Reasons principal investigators conduct only one FDA-regulated drug trial
Directory of Open Access Journals (Sweden)
Amy Corneli, PhD, MPH
2017-06-01
Full Text Available Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as “one-and-done.” Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1 workload balance (balancing trial implementation with other work obligations and opportunities (63.8%; 2 time requirements (time to initiate and implement trial; investigator and staff time (63.4%; and 3 data and safety reporting (56.5%. Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly “one-and-done.” Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.
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2010-06-14
... a Public Meeting of the Science Advisory Board Exposure and Human Health Committee (EHHC) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Science Advisory Board (SAB) Staff... Science Advisory Board can be found on the SAB Web site at http://www.epa.gov/sab . SUPPLEMENTARY...
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2011-07-08
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9431-7] Science Advisory Board Staff Office; Notification of a Public Meeting of the Science Advisory Board Panel for the Review of Great Lakes Restoration... information concerning the EPA Science Advisory Board can be found at the EPA SAB Web site at http://www.epa...
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We really need to talk: adapting FDA processes to rapid change.
Lykken, Sara
2013-01-01
The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.
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THPdb: Database of FDA-approved peptide and protein therapeutics.
Directory of Open Access Journals (Sweden)
Salman Sadullah Usmani
Full Text Available THPdb (http://crdd.osdd.net/raghava/thpdb/ is a manually curated repository of Food and Drug Administration (FDA approved therapeutic peptides and proteins. The information in THPdb has been compiled from 985 research publications, 70 patents and other resources like DrugBank. The current version of the database holds a total of 852 entries, providing comprehensive information on 239 US-FDA approved therapeutic peptides and proteins and their 380 drug variants. The information on each peptide and protein includes their sequences, chemical properties, composition, disease area, mode of activity, physical appearance, category or pharmacological class, pharmacodynamics, route of administration, toxicity, target of activity, etc. In addition, we have annotated the structure of most of the protein and peptides. A number of user-friendly tools have been integrated to facilitate easy browsing and data analysis. To assist scientific community, a web interface and mobile App have also been developed.
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2013-02-25
...] Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee... be open to the public. Name of Committees: Medical Imaging Drugs Advisory Committee and the Oncologic... Special Medical Programs. [FR Doc. 2013-04141 Filed 2-22-13; 8:45 am] BILLING CODE 4160-01-P ...
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ITS Standards Advisory : Dynamic Message Signs (DMS)
2003-01-01
ITS Standards Advisories provide the transportation community with information and guidance on key activities related to ITS standards, with each Advisory focusing on a single ITS application and its corresponding standards. This advisory focuses on ...
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75 FR 17701 - High Energy Physics Advisory Panel
2010-04-07
... DEPARTMENT OF ENERGY High Energy Physics Advisory Panel AGENCY: Department of Energy, Office of... Physics Advisory Panel (HEPAP). Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires... Energy Physics Advisory Panel; U.S. Department of Energy; SC-25/ Germantown Building, 1000 Independence...
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2012-09-11
... Committee; Earth Science Subcommittee; Applied Sciences Advisory Group Meeting AGENCY: National Aeronautics... the Applied Science Advisory Group. This Subcommittee reports to the Earth Science Subcommittee... following topics: --Applied Sciences Program Update --Earth Science Data Latency Study Preliminary Update...
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Usefulness of [18F]-DA and [18F]-DOPA for PET imaging in a mouse model of pheochromocytoma
International Nuclear Information System (INIS)
Martiniova, Lucia; Cleary, Susannah; Lai, Edwin W.; Kiesewetter, Dale O.; Seidel, Jurgen; Dawson, Linda F.; Phillips, Jacqueline K.; Thomasson, David; Chen Xiaoyuan; Eisenhofer, Graeme; Powers, James F.; Kvetnansky, Richard
2012-01-01
Purpose: To evaluate the usefulness of [ 18 F]-6-fluorodopamine ([ 18 F]-DA) and [ 18 F]-L-6-fluoro-3,4-dihydroxyphenylalanine ([ 18 F]-DOPA) positron emission tomography (PET) in the detection of subcutaneous (s.c.) and metastatic pheochromocytoma in mice; to assess the expression of the norepinephrine transporter (NET) and vesicular monoamine transporters 1 and 2 (VMAT1 and VMAT2), all important for [ 18 F]-DA and [ 18 F]-DOPA uptake. Furthermore, to compare tumor detection by micro-computed tomography (microCT) to magnetic resonance imaging (MRI) in individual mouse. Methods: SUV max values were calculated from [ 18 F]-DA and [ 18 F]-DOPA PET, tumor-to-liver ratios (TLR) were obtained and expression of NET, VMAT1 and VMAT2 was evaluated. Results: [ 18 F]-DA detected less metastatic lesions compared to [ 18 F]-DOPA. TLR values for liver metastases were 2.26–2.71 for [ 18 F]-DOPA and 1.83–2.83 for [ 18 F]-DA. A limited uptake of [ 18 F]-DA was found in s.c. tumors (TLR=0.22-0.27) compared to [ 18 F]-DOPA (TLR=1.56-2.24). Overall, NET and VMAT2 were expressed in all organ and s.c. tumors. However, s.c. tumors lacked expression of VMAT1. We confirmed [ 18 F]-DA's high affinity for the NET for its uptake and VMAT1 and VMAT2 for its storage and retention in pheochromocytoma cell vesicles. In contrast, [ 18 F]-DOPA was found to utilize only VMAT2. Conclusion: MRI was superior in the detection of all organ tumors compared to microCT and PET. [ 18 F]-DOPA had overall better sensitivity than [ 18 F]-DA for the detection of metastases. Subcutaneous tumors were localized only with [ 18 F]-DOPA, a finding that may reflect differences in expression of VMAT1 and VMAT2, perhaps similar to some patients with pheochromocytoma where [ 18 F]-DOPA provides better visualization of lesions than [ 18 F]-DA.
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Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.
Sage, Adam; Blalock, Susan J; Carpenter, Delesha
This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.
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Beach Advisory and Closing Online Notification (BEACON) system
Beach Advisory and Closing Online Notification system (BEACON) is a colletion of state and local data reported to EPA about beach closings and advisories. BEACON is the public-facing query of the Program tracking, Beach Advisories, Water quality standards, and Nutrients database (PRAWN) which tracks beach closing and advisory information.
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76 FR 21877 - Environmental Management Advisory Board
2011-04-19
... DEPARTMENT OF ENERGY Environmental Management Advisory Board AGENCY: Department of Energy. ACTION: Notice of call for nominations for appointment to the Environmental Management Advisory Board. SUMMARY... Environmental Management Advisory Board. DATES: Nominations will be accepted through May 13, 2011. ADDRESSES...
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77 FR 19300 - National Infrastructure Advisory Council
2012-03-30
... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2012-0012] National Infrastructure Advisory... an open Federal Advisory Committee meeting. SUMMARY: The National Infrastructure Advisory Council... business. For additional information, please consult the NIAC Web site, www.dhs.gov/NIAC , or contact the...
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FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.
James, J S
1998-03-06
The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.
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2012-03-02
... for the implementation of best business practices to improve Federal Government management and... performance management, Senior Executive Service (SES) leadership development and SES performance appraisal... President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY...
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78 FR 40487 - National Infrastructure Advisory Council
2013-07-05
... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2013-0033] National Infrastructure Advisory... an open Federal Advisory Committee Meeting. SUMMARY: The National Infrastructure Advisory Council..., from 1:30 p.m. to 4:30 p.m. The meeting may close early if the committee has completed its business...
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Fisher, Neyman, and Bayes at FDA.
Rubin, Donald B
2016-01-01
The wise use of statistical ideas in practice essentially requires some Bayesian thinking, in contrast to the classical rigid frequentist dogma. This dogma too often has seemed to influence the applications of statistics, even at agencies like the FDA. Greg Campbell was one of the most important advocates there for more nuanced modes of thought, especially Bayesian statistics. Because two brilliant statisticians, Ronald Fisher and Jerzy Neyman, are often credited with instilling the traditional frequentist approach in current practice, I argue that both men were actually seeking very Bayesian answers, and neither would have endorsed the rigid application of their ideas.
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2012-06-26
... for the implementation of best business practices to improve Federal Government management and... management, IT vendor performance management, Senior Executive Service (SES) leadership development and SES... President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY...
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Advisory Board on Alcoholism and Drug Abuse
State Employees Advisory Board on Alcoholism and Drug Abuse DHSS State of Alaska Home Divisions and ; Advisory Board on Alcoholism and Drug Abuse Page Content Alison Kulas Executive Director If you, a family Kulas Begins Tenure as Executive Director The Advisory Board on Alcoholism and Drug Abuse, The Alaska
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2011-10-17
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-095)] NASA Advisory Committee; Renewal of NASA's International Space Station Advisory Committee Charter AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the Charter of the International...
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Three Drugs Approved for Urothelial Carcinoma by FDA.
2017-07-01
The FDA has approved one PD-1 checkpoint inhibitor, pembrolizumab, and two PD-L1 checkpoint inhibitors, avelumab and durvalumab, to treat metastatic urothelial carcinoma in patients whose disease continues to progress despite platinum-based chemotherapy. This brings the total number of checkpoint inhibitors for the disease to five, prompting questions about how best to use them. ©2017 American Association for Cancer Research.
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2012-01-19
... Business Enterprise: Meeting of the National Advisory Council on Minority Business Enterprise AGENCY.... SUMMARY: The National Advisory Council for Minority Business Enterprise (NACMBE) will hold its fifth... deliberate on possible recommendations. The Subcommittee topics include: (1) Definition of Minority Business...
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National Atmospheric Release Advisory Center (NARAC) Capabilities for Homeland Security
Energy Technology Data Exchange (ETDEWEB)
Sugiyama, G; Nasstrom, J; Baskett, R; Simpson, M
2010-03-08
The Department of Energy's National Atmospheric Release Advisory Center (NARAC) provides critical information during hazardous airborne releases as part of an integrated national preparedness and response strategy. Located at Lawrence Livermore National Laboratory, NARAC provides 24/7 tools and expert services to map the spread of hazardous material accidentally or intentionally released into the atmosphere. NARAC graphical products show affected areas and populations, potential casualties, and health effect or protective action guideline levels. LLNL experts produce quality-assured analyses based on field data to assist decision makers and responders. NARAC staff and collaborators conduct research and development into new science, tools, capabilities, and technologies in strategically important areas related to airborne transport and fate modeling and emergency response. This paper provides a brief overview of some of NARAC's activities, capabilities, and research and development.
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Leonard, Elizabeth Weeks
2009-01-01
On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.
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42 CFR 90.9 - Public health advisory.
2010-10-01
... 42 Public Health 1 2010-10-01 2010-10-01 false Public health advisory. 90.9 Section 90.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES HEALTH ASSESSMENTS AND HEALTH... PROCEDURES § 90.9 Public health advisory. ATSDR may issue a public health advisory based on the findings of a...
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1995-02-01
The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.
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Smart, Brian A
2009-01-01
The US Food and Drug Administration (FDA) has launched an investigation into the safety of long-acting beta(2)-agonists (LABAs). While the impact of this investigation is yet to be seen, clinicians should be circumspect in the use of these agents and prescribe them according to the recommendations of current asthma guidelines, informing patients and their caretakers about potential risks. As clinical trials attempt to address the question of whether LABAs are safe for use in pediatric and adult populations, current data provide no clear answers. A special hearing of the FDA's Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and Pediatric Advisory Committee attempted to seek consensus on the matter as it reviewed the results of controlled clinical trials and conducted a benefit:risk assessment of LABAs to make recommendations on their safety.
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76 FR 62455 - Aerospace Safety Advisory Panel; Meeting
2011-10-07
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-088)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Burch, Aerospace Safety Advisory Panel Administrative Officer, National Aeronautics and Space...
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78 FR 1265 - Aerospace Safety Advisory Panel; Meeting
2013-01-08
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-001] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel..., Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...
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76 FR 19147 - Aerospace Safety Advisory Panel; Meeting.
2011-04-06
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-030)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel.... Kathy Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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78 FR 56941 - Aerospace Safety Advisory Panel; Meeting
2013-09-16
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-114] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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77 FR 25502 - Aerospace Safety Advisory Panel; Meeting
2012-04-30
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-030)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel... FURTHER INFORMATION CONTACT: Ms. Harmony Myers, Aerospace Safety Advisory Panel Executive Director...
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77 FR 38090 - Aerospace Safety Advisory Panel; Meeting.
2012-06-26
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-044] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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75 FR 61219 - Aerospace Safety Advisory Panel; Meeting
2010-10-04
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-116)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...
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77 FR 58413 - Aerospace Safety Advisory Panel; Meeting
2012-09-20
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-074] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...
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2011-10-18
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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2012-09-17
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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2012-02-07
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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2013-04-10
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...
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75 FR 6407 - Aerospace Safety Advisory Panel; Meeting
2010-02-09
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10- 020)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel... FURTHER INFORMATION CONTACT: Ms. Kathy Dakon, Aerospace Safety Advisory Panel Executive Director, National...
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2010-03-24
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel And Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S. Department of Commerce. ACTION: Notice of an open meeting. SUMMARY: The U.S. Travel and Tourism Advisory...
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2010-04-01
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... Tourism Advisory Board (Board) will hold a meeting to discuss topics related to the travel and tourism...
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2010-07-09
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S. Department of Commerce. ACTION: Notice of an open meeting. SUMMARY: The U.S. Travel and Tourism Advisory...
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77 FR 56242 - Dodd-Frank Investor Advisory Committee
2012-09-12
... Investor Advisory Committee AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of Securities and Exchange Commission Dodd- Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall...
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78 FR 43254 - Dodd-Frank Investor Advisory Committee
2013-07-19
... Investor Advisory Committee AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of Securities and Exchange Commission Dodd- Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall...
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78 FR 20156 - Dodd-Frank Investor Advisory Committee
2013-04-03
... Investor Advisory Committee AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of Securities and Exchange Commission Dodd- Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall...
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78 FR 2706 - Dodd-Frank Investor Advisory Committee
2013-01-14
... Investor Advisory Committee AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of Securities and Exchange Commission Dodd- Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall...
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78 FR 36793 - Aerospace Safety Advisory Panel; Meeting
2013-06-19
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-068] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel..., Huntsville, AL 35805 FOR FURTHER INFORMATION CONTACT: Ms. Harmony Myers, Aerospace Safety Advisory Panel...
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2011-07-11
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9435-3] Notification of Public Teleconferences of the Science... Protection Agency (EPA), Science Advisory Board Staff Office. ACTION: Notice. SUMMARY: The EPA Science... information concerning the EPA Science Advisory Board can be found at the EPA SAB Web site at http// www.epa...
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Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael
2013-01-22
The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5
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2011-10-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
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Bastiaans, D.E.T.; Forcat, S.; Lyall, H.; Cressey, T.R.; Hansudewechakul, R.; Kanjanavanit, S.; Noguera-Julian, A.; Konigs, C.; Inshaw, J.R.; Chalermpantmetagul, S.; Saidi, Y.; Compagnucci, A.; Harper, L.M.; Giaquinto, C.; Colbers, A.P.; Burger, D.M.
2014-01-01
BACKGROUND: Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval
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Huang, Fanghua
2010-04-01
Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine.
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2011-01-28
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Committee on Diversity for Communications in the Digital Age (``Diversity Committee''). ADDRESSES: A copy of...
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MedWatch, the FDA Safety Information and Adverse Event Reporting Program
... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it ... approved information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety ...
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2010-12-21
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...
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2011-04-18
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...
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2011-08-29
... DEPARTMENT OF COMMERCE International Trade Administration U.S. Travel and Tourism Advisory Board: Meeting of the U.S. Travel and Tourism Advisory Board AGENCY: International Trade Administration, U.S... agenda for an open meeting of the U.S. Travel and Tourism Advisory Board (Board). The agenda may change...
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77 FR 29705 - Dodd-Frank Investor Advisory Committee
2012-05-18
... Investor Advisory Committee AGENCY: Securities and Exchange Commission. ACTION: Notice of First Meeting of Securities and Exchange Commission Dodd-Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall...
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78 FR 15937 - Fusion Energy Sciences Advisory Committee
2013-03-13
... DEPARTMENT OF ENERGY Fusion Energy Sciences Advisory Committee AGENCY: Department of Energy, Office of Science. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Fusion Energy Sciences Advisory Committee. The Federal Advisory Committee Act requires that public notice of...
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77 FR 5246 - Basic Energy Sciences Advisory Committee
2012-02-02
... DEPARTMENT OF ENERGY Basic Energy Sciences Advisory Committee AGENCY: Office of Science... of the Basic Energy Sciences Advisory Committee (BESAC). The Federal Advisory Committee Act (Pub. L... FURTHER INFORMATION CONTACT: Katie Perine; Office of Basic Energy Sciences; U.S. Department of Energy...
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78 FR 2259 - Fusion Energy Sciences Advisory Committee
2013-01-10
... DEPARTMENT OF ENERGY Fusion Energy Sciences Advisory Committee AGENCY: Office of Science... Energy Sciences Advisory Committee. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770... Energy Sciences; U.S. Department of Energy; 1000 Independence Avenue SW.; Washington, DC 20585-1290...
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77 FR 70807 - Advisory Board for Exceptional Children
2012-11-27
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...
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76 FR 40929 - Advisory Board for Exceptional Children
2011-07-12
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...
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77 FR 47873 - Advisory Board for Exceptional Children
2012-08-10
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...
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75 FR 50780 - Advisory Board for Exceptional Children
2010-08-17
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...
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Directory of Open Access Journals (Sweden)
Gilhyang Kim
2016-11-01
Full Text Available Background Human epidermal growth factor receptor 2 (HER2 is one of the known oncogenes in urothelial carcinoma. However, the association between HER2 and the prognosis of upper urinary tract urothelial carcinoma (UUTUC has not yet been fully clarified. The aim of this study was to evaluate HER2 expression using the United States Food and Drug Administration (FDA criteria and American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP criteria and compare their prognostic significance in UUTUC. Methods HER2 expression was evaluated in 144 cases of UUTUC by immunohistochemistry (IHC using tissue microarrays. We separately analyzed HER2 expression using the FDA and ASCO/CAP criteria. The IHC results were categorized into low (0, 1+ and high (2+, 3+ groups. Results Using the FDA criteria, 94 cases were negative, 38 cases were 1+, nine cases were 2+, and three cases were 3+. Using the ASCO/CAP criteria, 94 cases were negative, 34 cases were 1+, 13 cases were 2+, and three cases were 3+. Four cases showing 2+ according to the ASCO/CAP criteria were reclassified as 1+ by the FDA criteria. High HER2 expression by both the FDA criteria and ASCO/CAP criteria was significantly associated with International Society of Urological Pathology high grade (p = .001 and p < .001. The high HER2 expression group classified with the FDA criteria showed significantly shorter cancer-specific survival (p = .004, but the HER2 high and low expression groups classified with the ASCO/CAP criteria did not show significant differences (p = .161 in cancer-specific survival. Conclusions HER2 high expression groups were significantly associated with shorter cancer-specific survival, and our study revealed that the FDA criteria are more suitable for determining HER2 expression in UUTUC.
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2010-11-16
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee'') will hold a meeting on Thursday, December 2, 2010 at...
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2010-09-30
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee'') will hold a meeting on Thursday, October 14, 2010 at...
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2010-09-01
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee'') will hold a meeting on Tuesday, September 21, 2010 at...
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Directory of Open Access Journals (Sweden)
Gil Amarilyo
Full Text Available Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA which independently analyzes the raw data and reports the results on its website.This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis.Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy and withdrawal due to adverse events (safety. As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report, followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy.FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34 except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61 pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55 pairwise comparisons and were statistically significant in 5. The "signal" in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical.There was no empirical evidence to suggest biased estimates between the two
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Timelines of translational science: From technology initiation to FDA approval.
Directory of Open Access Journals (Sweden)
Laura M McNamee
Full Text Available While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p<0.0005. Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.
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FDA, CE mark or something else?-Thinking fast and slow.
Mishra, Sundeep
There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.
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Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review
Directory of Open Access Journals (Sweden)
Juan Carlos Martínez-Aguayo
2016-06-01
Full Text Available ABSTRACT Background The United States Food and Drug Administration (FDA has warned about the increased suicidality risk associated with the use of selective serotonin reuptake inhibitors (SSRI and venlafaxine in children and adolescents. Objectives To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents. Methods A critical review of articles in Medline/PubMed and SciELO databases regarding the FDA Black box warning for antidepressants, and the impact of FDA warnings on antidepressant prescriptions and suicide rates. Results The warning was based on surveys that did not report either cases of suicide nor a significant difference supporting an increased suicidality rate. The concept was defined in an ambiguous way and there is currently more available evidence to support such definition. The use of SSRI and venlafaxine has been associated to lower suicidality rates, but the prescription fall due to the warning increased suicide rates. Discussion Suicidality is an inherent feature of depressive disorders so it would be desirable to consider how much of the phenomenon may be attributed to antidepressants per se. It would be appropriate to consider that suicide rates might increase also as a consequence of the warning.
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76 FR 48147 - Basic Energy Sciences Advisory Committee
2011-08-08
... DEPARTMENT OF ENERGY Basic Energy Sciences Advisory Committee AGENCY: Department of Energy, Office of Science. ACTION: Notice of renewal of the Basic Energy Sciences Advisory Committee. SUMMARY... that the Basic Energy Sciences Advisory Committee will be renewed for a two-year period beginning July...
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75 FR 6369 - Basic Energy Sciences Advisory Committee
2010-02-09
... DEPARTMENT OF ENERGY Basic Energy Sciences Advisory Committee AGENCY: Department of Energy, Office of Science. ACTION: Notice of Open Meeting. SUMMARY: This notice announces a meeting of the Basic Energy Sciences Advisory Committee (BESAC). Federal Advisory Committee Act (Pub. L. 92- 463, 86 Stat. 770...
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75 FR 8685 - Fusion Energy Sciences Advisory Committee
2010-02-25
... DEPARTMENT OF ENERGY Fusion Energy Sciences Advisory Committee AGENCY: Department of Energy, Office of Science. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Fusion Energy Sciences Advisory Committee. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770...
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76 FR 41234 - Basic Energy Sciences Advisory Committee
2011-07-13
... DEPARTMENT OF ENERGY Basic Energy Sciences Advisory Committee AGENCY: Department of Energy, Office of Science. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Basic Energy Sciences Advisory Committee (BESAC). Federal Advisory Committee Act (Pub. L. 92- 463, 86 Stat. 770...
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78 FR 38696 - Basic Energy Sciences Advisory Committee
2013-06-27
... DEPARTMENT OF ENERGY Basic Energy Sciences Advisory Committee AGENCY: Department of Energy, Office of Science. ACTION: Notice of Open Meeting. SUMMARY: This notice announces a meeting of the Basic Energy Sciences Advisory Committee (BESAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat...
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78 FR 6088 - Basic Energy Sciences Advisory Committee
2013-01-29
... DEPARTMENT OF ENERGY Basic Energy Sciences Advisory Committee AGENCY: Office of Science... Energy Sciences Advisory Committee (BESAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat... INFORMATION CONTACT: Katie Perine, Office of Basic Energy Sciences, U.S. Department of Energy; SC-22...
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77 FR 41395 - Basic Energy Sciences Advisory Committee
2012-07-13
... DEPARTMENT OF ENERGY Basic Energy Sciences Advisory Committee AGENCY: Department of Energy, Office of Science. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Basic Energy Sciences Advisory Committee (BESAC). Federal Advisory Committee Act (Pub. L. 92- 463, 86 Stat. 770...
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76 FR 8358 - Basic Energy Sciences Advisory Committee
2011-02-14
... DEPARTMENT OF ENERGY Basic Energy Sciences Advisory Committee AGENCY: Department of Energy, Office of Science. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Basic Energy Sciences Advisory Committee (BESAC). Federal Advisory Committee Act (Pub. L. 92- 463, 86 Stat. 770...
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76 FR 40714 - Fusion Energy Sciences Advisory Committee
2011-07-11
... DEPARTMENT OF ENERGY Fusion Energy Sciences Advisory Committee AGENCY: Department of Energy, Office of Science. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Fusion Energy Sciences Advisory Committee. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770...
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77 FR 16062 - Advisory Board for Exceptional Children
2012-03-19
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... Individuals with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...
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77 FR 28897 - Advisory Board for Exceptional Children
2012-05-16
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... Individuals with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...
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76 FR 17965 - Advisory Board for Exceptional Children
2011-03-31
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... Individuals with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...
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75 FR 82410 - Advisory Board for Exceptional Children
2010-12-30
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... (BIE) is announcing that the Advisory Board for Exceptional Children (Advisory Board) will hold its... Individuals with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. DATES: The...
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75 FR 53334 - Advisory Board for Exceptional Children
2010-08-31
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY: Bureau of Indian Affairs, Interior. ACTION: Notice of meeting; correction. SUMMARY: The Bureau of Indian... Advisory Board for Exceptional Children (Advisory Board) will hold its next meeting in Washington, DC. The...
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2010-04-21
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee'') will hold a meeting on Tuesday, June 15, 2010 at 2:00...
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2010-02-05
... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee'') will hold a meeting on Wednesday, March 24, 2010 at 2...
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Zimmerman, Mark
2016-06-01
According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored. © The Royal College of Psychiatrists 2016.
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... in Select Bottles of Muscle Strength and Nighttime Recovery Product Because of Undeclared Milk Allergen on The Label ( FDA 04/06/18 ) Independent Nutrition, Inc Issues Allergy Alert On Undeclared Milk in ...
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77 FR 42298 - Biomass Research and Development Technical Advisory Committee
2012-07-18
... Biomass Research and Development Technical Advisory Committee (Technical Advisory Committee). DATES: The... 9008(d) established the Biomass Research and Development Technical Advisory Committee and lays forth... nomination. Appointments to the Biomass Research and Development Technical Advisory Committee will be made by...
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75 FR 73166 - Art Advisory Panel-Closed Meeting
2010-11-29
... DEPARTMENT OF THE TREASURY Internal Revenue Service Art Advisory Panel--Closed Meeting AGENCY: Internal Revenue Service, Treasury. ACTION: Notice of Closed Meeting of Art Advisory Panel for Decorative Art. SUMMARY: A closed meeting of the Art Advisory Panel will be held in Washington, DC. DATES: The...
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78 FR 42105 - Advisory Board for Exceptional Children
2013-07-15
....97C22214.001] Advisory Board for Exceptional Children AGENCY: Bureau of Indian Affairs, Interior. ACTION... for Exceptional Children (Advisory Board) will hold its next meeting in Albuquerque, New Mexico. The... (IDEA) for Indian children with disabilities. DATES: The Advisory Board will meet on Thursday, July 18...
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Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.
Bradford, W David; Kleit, Andrew N
2015-07-01
Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. Copyright © 2014 John Wiley & Sons, Ltd.
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75 FR 63450 - DOE/NSF High Energy Physics Advisory Panel
2010-10-15
... DEPARTMENT OF ENERGY DOE/NSF High Energy Physics Advisory Panel AGENCY: Department of Energy.../NSF High Energy Physics Advisory Panel (HEPAP). Federal Advisory Committee Act (Pub. L. 92-463, 86... 20852. FOR FURTHER INFORMATION CONTACT: John Kogut, Executive Secretary; High Energy Physics Advisory...
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2013-03-05
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9786-6] Notification of a Public Meeting of the Science...: Notice. SUMMARY: The Environmental Protection Agency (EPA or agency) Science Advisory Board (SAB) Staff Office announces a public meeting of the SAB Chemical Assessment Advisory Committee (CAAC) to receive a...
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75 FR 23288 - Advisory Board for Exceptional Children
2010-05-03
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY... Exceptional Children (Advisory Board) will hold its next meeting in Old Town, Maine. The purpose of the... Indian children with disabilities. DATES: The Advisory Board will meet on Monday, May 17, 2010, from 8:30...
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77 FR 64799 - DOE/NSF High Energy Physics Advisory Panel
2012-10-23
... DEPARTMENT OF ENERGY DOE/NSF High Energy Physics Advisory Panel AGENCY: Department of Energy... Physics Advisory Panel (HEPAP). Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires... Kogut, Executive Secretary; High Energy Physics Advisory Panel; U.S. Department of Energy; SC-25...
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78 FR 46330 - DOE/NSF High Energy Physics Advisory Panel
2013-07-31
... DEPARTMENT OF ENERGY DOE/NSF High Energy Physics Advisory Panel AGENCY: Office of Science... High Energy Physics Advisory Panel (HEPAP). Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat... CONTACT: John Kogut, Executive Secretary; High Energy Physics Advisory Panel; U.S. Department of Energy...
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76 FR 19986 - DOE/NSF High Energy Physics Advisory Panel
2011-04-11
... DEPARTMENT OF ENERGY DOE/NSF High Energy Physics Advisory Panel AGENCY: Department of Energy.../NSF High Energy Physics Advisory Panel (HEPAP). The Federal Advisory Committee Act (Pub. L. 92-463, 86... FURTHER INFORMATION CONTACT: John Kogut, Executive Secretary; High Energy Physics Advisory Panel; U.S...
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FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR
An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing. Br
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Yang, Tubao; Walker, Mark C; Krewski, Daniel; Yang, Qiuying; Nimrod, Carl; Garner, Peter; Fraser, William; Olatunbosun, Olufemi; Wen, Shi Wu
2008-03-01
To estimate the frequency of exposure to prescription Food and Drug Administration (FDA) category C, D, and X drugs in pregnant women, and to analyze the maternal characteristics associated with such an exposure. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 was chosen for the study. The rate of exposure to FDA category C, D, or X drugs recorded in the pharmacist database was estimated. Associations of exposure to FDA category C, D, and X drugs with maternal characteristics were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 575 women were included in this study. Among them, 3604 (19.4%) had exposure to one or more FDA category C, D, and X drugs during pregnancy. Category C drugs were the most frequently used drugs (15.8%), followed by D drugs (5.2%), and X drugs (3.9%). Women with chronic health conditions had fourfold at increased risk of exposure than women without. Regardless of health status, women who were or =3, and who were on social assistance plan were at increased risk of pregnancy exposure to these drugs. About 19.4% pregnant women are exposed to FDA C, D or X drugs during pregnancy. Women with chronic diseases, younger age, increased parity, and under social assistance are at increased risk of exposure to FDA C, D, or X drugs. Copyright 2008 John Wiley & Sons, Ltd.
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Advisory and autonomous cooperative driving systems
Broek, T.H.A. van den; Ploeg, J.; Netten, B.D.
2011-01-01
In this paper, the traffic efficiency of an advisory cooperative driving system, Advisory Acceleration Control is examined and compared to the efficiency of an autonomous cooperative driving system, Cooperative Adaptive Cruise Control. The algorithms and implementation thereof are explained. The
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FDA Developments: Food Code 2013 and Proposed Trans Fat Determination
Grossman, M.R.
2014-01-01
268 Reports EFFL 4|2014 USA FDA Developments: Food Code 2013 and Proposed Trans Fat Determination Margaret Rosso Grossman* I. Food Code 2013 and Food Code Reference System Since 1993, the US Food and Drug Administration has published a Food Code, now updated every four years. In November 2013, the
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78 FR 69839 - DOE/NSF High Energy Physics Advisory Panel
2013-11-21
... DEPARTMENT OF ENERGY DOE/NSF High Energy Physics Advisory Panel AGENCY: Department of Energy.../NSF High Energy Physics Advisory Panel (HEPAP). The Federal Advisory Committee Act (Pub. L. 92-463, 86... CONTACT: John Kogut, Executive Secretary; High Energy Physics Advisory Panel; U.S. Department of Energy...
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78 FR 12043 - DOE/NSF High Energy Physics Advisory Panel
2013-02-21
... DEPARTMENT OF ENERGY DOE/NSF High Energy Physics Advisory Panel AGENCY: Office of Science... High Energy Physics Advisory Panel (HEPAP). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat... INFORMATION CONTACT: John Kogut, Executive Secretary; High Energy Physics Advisory Panel; U.S. Department of...
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75 FR 57463 - DOE/NSF High Energy Physics Advisory Panel
2010-09-21
... DEPARTMENT OF ENERGY DOE/NSF High Energy Physics Advisory Panel AGENCY: Department of Energy.../NSF High Energy Physics Advisory Panel (HEPAP). Federal Advisory Committee Act (Pub. L. 92-463, 86... Secretary; High Energy Physics Advisory Panel; U.S. Department of Energy; SC-25/ Germantown Building, 1000...
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77 FR 4027 - DOE/NSF High Energy Physics Advisory Panel
2012-01-26
... DEPARTMENT OF ENERGY DOE/NSF High Energy Physics Advisory Panel AGENCY: Department of Energy.../NSF High Energy Physics Advisory Panel (HEPAP). The Federal Advisory Committee Act (Pub. L. 92-463, 86... Secretary; High Energy Physics Advisory Panel; U.S. Department of Energy; SC-25/ Germantown Building, 1000...
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77 FR 33449 - DOE/NSF High Energy Physics Advisory Panel
2012-06-06
... DEPARTMENT OF ENERGY DOE/NSF High Energy Physics Advisory Panel AGENCY: Office of Science... High Energy Physics Advisory Panel (HEPAP). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat..., Executive Secretary; High Energy Physics Advisory Panel; U.S. Department of Energy; SC-25/ Germantown...
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76 FR 41234 - DOE/NSF High Energy Physics Advisory Panel
2011-07-13
... DEPARTMENT OF ENERGY DOE/NSF High Energy Physics Advisory Panel AGENCY: Department of Energy.../NSF High Energy Physics Advisory Panel (HEPAP). The Federal Advisory Committee Act (Pub. L. 92-463, 86... Secretary; High Energy Physics Advisory Panel; U.S. Department of Energy; SC-25/ Germantown Building, 1000...
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76 FR 8358 - DOE/NSF High Energy Physics Advisory Panel
2011-02-14
... DEPARTMENT OF ENERGY DOE/NSF High Energy Physics Advisory Panel AGENCY: Department of Energy.../NSF High Energy Physics Advisory Panel (HEPAP). Federal Advisory Committee Act (Pub. L. 92-463, 86... Secretary; High Energy Physics Advisory Panel; U.S. Department of Energy; SC-25/ Germantown Building, 1000...
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Klara, Kristina; Kim, Jeanie; Ross, Joseph S
2018-05-01
Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.
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2013-11-26
... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2009-0203] Pipeline Safety: Meeting of the Gas Pipeline Advisory Committee and the Liquid Pipeline Advisory Committee AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. [[Page...
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America, you are digging your grave with your spoon--should the FDA tell you that on food labels?
Card, Melissa M
2013-01-01
R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.
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Pouwels, Koen; Van Grootheest, Kees
2013-01-01
The rosiglitazone decision process at FDA and EMA. What should we learn? In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone while the FDA decided to restrict its use. These actions were taken because rosiglitazone had been associated with an increased risk of
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Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?
Rosania, Larry
2010-01-01
Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.
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FDA drug safety communications: a narrative review and clinical considerations for older adults.
Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A
2012-08-01
The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older
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75 FR 6651 - Biological and Environmental Research Advisory Committee
2010-02-10
... DEPARTMENT OF ENERGY Biological and Environmental Research Advisory Committee AGENCY: Department... meeting of the Biological and Environmental Research Advisory Committee (BERAC). Federal Advisory.... Department of Energy, Office of Science, Office of Biological and Environmental Research, SC-23/Germantown...
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Quantitative risk assessment of foods containing peanut advisory labeling.
Remington, Benjamin C; Baumert, Joseph L; Marx, David B; Taylor, Steve L
2013-12-01
Foods with advisory labeling (i.e. "may contain") continue to be prevalent and the warning may be increasingly ignored by allergic consumers. We sought to determine the residual levels of peanut in various packaged foods bearing advisory labeling, compare similar data from 2005 and 2009, and determine any potential risk for peanut-allergic consumers. Of food products bearing advisory statements regarding peanut or products that had peanut listed as a minor ingredient, 8.6% and 37.5% contained detectable levels of peanut (>2.5 ppm whole peanut), respectively. Peanut-allergic individuals should be advised to avoid such products regardless of the wording of the advisory statement. Peanut was detected at similar rates and levels in products tested in both 2005 and 2009. Advisory labeled nutrition bars contained the highest levels of peanut and an additional market survey of 399 products was conducted. Probabilistic risk assessment showed the risk of a reaction to peanut-allergic consumers from advisory labeled nutrition bars was significant but brand-dependent. Peanut advisory labeling may be overused on some nutrition bars but prudently used on others. The probabilistic approach could provide the food industry with a quantitative method to assist with determining when advisory labeling is most appropriate. Copyright © 2013 Elsevier Ltd. All rights reserved.
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Alaslai, Nasser Y.
2016-01-05
The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.
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Alaslai, Nasser Y.; Ghanem, Bader; Alghunaimi, Fahd; Litwiller, Eric; Pinnau, Ingo
2016-01-01
The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.
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A Good Year: FDA Approved Nine New Cancer Drugs in 2014
In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.
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Krahn, Andrew D; Simpson, Christopher S; Parkash, Ratika; Yee, Raymond; Champagne, Jean; Healey, Jeffrey S; Cameron, Doug; Thibault, Bernard; Mangat, Iqwal; Tung, Stanley; Sterns, Laurence; Birnie, David H; Exner, Derek V; Sivakumaran, Soori; Davies, Ted; Coutu, Benoit; Crystal, Eugene; Wolfe, Kevin; Verma, Atul; Stephenson, Elizabeth A; Sanatani, Shubhayan; Gow, Robert; Connors, Sean; Paredes, Felix Ayala; Turabian, Mike; Kus, Teresa; Essebag, Vidal; Gardner, Martin
2009-01-01
The Canadian Heart Rhythm Society (CHRS) Device Advisory Committee was commissioned to respond to advisories regarding cardiac rhythm device and lead performance on behalf of the CHRS. In the event of an advisory, the Chair uses an e-mail network to disseminate advisory information to Committee members broadly representative of the Canadian device community. A consensus recommendation is prepared by the Committee and made available to all Canadian centres on the CHRS Web site after approval by the CHRS executive. This collaborative approach using an e-mail network has proven very efficient in providing a rapid national response to device advisories. The network is an ideal tool to collect specific data on implanted device system performance and allows for prompt reporting of clinically relevant data to front-line clinicians and patients. PMID:19584969
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78 FR 57174 - Advisory Committee Meeting
2013-09-17
... recommended for inclusion on future Joint Board examinations in actuarial mathematics, pension law and... Advisory Committee on Actuarial Examinations. DATES: The meeting will be held on October 18, 2013, from 8.... SUPPLEMENTARY INFORMATION: Notice is hereby given that the Advisory Committee on Actuarial Examinations will...
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78 FR 68887 - Dodd-Frank Investor Advisory Committee; Meeting
2013-11-15
... Investor Advisory Committee; Meeting AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of Securities and Exchange Commission Dodd- Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the...
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78 FR 6087 - Biological and Environmental Research Advisory Committee
2013-01-29
... DEPARTMENT OF ENERGY Biological and Environmental Research Advisory Committee AGENCY: Office of... the Biological and Environmental Research Advisory Committee (BERAC). The Federal Advisory Committee... Federal Officer, BERAC, U.S. Department of Energy, Office of Science, Office of Biological and...
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77 FR 4028 - Biological and Environmental Research Advisory Committee
2012-01-26
... DEPARTMENT OF ENERGY Biological and Environmental Research Advisory Committee AGENCY: Department... meeting of the Biological and Environmental Research Advisory Committee (BERAC). The Federal Advisory.... Department of Energy, Office of Science, Office of Biological and Environmental Research, SC-23/Germantown...
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76 FR 1130 - Prince William Sound Resource Advisory Committee
2011-01-07
... DEPARTMENT OF AGRICULTURE Forest Service Prince William Sound Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Prince William Sound Resource Advisory... conducted: The Prince William Sound Resource Advisory Committee (RAC) will be discussing and voting on...
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77 FR 45331 - Prince William Sound Resource Advisory Committee
2012-07-31
... DEPARTMENT OF AGRICULTURE Forest Service Prince William Sound Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Prince William Sound Resource Advisory... Prince William Sound Resource Advisory Committee (RAC) will be discussing and voting on proposals that...
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75 FR 29781 - President's National Security Telecommunications Advisory Committee
2010-05-27
...] President's National Security Telecommunications Advisory Committee AGENCY: National Protection and Programs... Security Telecommunications Advisory Committee (NSTAC) will be meeting by teleconference; the meeting will... telecommunications policy. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), Public...
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Esterly, John S; Steadman, Emily; Scheetz, Marc H
2011-06-01
In September 2007, the FDA issued an alert recommending that ceftriaxone and calcium-containing solutions should not be administered to any patient within 48 h of each other. Due to the widespread use of ceftriaxone, significant concern was expressed by the greater healthcare community about the warning, which the FDA eventually retracted in April of 2009. We sought to quantify the impact of the warning on healthcare institutions. A survey was administered to the membership of the Society of Infectious Diseases Pharmacists to quantify perceived changes in ceftriaxone use among healthcare institutions across the United States. A survey of Infectious Diseases experts was conducted. Participants were queried for hospital policies/drug use statistics during two times: immediately after the FDA warning and approximately 13 months post warning (preceding the FDA retraction). Related changes in formulary, drug-use policy, and the number of employee hours that were devoted to addressing the FDA warning were assessed. Ninety-four surveys representing 94 hospital systems were included in the analysis. Approximately half (n = 49, 52%) of respondent institutions enacted at least one drug-use policy change based on the warning; one institution removed ceftriaxone from a clinical protocol. Institutions' final interpretations of the warning differed slightly from initial understanding of the warning, and there was an overall minor decrease in the perceived use of ceftriaxone. The majority of those surveyed (n = 70, 74%) estimated that their respective institutions devoted between 1 and 49 employee hours to address the warning. Hospitals with ID pharmacists had minimal changes to ceftriaxone use after the 2007 FDA warning. Specialized pharmacists may be uniquely situated to help hospitals interpret global recommendations locally.
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The advisory list for selvclassification of dangerous substances
DEFF Research Database (Denmark)
Niemelä, Jay Russell; Wedebye, Eva Bay; Nikolov, Nikolai Georgiev
All chemical substances marketed in the EU must be classified and labelled according to the regulation on classification and labelling of dangerous substances (7). Substances with harmonised classifications adopted in the EU are to be found on the List of harmonised classification and labelling...... this issue, the Danish Environmental Protection Agency published the Advisory Self-classification List /5/. This report describes the updating of this list. The Advisory Self-Classification list is created by the use of (Q)SARs ((Quantitative) Structure-Activity Relationships) to predict the effects...... Skin sensitisation The updated advisory list is available as an Excel file for download from DK-EPA's website and as an online searchable database. This includes the 23,922 chemicals with new advisory classifications resulting from this project, making in all, a total of 30,179 chemicals with advisory...
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78 FR 28594 - Advisory Committee Meeting
2013-05-15
... draft competitiveness report, and Ex-Im Bank economic impact policy update. Public Participation: The... EXPORT-IMPORT BANK OF THE UNITED STATES Advisory Committee Meeting ACTION: Notice of Open Meeting of the Advisory Committee of the Export- Import Bank of the United States (Ex-Im Bank). Time and...
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75 FR 16159 - President's National Security Telecommunications Advisory Committee
2010-03-31
...] President's National Security Telecommunications Advisory Committee AGENCY: National Communications System... Telecommunications Advisory Committee (NSTAC) will hold its annual meeting on May 6, 2010. The meeting will be open... preparedness telecommunications policy. Notice of this meeting is given under the Federal Advisory Committee...
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Pelletier, David L
2005-05-01
The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.
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The Problem with Briefs, in Brief
Conaway, Carrie L.
2013-01-01
Policy briefs written by academics--the kind typically published in "Education Finance and Policy"--should be a crucial source of information for policy makers. Yet too frequently these briefs fail to garner the consideration they deserve. Their authors are too focused on the potential objections of their fellow academics, who are…
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76 FR 7869 - Notice of Meeting; Advisory Council on Historic Preservation
2011-02-11
... ADVISORY COUNCIL ON HISTORIC PRESERVATION Notice of Meeting; Advisory Council on Historic Preservation AGENCY: Advisory Council on Historic Preservation. ACTION: Notice of Meeting. Summary: Notice is hereby given that the Advisory Council on Historic Preservation (ACHP) will meet Thursday, February 17...
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75 FR 71135 - Notice of Meeting; Advisory Council on Historic Preservation
2010-11-22
... ADVISORY COUNCIL ON HISTORIC PRESERVATION Notice of Meeting; Advisory Council on Historic Preservation AGENCY: Advisory Council on Historic Preservation. ACTION: Notice of meeting. SUMMARY: Notice is hereby given that the Advisory Council on Historic Preservation (ACHP) will meet Thursday, December 2...
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2013-07-25
... provided to the contact person below in advance of the meeting. Background: The Advisory Board was... President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Advisory Board include providing advice on the...
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75 FR 65447 - Prince of Wales Resource Advisory Committee
2010-10-25
... DEPARTMENT OF AGRICULTURE Forest Service Prince of Wales Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Prince of Wales Resource Advisory Committee... Ranger District 504 9th Street, Craig, Alaska. Send written comments to Prince of Wales Resource Advisory...
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78 FR 73187 - Black Hills National Forest Advisory Board
2013-12-05
... DEPARTMENT OF AGRICULTURE Forest Service Black Hills National Forest Advisory Board AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Black Hills National Forest Advisory Board (Board... all members of the Advisory Board; (2) provide orientation to Board Members on Basic Laws governing...
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Farris, April L
2010-01-01
As of 2009, the "natural foods" industry has become a 22.3 billion dollar giant and "all-natural" is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term "natural" through rulemaking. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term "natural," and FDA has abandoned efforts to define "natural" through rulemaking in the face of more pressing priorities. In absence of any governing federal standard, consumer advocacy groups and warring food industries have attempted to define "natural" to fit their preferences through high-stakes litigation of state law claims, leaving courts free to apply diverging standards without the expertise of FDA. Recent case law from federal district courts and the Supreme Court leaves little hope that FDA's current policy statement will preempt state law causes of action. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rulemaking to define the term "natural." This paper concludes by sketching potential formulations for such a rule based on FDA's previous successful rule-making ventures and standards used by natural foods retailers.
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16 CFR 1018.12 - Statutory advisory committees.
2010-01-01
... Federal Hazardous Substances Act, as amended (Pub. L. 95-631, 92 Stat. 3747, 15 U.S.C. 1275). [46 FR 63248... MANAGEMENT Establishment of Advisory Committees § 1018.12 Statutory advisory committees. The Commission has...
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78 FR 57903 - Aerospace Safety Advisory Panel; Charter Renewal
2013-09-20
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-116] Aerospace Safety Advisory Panel... and amendment of the charter of the Aerospace Safety Advisory Panel. SUMMARY: Pursuant to sections 14... determined that renewal and amendment of the charter of the Aerospace Safety Advisory Panel is in the public...
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76 FR 65750 - Aerospace Safety Advisory Panel; Charter Renewal
2011-10-24
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-105)] Aerospace Safety Advisory Panel... and amendment of the charter of the NASA Aerospace Safety Advisory Panel. SUMMARY: Pursuant to... determined that a renewal and amendment of the charter of the NASA Aerospace Safety Advisory Panel is in the...
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FDA, CE mark or something else?—Thinking fast and slow
Directory of Open Access Journals (Sweden)
Sundeep Mishra
2017-01-01
Full Text Available There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: “substantial equivalence,” “PMDA,” “CE mark,” “Notified body,” “510K” and “PMA” but the actual approval process can also be very tardy, inconsistent and expensive.
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75 FR 6651 - Office of Science; High Energy Physics Advisory Panel
2010-02-10
... DEPARTMENT OF ENERGY Office of Science; High Energy Physics Advisory Panel AGENCY: Department of... Physics Advisory Panel (HEPAP). Federal Advisory Committee Act (Public Law 92- 463, 86 Stat. 770) requires...; High Energy Physics Advisory Panel; U.S. Department of Energy; SC-25/ Germantown Building, 1000...
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Small Area Estimate Maps: Does the FDA Regulate Tobacco? - Small Area Estimates
This metric is defined as a person 18 years of age or older who must have reported that he/she believes that the United States Food and Drug Administration (FDA) regulates tobacco products in the U.S.
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Directory of Open Access Journals (Sweden)
Nguyen Diane
2013-01-01
Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by
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75 FR 82236 - Principal Trades with Certain Advisory Clients
2010-12-30
... 3235-AJ96 Principal Trades with Certain Advisory Clients AGENCY: Securities and Exchange Commission... certain of their advisory clients. The amendment extends the date on which rule 206(3)- 3T will sunset... a principal capacity in transactions with certain of their advisory clients.\\1\\ In December 2009, we...
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77 FR 43064 - Meeting; Technology Advisory Committee
2012-07-23
... customer fund segregation laws, and making false statements in financial statements filed with the... COMMODITY FUTURES TRADING COMMISSION Meeting; Technology Advisory Committee AGENCY: Commodity Futures Trading Commission (CFTC). ACTION: Notice of emergency meeting of technology advisory committee...
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2011-06-23
... Alcohol Abuse and Alcoholism and National Advisory Council on Drug Abuse; Notice of Joint Meeting Pursuant... given of a joint meeting of the National Advisory Council on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse. The meeting will be open to the public as indicated below, with...
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2011-03-10
... a Public Meeting of the Science Advisory Board Committee on Science Integration for Decision Making... Agency (EPA or Agency) Science Advisory Board (SAB) Staff Office announces a public meeting of the SAB Committee on Science Integration for Decision Making. DATES: The meeting dates are March 29, 2011 from 9 a.m...
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Network-Based Real-time Integrated Fire Detection and Alarm (FDA) System with Building Automation
Anwar, F.; Boby, R. I.; Rashid, M. M.; Alam, M. M.; Shaikh, Z.
2017-11-01
Fire alarm systems have become increasingly an important lifesaving technology in many aspects, such as applications to detect, monitor and control any fire hazard. A large sum of money is being spent annually to install and maintain the fire alarm systems in buildings to protect property and lives from the unexpected spread of fire. Several methods are already developed and it is improving on a daily basis to reduce the cost as well as increase quality. An integrated Fire Detection and Alarm (FDA) systems with building automation was studied, to reduce cost and improve their reliability by preventing false alarm. This work proposes an improved framework for FDA system to ensure a robust intelligent network of FDA control panels in real-time. A shortest path algorithmic was chosen for series of buildings connected by fiber optic network. The framework shares information and communicates with each fire alarm panels connected in peer to peer configuration and declare the network state using network address declaration from any building connected in network. The fiber-optic connection was proposed to reduce signal noises, thus increasing large area coverage, real-time communication and long-term safety. Based on this proposed method an experimental setup was designed and a prototype system was developed to validate the performance in practice. Also, the distributed network system was proposed to connect with an optional remote monitoring terminal panel to validate proposed network performance and ensure fire survivability where the information is sequentially transmitted. The proposed FDA system is different from traditional fire alarm and detection system in terms of topology as it manages group of buildings in an optimal and efficient manner.Introduction
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FDA Food Code recommendations: how do popular US baking shows measure up?
Directory of Open Access Journals (Sweden)
Valerie Cadorett
2018-05-01
Full Text Available The purpose of this study was to determine if popular US baking shows follow the FDA Food Code recommendations and critical food safety principles. This cross-sectional study examined a convenience sample of 75 episodes from three popular baking shows. The three shows were about competitively baking cupcakes, competitively baking cakes, and baking in a popular local bakery. Twenty-five episodes from each show were viewed. Coding involved tallying how many times 17 FDA Food Code recommendations were or were not followed. On each show, bare hands frequently came in contact with ready-to-eat food. On a per-hour basis, this occurred 80, 155, and 176 times on shows 1-3, respectively. Hands were washed before cooking three times on the three shows and never for the recommended 20 seconds. On each show, many people touched food while wearing jewelry other than a plain wedding band, for an average of at least 7 people per hour on each show. Shows 1-3 had high rates of long-haired bakers not wearing hair restraints (11.14, 6.57, and 14.06 per hour, respectively. Shows 1 and 2 had high rates of running among the bakers (22.29 and 10.57 instances per hour, respectively. These popular baking shows do not demonstrate proper food safety techniques put forth by the FDA and do not contribute the reduction of foodborne illnesses through proper food handling.
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FDA approves efavirenz. Food and Drug Administration.
Highleyman, L
1998-10-01
The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.
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Abdulhamid, Mahmoud A.
2017-10-12
A newly designed carbocyclic pseudo Tröger\\'s base diamine (CTB) monomer, 2,8-dimethyl-3,9-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (CTBDA) and its isomeric analogue 2,8-dimethyl-(1,7)(4,10)(3,9)-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (iCTBDA), were designed for the synthesis of microporous 6FDA-based polyimides (6FDA-CTBDA and 6FDA-iCTBDA). Both polyimides were soluble, exhibited excellent thermal stability of ∼490 °C, and had high surface areas of 587 m2 g−1 (6FDA-CTBDA) and 562 m2 g−1 (6FDA-iCTBDA). A 6FDA-based polyimide derived from 4,10-dimethyl-3,9-diamino-6H,12H-5,11-methanodibenzo[b,f][1,5]-diazocine (6FDA-TBDA) was made for comparison to investigate the effects of the basic tertiary nitrogen functionality in the Tröger\\'s base diamine on the polymer properties relative to the carbocyclic 6FDA-CTBDA analogue. 6FDA-TBDA displayed lower gas permeabilities but moderately higher gas-pair permselectivities than 6FDA-CTBDA. The enhanced permselectivity of 6FDA-TBDA resulted exclusively from higher diffusion-based selectivity. Direct gas sorption measurements demonstrated that the basicity in the Tröger\\'s base bridge moiety enhanced the sorption capacity of CO2 only slightly and had no effect on the CO2/CH4 solubility selectivity in 6FDA-TBDA vs. 6FDA-CTBDA.
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1999-05-14
The Food and Drug Administration (FDA) is announcing the availability of a new compliance policy guide (CPG) entitled "Year 2000 (Y2K) Computer Compliance" (section 160-800). This guidance document represents the agency's current thinking on the manufacturing and distribution of domestic and imported products regulated by FDA using computer systems that may not perform properly before, or during, the transition to the year 2000 (Y2K). The text of the CPG is included in this notice. This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG, and it will be included in the next printing of the Compliance Policy Guides Manual. This CPG is intended for FDA personnel, and it is available electronically to the public.
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77 FR 51966 - Eastern Arizona Resource Advisory Committee
2012-08-28
... DEPARTMENT OF AGRICULTURE Forest Service Eastern Arizona Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Eastern Arizona Resource Advisory Committee...
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DEFF Research Database (Denmark)
Jørgensen, Poul-Erik; Eriksen, T.; Jensen, B.K.
1992-01-01
ATP content, oxygen utilization rate (OUR) and fluorescein diacetate (FDA) hydrolysis were tested for the ability to express the amount of viable biomass in wastewater and activated sludge. The relationship between biomass and these activity parameters was established in growth cultures made...... with biomass, while FDA hydrolysis in the sludge failed to show any such correlation. Conversion factors of 3 mg ATP/g dw, 300 mg O2/h g dw and 0.4 A/h (mg dw/ml) for ATP, OUR and FDA methods, respectively, were calculated. When the methods were applied for in situ determinations in four different wastewater...... plants, it was found that ATP content and respiration rate estimated viable biomass to range from 81 to 293 mg dw/g SS for raw wastewater and from 67 to 187 mg dw/g SS for activated sludge with a rather weak correlation between ATP and respiration measurements. The FDA hydrolysis estimated viable biomass...
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Nields, Morgan W
2010-05-01
Digital mammography is routinely used in the US to screen asymptomatic women for breast cancer and currently over 50% of US screening centers employ the technology. In spite of FDAs knowledge that digital mammography requires less radiation than film mammography and that its equivalence has been proven in a prospective randomized trial, the agency has failed to allow the technology market access via the 510(k) pre market clearance pathway. As a result of the restrictive Pre Market Approval process, only four suppliers have received FDA approval. The resulting lack of a competitive market has kept costs high, restricted technological innovation, and impeded product improvements as a result of PMA requirements. Meanwhile, at least twelve companies are on the market in the EU and the resulting competitive market has lowered costs and provided increased technological choice. A cultural change with new leadership occurred in the early 90's at FDA. The historical culture at the Center for Devices and Radiological Health of collaboration and education gave way to one characterized by a lack of reliance on outside scientific expertise, tolerance of decision making by unqualified reviewers, and an emphasis on enforcement and punishment. Digital mammography fell victim to this cultural change and as a result major innovations like breast CT and computer aided detection technologies are also withheld from the market. The medical device law, currently under review by the Institute of Medicine, should be amended by the Congress so that new technologies can be appropriately classified in accordance with the risk based assessment classification system detailed in Chapter V of the Federal Food, Drug, and Cosmetic Act. A panel of scientific experts chartered by the NIH or IOM should determine the classification appropriate for new technologies that have no historical regulatory framework. This would be binding on FDA. Unless the law is changed we will likely again experience
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FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR Staging
An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing. Br
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39 CFR 10.2 - Advisory service.
2010-07-01
... 39 Postal Service 1 2010-07-01 2010-07-01 false Advisory service. 10.2 Section 10.2 Postal Service UNITED STATES POSTAL SERVICE THE BOARD OF GOVERNORS OF THE U.S. POSTAL SERVICE RULES OF CONDUCT FOR POSTAL SERVICE GOVERNORS (ARTICLE X) § 10.2 Advisory service. (a) The General Counsel is the Ethical...
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The FDA's decision-making process: isn't it time to temper the principle of protective paternalism?
Brandt, Lawrence J
2008-05-01
The authors conducted a well-designed, multinational, large study of women younger than 65 yr of age with irritable bowel syndrome (IBS) with a mixed pattern of diarrhea and constipation (IBS-M) or constipation (IBS-C) and showed that a statistically greater percentage of patients in each group responded to tegaserod compared with patients treated with placebo. Practicality looms large, however, in that the Food and Drug Administration (FDA) disallowed the continued marketing of tegaserod because of cardiovascular safety concerns, and it now is only available under a restricted access program. The wisdom of this decision aside, it is disturbing that the FDA revealed a zero-tolerance for any significant risk of disease when a drug (e.g., tegaserod) was used for a nonlife-threatening condition; the FDA chose to neglect any potential benefit of significant improvement in quality of life, while at the same time allowing the continued availability of sildenifil for erectile dysfunction and other medications (e.g., rosiglitazone and nonsteroidal anti-inflammatory drugs [NSAIDs]), each with a far greater risk of cardiovascular complications. Whether tegaserod will be re-released and, if so, under what conditions, is yet to be determined, as is the question of whether the FDA will decide to allow a more transparent decision-making process with input from all interested parties affected by their decision.
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42 CFR 411.386 - CMS's advisory opinions as exclusive.
2010-10-01
... 42 Public Health 2 2010-10-01 2010-10-01 false CMS's advisory opinions as exclusive. 411.386... Relationships Between Physicians and Entities Furnishing Designated Health Services § 411.386 CMS's advisory... described in § 411.370. CMS has not and does not issue a binding advisory opinion on the subject matter in...
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10 CFR 1.18 - Advisory Committee on Nuclear Waste.
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Advisory Committee on Nuclear Waste. 1.18 Section 1.18... Panels, Boards, and Committees § 1.18 Advisory Committee on Nuclear Waste. The Advisory Committee on Nuclear Waste (ACNW) provides advice to the Commission on all aspects of nuclear waste management, as...
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76 FR 57981 - Environmental Management Site-Specific Advisory Board, Portsmouth
2011-09-19
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... environmental restoration, waste management and related activities. Tentative Agenda Call to Order...
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77 FR 2283 - Environmental Management Site-Specific Advisory Board, Portsmouth
2012-01-17
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... environmental restoration, waste management and related activities. Tentative Agenda Call to Order...
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76 FR 36100 - Environmental Management Site-Specific Advisory Board, Portsmouth
2011-06-21
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... environmental restoration, waste management and related activities. Tentative Agenda Call to Order...
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77 FR 29997 - Environmental Management Site-Specific Advisory Board, Portsmouth
2012-05-21
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... environmental restoration, waste management and related activities. Tentative Agenda Call to Order...
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77 FR 37390 - Environmental Management Site-Specific Advisory Board, Portsmouth
2012-06-21
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... environmental restoration, waste management and related activities. Tentative Agenda: Call to Order...
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76 FR 78909 - Environmental Management Site-Specific Advisory Board, Portsmouth
2011-12-20
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... the areas of environmental restoration, waste management, and related activities. Tentative Agenda...
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77 FR 6790 - Environmental Management Site-Specific Advisory Board, Portsmouth
2012-02-09
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... environmental restoration, waste management and related activities. Tentative Agenda Call to Order...
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75 FR 51026 - Environmental Management Site-Specific Advisory Board, Portsmouth
2010-08-18
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... the areas of environmental restoration, waste management and related activities. Tentative Agenda...
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75 FR 51026 - Environmental Management Advisory Board
2010-08-18
... DEPARTMENT OF ENERGY Environmental Management Advisory Board AGENCY: Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Environmental Management Advisory... EMAB is to provide the Assistant Secretary for Environmental Management (EM) with advice and...
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75 FR 59747 - NASA Advisory Council; Meeting.
2010-09-28
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-113)] NASA Advisory Council; Meeting. AGENCY: National Aeronautics and Space Administration. ACTION: Notice of meeting. SUMMARY: In accordance... Space Administration announces a meeting of the NASA Advisory Council. DATES: Wednesday, October 6, 2010...
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Patients' and healthcare workers' perceptions of a patient safety advisory.
Schwappach, David L B; Frank, Olga; Koppenberg, Joachim; Müller, Beat; Wasserfallen, Jean-Blaise
2011-12-01
To assess patients' and healthcare workers' (hcw) attitudes and experiences with a patient safety advisory, to investigate predictors for patients' safety-related behaviors and determinants for staff support for the advisory. Cross-sectional surveys of patients (n= 1053) and hcw (n= 275). Three Swiss hospitals. Patients who received the safety advisory and hcw caring for these patients. Patient safety advisory disseminated to patients at the study hospitals. Attitudes towards and experiences with the advisory. Hcw support for the intervention and patients' intentions to apply the recommendations were modelled using regression analyses. Patients (95%) and hcw (78%) agreed that hospitals should educate patients how to prevent errors. Hcw and patients' evaluations of the safety advisory were positive and followed a similar pattern. Patients' intentions to engage in safety were significantly predicted by behavioral control, subjective norms, attitudes, safety behaviors during hospitalization and experiences with taking action. Hcw support for the campaign was predicted by rating of the advisory (Odds ratio (OR) 3.4, confidence interval (CI) 1.8-6.1, Ppatients (OR 1.9, CI 1.1-3.3, P= 0.034) and experience of unpleasant situations (OR 0.6, CI 0.4-1.0, P= 0.035). The safety advisory was well accepted by patients and hcw. To be successful, the advisory should be accompanied by measures that target norms and barriers in patients, and support staff in dealing with difficult situations.
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75 FR 7577 - Environmental Management Site-Specific Advisory Board, Portsmouth
2010-02-22
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... areas of environmental restoration, waste management and related activities. Tentative Agenda: Call to...
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75 FR 65615 - Environmental Management Site-Specific Advisory Board, Portsmouth
2010-10-26
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... areas of environmental restoration, waste management and related activities. Tentative Agenda Call to...
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76 FR 17118 - Environmental Management Site-Specific Advisory Board Chairs
2011-03-28
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board Chairs AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB) Chairs. The Federal Advisory Committee Act (Pub... areas of environmental restoration, waste management, and related activities. Tentative Agenda Topics...
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76 FR 62054 - Environmental Management Site-Specific Advisory Board Chairs
2011-10-06
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board Chairs AGENCY... of the Environmental Management Site-Specific Advisory Board (EM SSAB) Chairs. The Federal Advisory... environmental restoration, waste management, and related activities. Tentative Agenda Topics [cir] EM Program...
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75 FR 82003 - Environmental Management Site-Specific Advisory Board, Portsmouth
2010-12-29
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... areas of environmental restoration, waste management and related activities. Tentative Agenda: Call to...
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75 FR 19379 - Environmental Management Site-Specific Advisory Board, Portsmouth
2010-04-14
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Portsmouth AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act... areas of environmental restoration, waste management and related activities. Tentative Agenda Call to...
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77 FR 51789 - Environmental Management Site-Specific Advisory Board, Paducah
2012-08-27
... management and related activities. Tentative Agenda Call to Order, Introductions, Review of Agenda... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act...
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Mentorship through advisory colleges.
Murr, Andrew H; Miller, Carol; Papadakis, Maxine
2002-11-01
Medical students face pressures ranging from the need to create a social network to learning vast amounts of scientific material. Students often feel isolated in this system and lack mentorship. In order to counteract feelings of bureaucratic anonymity and isolation, the University of California San Francisco has created an advisory college to foster the professional and personal growth and well being of students. UCSF has developed a formal structure to advise medical students. A selection committee, chaired by the associate dean of student affairs, appointed five faculty mentors to head advisory colleges. These five colleges serve as the advising and well-being infrastructure for the students. Mentors were chosen from a balanced range of clinical disciplines, both primary and specialty. The disciplines are obstetrics-gynecology, otolaryngology/head and neck surgery, medicine, pediatrics, and psychiatry. The mentors have demonstrated excellence in advising and counseling of students. Mentors meet individually at the beginning of the academic year with incoming first-year and second-year students. They then have bimonthly meetings with eight to ten students within each college throughout the academic year. Curricula for these group sessions include well-being discussions and coping techniques, sessions on the hidden and informal curriculum of professionalism, and discussions on career choices and strategies. For third-year students, advisory college meetings are scheduled during intersessions, which are weeklong courses that occur between the eight-week clerkship blocks. Mentors are available throughout the year to meet with students on an as-needed basis, and advisory colleges may hold group social activities. The dean's office supports each mentor with 20% salary and provides administrative support for the group college activities. Historically, UCSF students feel they receive an excellent education and appropriate job opportunities, but they do not feel they
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75 FR 6018 - Environmental Management Site-Specific Advisory Board, Hanford
2010-02-05
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Hanford AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Hanford (known locally as the Hanford Advisory... and site management in the areas of environmental restoration, waste management, and related...
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78 FR 70987 - Proxy Advisory Firm Roundtable
2013-11-27
... Firm Roundtable AGENCY: Securities and Exchange Commission. ACTION: Notice of roundtable discussion... advisory firms. The panel will be asked to discuss topics including the current state of proxy advisory firm use by investment advisers and institutional investors and potential changes that have been...
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78 FR 74174 - Humanities Panel Advisory Committee
2013-12-10
... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Humanities Panel Advisory Committee AGENCY: National Endowment for the Humanities. ACTION: Notice of Charter Renewal for Humanities Panel Advisory... its implementing regulations, 41 CFR 102-3.65, the National Endowment for the Humanities (NEH) gives...
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76 FR 67717 - Nuclear Energy Advisory Committee
2011-11-02
... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Department of Energy, Office of Nuclear Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Nuclear...: [email protected]nuclear.energy.gov . SUPPLEMENTARY INFORMATION: Background: The Nuclear Energy Advisory...
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77 FR 26274 - Nuclear Energy Advisory Committee
2012-05-03
... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Department of Energy, Office of Nuclear Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Nuclear[email protected]nuclear.energy.gov . SUPPLEMENTARY INFORMATION: Background: The Nuclear Energy Advisory Committee...
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78 FR 76599 - Nuclear Energy Advisory Committee
2013-12-18
... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Office of Nuclear Energy..., General Services Administration, notice is hereby given that the Nuclear Energy Advisory Committee (NEAC... to the Department of Energy's Office of Nuclear Energy on complex science and technical issues that...
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75 FR 67351 - Nuclear Energy Advisory Committee
2010-11-02
... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Office of Nuclear Energy, Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Nuclear... [email protected]nuclear.energy.gov . SUPPLEMENTARY INFORMATION: Background: The Nuclear Energy Advisory...
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75 FR 13269 - Nuclear Energy Advisory Committee
2010-03-19
... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Department of Energy, Office of Nuclear Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Nuclear[email protected]nuclear.energy.gov . SUPPLEMENTARY INFORMATION: Background: The Nuclear Energy Advisory Committee...
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Federal Advisory Committee Act (FACA) Database-Complete-Raw
General Services Administration — The Federal Advisory Committee Act (FACA) database is used by Federal agencies to continuously manage an average of 1,000 advisory committees government-wide. This...
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77 FR 76452 - Grain Inspection Advisory Committee Reestablishment
2012-12-28
...; Telephone (202) 205-8281; Fax (202) 690-2173; Email [email protected] . SUPPLEMENTARY INFORMATION: The... marketing of grain. The Advisory Committee serves an essential function. Information about the Advisory...
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76 FR 5147 - Environmental Management Site-Specific Advisory Board, Paducah
2011-01-28
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and...
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77 FR 59598 - Environmental Management Site-Specific Advisory Board, Paducah
2012-09-28
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and...
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75 FR 13269 - Environmental Management Site-Specific Advisory Board, Hanford
2010-03-19
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Hanford AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Hanford. The Federal Advisory Committee Act... is to make recommendations to DOE-EM and site management in the areas of environmental restoration...
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75 FR 54600 - Environmental Management Site-Specific Advisory Board, Paducah
2010-09-08
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and...
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75 FR 66074 - Environmental Management Site-Specific Advisory Board, Paducah
2010-10-27
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and...
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75 FR 8050 - Environmental Management Site-Specific Advisory Board, Hanford
2010-02-23
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Hanford AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Hanford. The Federal Advisory Committee Act... is to make recommendations to DOE-EM and site management in the areas of environmental restoration...
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75 FR 24686 - Environmental Management Site-Specific Advisory Board, Paducah
2010-05-05
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and...
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76 FR 80355 - Environmental Management Site-Specific Advisory Board, Paducah
2011-12-23
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... make recommendations to DOE-EM and site management in the areas of environmental restoration, waste...
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75 FR 9404 - Environmental Management Site-Specific Advisory Board, Paducah
2010-03-02
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and...
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77 FR 43583 - Environmental Management Site-Specific Advisory Board, Paducah
2012-07-25
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and...
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75 FR 61711 - Environmental Management Site-Specific Advisory Board, Paducah
2010-10-06
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and...
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75 FR 82002 - Environmental Management Site-Specific Advisory Board, Paducah
2010-12-29
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and...
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76 FR 61350 - Environmental Management Site-Specific Advisory Board, Paducah
2011-10-04
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... make recommendations to DOE-EM and site management in the areas of environmental restoration, waste...
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76 FR 4645 - Environmental Management Site-Specific Advisory Board, Hanford
2011-01-26
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Hanford AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Hanford. The Federal Advisory Committee Act... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and...
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76 FR 48148 - Environmental Management Site-Specific Advisory Board, Paducah
2011-08-08
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and...
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78 FR 4399 - National Advisory Council on Indian Education (NACIE)
2013-01-22
... DEPARTMENT OF EDUCATION National Advisory Council on Indian Education (NACIE) AGENCY: U.S... the upcoming public meeting of the National Advisory Council on Indian Education (the Council) and is... Final Agenda). SUPPLEMENTARY INFORMATION: The National Advisory Council on Indian Education is...
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76 FR 25361 - DHS Data Privacy and Integrity Advisory Committee
2011-05-04
..., Executive Director, Data Privacy and Integrity Advisory Committee, Department of Homeland Security... DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [Docket No. DHS-2011-0022] DHS Data... of Federal Advisory Committee Meeting SUMMARY: The DHS Data Privacy and Integrity Advisory Committee...
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77 FR 19740 - Biological Sciences Advisory Committee; Notice of Meeting
2012-04-02
... NATIONAL SCIENCE FOUNDATION Biological Sciences Advisory Committee; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L., 92- 463, as amended), the National Science Foundation announces the following meeting: Name: Biological Sciences Advisory Committee ( 1110). Date and...
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75 FR 30804 - Biomass Research and Development Technical Advisory Committee
2010-06-02
... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY.... SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory... public are welcome to observe the business of the Biomass Research and Development Technical Advisory...
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75 FR 11526 - Biomass Research and Development Technical Advisory Committee
2010-03-11
... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY.... SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory... public are welcome to observe the business of the Biomass Research and Development Technical Advisory...
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75 FR 74026 - Biomass Research and Development Technical Advisory Committee
2010-11-30
... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY.... SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory... participation. This notice announces the meeting of the Biomass Research and Development Technical Advisory...
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Current and future state of FDA-CMS parallel reviews.
Messner, D A; Tunis, S R
2012-03-01
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians.
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75 FR 25199 - Medbow-Routt Resource Advisory Committee
2010-05-07
... Community Self-Determination Act (Pub. L. 110- 343) and in compliance with the Federal Advisory Committee... Advisory Committee Overview; Roles and Responsibilities of RAC; Rules/ Operational Guides and Bylaws; Flow...
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Language and Nutrition (Mis)Information: Food Labels, FDA Policies and Meaning
Taylor, Christy Marie
2013-01-01
In this dissertation, I address the ways in which food manufacturers can exploit the often vague and ambiguous nature of FDA policies concerning language and images used on food labels. Employing qualitative analysis methods (Strauss, 1987; Denzin and Lincoln, 2003; Mackey and Gass, 2005) that drew upon critical discourse analysis (Fairclough,…
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21 CFR 14.15 - Committees working under a contract with FDA.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... committee: (1) The committee shall give public notice of its meetings and agenda, and provide interested...
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FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR
The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer In
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The rosiglitazone decision process at FDA and EMA : What should we learn?
Pouwels, Koen B.; van Grootheest, Kees
2012-01-01
In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased
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75 FR 65310 - Environmental Management Site-Specific Advisory Board, Nevada
2010-10-22
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Nevada AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada Test Site. The Federal Advisory... Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration...
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75 FR 82004 - Environmental Management Site-Specific Advisory Board, Nevada
2010-12-29
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Nevada AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act (Pub... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and...
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77 FR 4027 - Environmental Management Site-Specific Advisory Board, Nevada
2012-01-26
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Nevada AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act (Pub... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and...
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76 FR 80354 - Environmental Management Site-Specific Advisory Board, Nevada
2011-12-23
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Nevada AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act (Pub... recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and...
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77 FR 12044 - Environmental Management Site-Specific Advisory Board, Nevada
2012-02-28
... DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Nevada AGENCY... Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act (Pub... Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration...
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78 FR 64932 - Biomass Research and Development Technical Advisory Committee
2013-10-30
... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY: Energy... announces an open meeting of the Biomass Research and Development Technical Advisory Committee under Section... Biomass Research and Development Technical Advisory Committee. To attend the meeting and/or to make oral...
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75 FR 56525 - Biomass Research and Development Technical Advisory Committee
2010-09-16
... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY.... SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory... business of the Biomass Research and Development Technical Advisory Committee. To attend the meeting and/or...
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77 FR 64970 - Biomass Research and Development Technical Advisory Committee
2012-10-24
... Biomass Research and Development Technical Advisory Committee. The Federal Advisory Committee Act (Pub. L... observe the business of the Biomass Research and Development Technical Advisory Committee. To attend the... DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Biomass Research and...
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78 FR 29125 - Biomass Research and Development Technical Advisory Committee
2013-05-17
... Biomass Research and Development Technical Advisory Committee. The Federal Advisory Committee Act (Pub. L... public are welcome to observe the business of the Biomass Research and Development Technical Advisory... DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Biomass Research and...
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77 FR 75695 - Overseas Schools Advisory Council; Notice of Meeting
2012-12-21
... DEPARTMENT OF STATE [Public Notice 8130] Overseas Schools Advisory Council; Notice of Meeting The Overseas Schools Advisory Council, Department of State, will hold its Executive Committee Meeting on.... The Overseas Schools Advisory Council works closely with the U.S. business community in improving...
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76 FR 78079 - Overseas Schools Advisory Council Notice of Meeting
2011-12-15
... DEPARTMENT OF STATE [Public Notice 7712] Overseas Schools Advisory Council Notice of Meeting The Overseas Schools Advisory Council, Department of State, will hold its Executive Committee Meeting on.... The Overseas Schools Advisory Council works closely with the U.S. business community in improving...
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78 FR 77195 - Overseas Schools Advisory Council; Notice of Meeting
2013-12-20
... DEPARTMENT OF STATE [Public Notice 8564] Overseas Schools Advisory Council; Notice of Meeting The Overseas Schools Advisory Council, Department of State, will hold its Executive Committee Meeting on.... The Overseas Schools Advisory Council works closely with the U.S. business community in improving...
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Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014
Directory of Open Access Journals (Sweden)
Benjamin Hixon
2017-02-01
Full Text Available Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC. The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9% of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%. The three most frequently reported labeling changes were warnings (68.7%, precautions (58.6%, and patient package insert/medication guide (23.2%. Case reports resulted in the greatest number of documented literature types (n = 791, followed by randomized controlled trials (n = 76, and case control/cohort studies (n = 74. Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%, compared to LOE A (17.1%, and LOE C (14.1% (p = 0.007. Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties. Type: Original Research
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75 FR 9886 - Methane Hydrate Advisory Committee
2010-03-04
... DEPARTMENT OF ENERGY Methane Hydrate Advisory Committee AGENCY: Department of Energy, Office of Fossil Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Methane... the Committee: The purpose of the Methane Hydrate Advisory Committee is to provide advice on potential...
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78 FR 41804 - NASA Advisory Council; Meeting.
2013-07-11
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (13-077)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council (NAC). DATES: Wednesday, July 31... ADDRESSES: NASA Headquarters, Room 9H40, Program Review Center, 300 E Street SW., Washington, DC 20456 FOR...
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78 FR 70932 - Nuclear Energy Advisory Committee
2013-11-27
... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Office of Nuclear Energy, Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Nuclear[email protected]nuclear.energy.gov . SUPPLEMENTARY INFORMATION: Background: The Nuclear Energy Advisory Committee (NEAC...
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44 CFR 208.35 - Reimbursement for Advisory.
2010-10-01
... Cooperative Agreements § 208.35 Reimbursement for Advisory. DHS will not reimburse costs incurred during an... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Reimbursement for Advisory. 208.35 Section 208.35 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY...
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Advisory Boards: Gateway to Business Engagement
Meeder, Hans; Pawlowski, Brett
2012-01-01
Interest has been growing in how to build or manage an effective business advisory board. Developing an advisory board is crucial to keeping CTE programs relevant and viable by engaging the support of business and industry. This article delves into how to build and manage a board, and how to re-energize boards that already exist but may be lacking.