U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine: Guidance for Industry: Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products (VICH GL40)

Biotechnology Law Report ◽

10.1089/blr.2006.25.447 ◽

2006 ◽

Vol 25 (4) ◽

pp. 447-460

Keyword(s):

Veterinary Medicine ◽

Drug Administration ◽

Human Services ◽

Food And Drug Administration ◽

Medicinal Products ◽

Test Procedures ◽

Acceptance Criteria ◽

Health And Human Services ◽

Department Of Health ◽

Veterinary Medicinal Products

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Department of Health and Human Services, U.S. Food and Drug Administration: Authority and Responsibility

FDA Administrative Enforcement Manual ◽

10.1201/9781420037838-6 ◽

2005 ◽

pp. 21-60

Keyword(s):

Drug Administration ◽

Human Services ◽

Food And Drug Administration ◽

Health And Human Services ◽

Department Of Health

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American Epilepsy Society (AES): Written Comments to Norman E. “Ned” Sharpless, MD, Acting Commissioner of Food and Drugs, U.S. Food and Drug Administration (FDA), Department of Health and Human Services (HHS)

Epilepsy Currents ◽

10.1177/1535759719878716 ◽

2019 ◽

Vol 19 (6) ◽

pp. 361-368 ◽

Author(s):

Timothy E. Welty ◽

Kevin E. Chapman ◽

R. Edward Faught ◽

Robert J. Kotloski

Keyword(s):

Drug Administration ◽

Human Services ◽

Food And Drug Administration ◽

Health And Human Services ◽

Department Of Health ◽

Written Comments

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The Process of Regulatory Review for New Cardiovascular Devices * *This chapter represents the professional opinions of the authors and is not an official document, agency guidance, or policy of the U.S. Government, the Department of Health and Human Services, or the Food and Drug Administration, nor should any official endorsement be inferred.

Cardiovascular Therapeutics ◽

10.1016/b978-1-4160-3358-5.50010-3 ◽

2007 ◽

pp. 67-75

Author(s):

Neal I. Muni ◽

Bram D. Zuckerman

Keyword(s):

Drug Administration ◽

Human Services ◽

Food And Drug Administration ◽

Regulatory Review ◽

Official Document ◽

Cardiovascular Devices ◽

Health And Human Services ◽

Department Of Health ◽

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Epigenetics in Reproduction and Development ∗ ∗The opinions expressed in this article are the authors' personal opinions and do not necessarily reflect those of US Food and Drug Administration, Department of Health and Human Services, or the Federal Government.

Reproductive and Developmental Toxicology ◽

10.1016/b978-0-12-804239-7.00052-4 ◽

2017 ◽

pp. 1005-1021

Author(s):

Kotaro Kaneko ◽

Supratim Choudhuri

Keyword(s):

Federal Government ◽

Drug Administration ◽

Human Services ◽

Food And Drug Administration ◽

Health And Human Services ◽

Department Of Health

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Allowable limits for toxic leachables: practical use of ISO 10993-17 standard * *The recommendations offered in this chapter should not be construed as guidance from the US Food and Drug Administration (FDA). The mention of commercial products, their sources or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services.

Biocompatibility and Performance of Medical Devices ◽

10.1533/9780857096456.2.95 ◽

2012 ◽

pp. 95-119 ◽

Author(s):

R.P. Brown

Keyword(s):

Drug Administration ◽

Human Services ◽

Food And Drug Administration ◽

Commercial Products ◽

Health And Human Services ◽

Department Of Health ◽

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Statement by Janet Woodcock, M.D., Director, Center For Drug Evaluation and Research, U.S. Food and Drug Administration, Department of Health and Human Services, before the Senate Special Committee on Aging, July 22, 2003

PsycEXTRA Dataset ◽

10.1037/e309442004-001 ◽

2003 ◽

Author(s):

Janet Woodcock

Keyword(s):

Drug Administration ◽

Human Services ◽

Drug Evaluation ◽

Food And Drug Administration ◽

Special Committee ◽

Health And Human Services ◽

Department Of Health

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Guidance for Industry by U.S. Department of Health and Human Services—Food and Drug Administration—Center for Biologics Evaluation and Research (CBER)—February 1999

Biotechnology ◽

10.1201/9781420084498-32 ◽

2009 ◽

pp. 657-721 ◽

Keyword(s):

Drug Administration ◽

Human Services ◽

Food And Drug Administration ◽

Health And Human Services ◽

Department Of Health

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Department of Health and Human Services, U.S. Food and Drug Administration

FDA Administrative Enforcement Manual ◽

10.1201/9781420037838.ch1 ◽

2005 ◽

pp. 1-39

Keyword(s):

Drug Administration ◽

Human Services ◽

Food And Drug Administration ◽

Health And Human Services ◽

Department Of Health

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Department of Health and Human Services, U.S. Food and Drug Administration

FDA Administrative Enforcement Manual ◽

10.1201/9780849330674.ch1 ◽

2005 ◽

pp. 1-39 ◽

Keyword(s):

Drug Administration ◽

Human Services ◽

Food And Drug Administration ◽

Health And Human Services ◽

Department Of Health

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Should the HHS Decision to Overrule FDA on Plan B Be Reversed

Journal of Commercial Biotechnology ◽

10.5912/jcb600 ◽

2013 ◽

Vol 19 (2) ◽

Author(s):

Peter J. Pitts

Keyword(s):

Drug Administration ◽

Emergency Contraception ◽

Human Services ◽

Regulatory Action ◽

Over The Counter ◽

White House ◽

Health And Human Services ◽

Department Of Health ◽

On December 7, 2011, Secretary of Health and Human Services Kathleen Sebelius overruled a decision of the Food and Drug Administration (FDA) on the over-the-counter (OTC) status of emergency contraception. What will be the repercussions of Secretary Sebeliusâ€™s action? Why is the act itself of far greater long-term significance than the transitory regulatory action it impacts? By reversing an FDA decision, the Secretary has set a dangerous precedent for all-comers to lobby Congress, the Department of Health and Human Services (HHS) and the White House on any and all FDA decisionsâ€”directly inserting politics into what must be a scientifically driven process.

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