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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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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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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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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Post-SARS-CoV-2 monoclonal antibody treatment hospitalizations as a sentinel for emergence of viral variants in New York City

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab313 ◽

2021 ◽

Author(s):

Kelsie Cowman ◽

Yi Guo ◽

Liise-anne Pirofski ◽

David Wong ◽

Hongkai Bao ◽

...

Keyword(s):

New York ◽

Monoclonal Antibody ◽

New York City ◽

York City ◽

Human Services ◽

Antibody Treatment ◽

Health And Human Services ◽

Department Of Health ◽

Monoclonal Antibody Treatment ◽

Abstract We partnered with the U.S. Department of Health and Human Services to treat high-risk, non-admitted COVID-19 patients with bamlanivimab in the Bronx, NY per Emergency Use Authorization criteria. Increasing post-treatment hospitalizations were observed monthly between December 2020-March 2021 in parallel to the emergence of SARS-CoV-2 variants in New York City.

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