Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015-Reference-Cited by-同舟云学术

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Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015

Published:2020-07-24 Issue:7 Volume:3 Page:e209498
ISSN:2574-3805
Container-title:JAMA Network Open
language:en
Short-container-title:JAMA Netw Open

Author:

MacGregor Andrea¹,Zhang Audrey D.²,Wallach Joshua D.³,Ross Joseph S.⁴,Herder Matthew⁵⁶

Affiliation:

1. Schulich School of Law, Dalhousie University, Halifax, Nova Scotia, Canada

2. New York University School of Medicine, New York, New York

3. Department of Environmental Health Sciences, Yale School of Public Health, New Haven, Connecticut

4. Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut

5. Health Law Institute, Schulich School of Law, Dalhousie University, Halifax, Nova Scotia, Canada

6. Department of Pharmacology, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2768613/macgregor_2020_ld_200058.pdf

Reference6 articles.

1. Approving a problematic muscular dystrophy drug: implications for FDA policy.;Kesselheim;JAMA,2016

2. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.;Downing;JAMA,2014

3. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.;Wallach;BMJ,2018

4. Integrated drug reviews at the US Food and Drug Administration: legal concerns and knowledge lost.;Herder;JAMA Intern Med,2020

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1. US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics;BMJ Evidence-Based Medicine;2023-03-21

2. The Prescription Drug User Fee Act;Medical Care;2022-02-10

3. U.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013–2018;Annals of Internal Medicine;2021-11

4. Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?;Clinical Therapeutics;2021-05

5. Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19;International Journal of Health Services;2020-12-21

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