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

Andrea MacGregor; Audrey D Zhang; Joshua D Wallach; Joseph S Ross; Matthew Herder

doi:10.1001/jamanetworkopen.2020.9498

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

JAMA Netw Open. 2020 Jul 1;3(7):e209498. doi: 10.1001/jamanetworkopen.2020.9498.

Authors

Andrea MacGregor¹, Audrey D Zhang², Joshua D Wallach³, Joseph S Ross⁴, Matthew Herder^{5

6}

Affiliations

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.

Abstract

This cross-sectional study examines the frequency of disagreements within the US Food and Drug Administration (FDA) regarding approval of novel therapeutic agents.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Cross-Sectional Studies
Drug Approval / legislation & jurisprudence
Drug Approval / statistics & numerical data*
Drugs, Investigational / therapeutic use
Legislation, Drug / standards*
Pharmaceutical Preparations / standards*
Product Surveillance, Postmarketing / statistics & numerical data*
Registries / statistics & numerical data
United States
United States Food and Drug Administration / standards*

Substances

Drugs, Investigational
Pharmaceutical Preparations

Abstract

Publication types

MeSH terms

Substances

Grants and funding