Postmarketing Safety‐Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002–2014: Similarities and Differences With New Molecular Entities-Reference-Cited by-同舟云学术

Postmarketing Safety‐Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002–2014: Similarities and Differences With New Molecular Entities

Published:2020-09-08 Issue:6 Volume:108 Page:1243-1253
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Bulatao Ilynn¹,Pinnow Ellen¹,Day Brendan²,Cherkaoui Sanae¹,Kalaria Manish¹,Brajovic Sonja¹,Dal Pan Gerald¹

Affiliation:

1. Office of Surveillance and Epidemiology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. School of Medicine University of Maryland Baltimore Maryland USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1948

Reference21 articles.

1. FDA.Therapeutic Biologics Applications (BLA) (2020). Accessed 14 August 2020.

2. Additional safety risk to exceptionally approved drugs in Europe?

3. Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates

4. The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety

5. Drug-Review Deadlines and Safety Problems

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