The FDA Struggle to Withdraw Makena-Reference-Cited by-同舟云学术

The FDA Struggle to Withdraw Makena

Published:2022-12-27 Issue:24 Volume:328 Page:2394
ISSN:0098-7484
Container-title:JAMA
language:en
Short-container-title:JAMA

Author:

Aaron Daniel G.¹²,Cohen I. Glenn³,Adashi Eli Y.⁴

Affiliation:

1. Harvard Law School, Cambridge, Massachusetts

2. US Court of Appeals for the Sixth Circuit, Louisville, Kentucky

3. Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts

4. Department of Medical Science, Brown University, Providence, Rhode Island

Abstract

This Viewpoint discusses the controversy surrounding the FDA’s efforts to withdraw Makena from the market and the broader implications for the accelerated approval pathway.

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jama/articlepdf/2799570/jama_aaron_2022_vp_220140_1671488973.40223.pdf

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5. Kammerman? LA. Application number 21945Orig1s000: statistical reviews. FDA Center for Drug Evaluation and Research. July 13, 2010. Accessed November 30, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021945Orig1s000StatR.pdf

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