Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway-Reference-Cited by-同舟云学术

Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway

Published:2023-03-07 Issue:9 Volume:329 Page:760
ISSN:0098-7484
Container-title:JAMA
language:en
Short-container-title:JAMA

Author:

Shahzad Mahnum¹,Naci Huseyin²,Wagner Anita K.¹

Affiliation:

1. Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, Massachusetts

2. Department of Health Policy, London School of Economics and Political Science, London, United Kingdom

Abstract

This study examines the Food and Drug Administration’s accelerated approval pathway and whether preapproval initiation was associated with faster conversion to traditional approval or withdrawal for drugs with nononcology indications.

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jama/articlepdf/2801050/jama_shahzad_2023_ld_230007_1677717783.54762.pdf

Reference6 articles.

1. The on- and off-ramps of oncology accelerated approval.;Fashoyin-Aje;N Engl J Med,2022

2. Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration.;Naci;JAMA,2017

3. Pharmaceutical drugs of uncertain value, lifecycle regulation at the US Food and Drug Administration, and institutional incumbency.;Herder;Milbank Q,2019

4. Assessment of the clinical benefit of cancer drugs receiving accelerated approval.;Gyawali;JAMA Intern Med,2019

5. US Department of Health and Human Services Office of Inspector General. Delays in confirmatory trials for drug applications granted FDA’s accelerated approval raise concerns. September 2022. Accessed October 11, 2022. https://oig.hhs.gov/oei/reports/OEI-01-21-00401.pdf

Cited by 13 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Financial Toxicity of Withdrawn Poly (Adenosine Diphosphate Ribose) Polymerase Inhibitor Indications for Ovarian Cancer;Value in Health;2024-09

2. Analysis of post-marketing requirements for oncology drug conditional approvals in the United States and China;Heliyon;2024-08

3. Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals;Clinical and Translational Science;2024-07

4. Evaluating time to withdrawal of anti-cancer drug indications that received FDA’s accelerated approval;QJM: An International Journal of Medicine;2024-06-12

5. Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway;Journal of Pharmaceutical Policy and Practice;2024-06-04