Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018-Reference-Cited by-同舟云学术

Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018

Published:2021-11-09 Issue:11 Volume:4 Page:e2133601
ISSN:2574-3805
Container-title:JAMA Network Open
language:en
Short-container-title:JAMA Netw Open

Author:

Wallach Joshua D.¹,Ramachandran Reshma²³,Bruckner Till⁴⁵,Ross Joseph S.²⁶

Affiliation:

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

2. National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut

3. Department of Internal Medicine, Veterans Affairs Connecticut Healthcare System and Yale University, West Haven, Connecticut

4. QUEST Center, Berlin Institute of Health, Charité, Universitätsmedizin Berlin, Berlin, Germany

5. TranspariMED, Bristol, United Kingdom

6. Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2785883/wallach_2021_ld_210242_1635436984.36678.pdf

Reference6 articles.

1. A 25-year experience of US Food and Drug Administration accelerated approval of malignant hematology and oncology drugs and biologics: a review.;Beaver;JAMA Oncol,2018

2. Fulfilling the mandate of the US Food and Drug Administration’s accelerated approval pathway: the need for reforms.;Gyawali;JAMA Intern Med,2021

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

4. 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

5. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.;Skydel;Clin Trials,2021

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