Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway
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Media type:
E-Article
Title:
Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway
Contributor:
Shahzad, Mahnum;
Naci, Huseyin;
Wagner, Anita K.
imprint:
American Medical Association (AMA), 2023
Published in:JAMA
Language:
English
DOI:
10.1001/jama.2023.0625
ISSN:
0098-7484
Origination:
Footnote:
Description:
<jats:p>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.</jats:p>