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

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

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.

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Bibliographische Detailangaben
Veröffentlicht in:JAMA : the journal of the American Medical Association 2023-03, Vol.329 (9), p.760-761
Hauptverfasser: Shahzad, Mahnum, Naci, Huseyin, Wagner, Anita K
Format: Artikel
Sprache:eng
Schlagworte:
Clinical trials
Conversion
Drug Approval - methods
Letter
Letters
Online First
Reforming
Research Letter
United States
United States Food and Drug Administration
Online-Zugang:Volltext
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Beschreibung
Zusammenfassung: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.
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.2023.0625