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

JAMA. 2023 Mar 7;329(9):760-761. doi: 10.1001/jama.2023.0625.
No abstract available

Plain language summary

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.

MeSH terms

  • Drug Approval* / methods
  • United States
  • United States Food and Drug Administration*