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

Mahnum Shahzad; Huseyin Naci; Anita K Wagner

doi:10.1001/jama.2023.0625

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.

Authors

Mahnum Shahzad¹, Huseyin Naci², Anita K Wagner¹

Affiliations

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.

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*