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

View Abstract
Abbreviation
JAMA
Publication Date
2023-01-27
Pubmed ID
36705931
Medium
Print-Electronic
Full Title
Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway.
Authors
Shahzad M, Naci H, Wagner AK