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.

Automated summary

This study investigates the relationship between the FDA's accelerated approval pathway and the speed of conversion to traditional approval or withdrawal for drugs without oncology indications.