학술논문
Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway.
Document Type
Article
Author
Source
Subject
*DRUG approval
Language
ISSN
0098-7484
Abstract
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. [ABSTRACT FROM AUTHOR]