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

This study examines the Food and Drug Administration’s accelerated approval pathway and whether preapproval initiation was associated with faster conversion to

Related Keywords

Boston ,Massachusetts ,United States ,United Kingdom ,American ,Jodyw Zylke ,Mahnum Shahzad ,Kristin Walter ,Harvard Pilgrim Health Care Institute ,United Kingdom Research ,Drug Administration ,Harvard Medical School ,Health Foundation ,Group Of The European Union ,National Institute For Health ,Harvard Pilgrim Health Care Institutional Review Board ,Care Research ,American Cancer Society ,Deputy Editor ,Interest Disclosures ,National Institute ,Pharmaceutical Group ,European Union ,American Cancer ,