NDA/PLA CLASS OF FY 1995 WILL ACHIEVE APPROVAL RATE OF APPROXIMATELY 80% -- USER FEE REPORT; CBER PILOTING "COMPLETE REVIEW" LETTERS TO REPLACE "APPROVABLE"
Executive Summary
FDA expects that about 80% of the 118 NDAs and PLAs submitted in fiscal 1995 will ultimately be approved, the agency estimates in a user fee performance report forwarded to Congress on Dec. 6.