SPONSOR PERFORMANCE UNDER USER FEES: 77% OF NDAs SUBMITTED WITHOUT MAJOR AMENDMENT IN FY 1994, FDA TELLS CONGRESS; NO BACKLOG EXPECTED BY EARLY 1995
Executive Summary
Decreases in the number of NDA submissions requiring major and minor amendments reflect sponsors' greater attention to filing complete applications, FDA asserts in the agency's "Fiscal Year 1994 Report to Congress" on user fees.