FDA’s Generic Drug Program: Decreasing Time to Approval and Number of Review Cycles

Abstract

Implementation of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act of 2012 (Generic Drug User Fee Amendments. https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments) successfully allowed the U.S. Food and Drug Administration (FDA) to modernize review of Abbreviated New Drug Applications (ANDAs) with goal dates. The goal of this study was to assess the success of GDUFA I in decreasing ANDA time to approval and the number of review cycles across the five fiscal years of GDUFA I. Results of this study underscore FDA's continuous progress within its generic drug program and highlight the ongoing collaborative communication process between FDA and ANDA applicants that must continue for the timely approval of high-quality, safe, and effective generic drugs for the American public.