AGDUFA: Progressively Expediting and Improving Review
AGDUFA established increasingly challenging review performance goals for FDA that are phased in over a 5-year period from FY 2009 through FY 2013. The AGDUFA performance goals lead to progressive, yearly performance improvements, with the on-time goal for review and action on submissions getting shorter each fiscal year. By the final year of AGDUFA, FDA agrees to review and act on 90 percent of the following submission types within the specified times (number of days):
- Original ANADAs and reactivations within 270 days of the submission date.
- Administrative ANADAs (ANADAs submitted after all scientific decisions have been made during the JINAD process, i.e., prior to the submission of the original ANADA) within 100 days after the submission date.
- Manufacturing supplemental ANADAs and reactivations within 270 days after the submission date.
- JINAD study submissions within 270 days after the submission date.
- JINAD protocol submissions within 100 days after submission date. JINAD protocol submissions consist of protocols without substantial data that FDA and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an ANADA or supplemental ANADA
The 5-year progression of these goals is summarized in Appendix B.