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# 5 GDUFA 3 Reauthorization Meeting Summaries
- URL: https://www.fdaweb.com/5-gdufa-3-reauthorization-meeting-summaries/
- Published: 2021-05-13T12:00:00.000Z
- Updated: 2026-09-14T16:58:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149312

FDA has released its summaries from five GDUFA 3 reauthorization meetings. The summaries with discussion topics were: 

- [March 25](http://www.fda.gov/media/147613/download?ref=fdaweb.com) – Continued clarifying discussions around shared proposals related to drug master files; FDA proposals to streamline annual reporting commitments; the role of inspections in meeting the requirements for a complete review; and industry thoughts on the FDA resources needed proposal.
- [April 1](http://www.fda.gov/media/148046/download?ref=fdaweb.com) – Continued discussions of the implementation of the Inactive Ingredient Database; the role of inspections in meeting the requirements for a complete review; streamlining annual reporting commitments; FDA proposals intended to set a sound foundation for continued programmatic success.
- [April 8](http://www.fda.gov/media/148096/download?ref=fdaweb.com) – Drug master files and streamlining annual report commitments; drafting of the GDUFA 3 commitment letter; FDA clarifying information on how a capacity planning adjuster could work in GDUFA 3.
- [April 15](http://www.fda.gov/media/148547/download?ref=fdaweb.com) – Continued discussion on FDA proposals intended to set a sound foundation for continued programmatic success; drug master files; criteria for a complete response when an inspection is not feasible due to a public health emergency or travel restrictions; streamlining reporting requirements; and new industry proposals on process improvements to increase earlier approvals of complex products.
- [April 22](http://www.fda.gov/media/148548/download?ref=fdaweb.com) – FDA clarification of proposals for setting a sound foundation for maintaining programmatic success and inspections and streamlining annual reporting requirements; industry and FDA agreed not to move forward with the Site Engagement Program; discussion of the Inactive Ingredient Database.