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# Product-Specific Guidance Meetings
- URL: https://www.fdaweb.com/product-specific-guidance-meetings/
- Published: 2023-02-17T12:00:00.000Z
- Updated: 2026-09-14T18:16:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153811

FDA has published a draft guidance, *Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA*, with information on requesting and conducting product-specific guidance (PSG) meetings with FDA as contemplated in the GDUFA 3 reauthorization commitment letter. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-specific-guidance-meetings-between-fda-and-anda-applicants-under-gdufa?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the guidance is intended to provide procedures that will promote well-managed PSG meetings and help ensure that such meetings are scheduled and conducted following the time frames in the commitment letter.

The contents of the guidance are Introduction, Background, Meeting Types, GDUFA 3 Performance Goals, Meeting Requests, Evaluating Meeting Requests, Rescheduling and Canceling Meetings, Meeting Package Content, Pre-Meeting Communications with Applicants, Procedures for Conduct of Meetings, Documentation and Meeting Minutes, and Resolution of Dispute About Meeting Minutes.