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# GDUFA Post-Warning Letter Meeting Guidance
- URL: https://www.fdaweb.com/gdufa-post-warning-letter-meeting-guidance/
- Published: 2025-06-18T12:00:00.000Z
- Updated: 2026-09-14T15:14:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159381

FDA has published a guidance, *Post-Warning Letter Meetings Under GDUFA*, with information on the implementation of the post-Warning Letter meeting process for certain facilities as covered in the GDUFA 3 commitment letter. The [document](https://www.fda.gov/media/171785/download?ref=fdaweb.com) says a post-Warning Letter meeting is a meeting with FDA about the facility’s remediation of deficiencies identified in a Warning Letter.

The guidance describes the process in the commitment letter for how an eligible facility may request a post-Warning Letter meeting with FDA about the facility’s ongoing remediation efforts to address CGMP deficiencies described in a Warning Letter, how to prepare and submit a complete meeting request package, and how FDA intends to conduct the meeting.

The guidance includes an Introduction, Background, GDUFA performance goals, Post-Warning Letter Meetings, Eligibility Criteria, Meeting Requests for Post-Warning Letter Meetings, Assessing Meeting Requests, Rescheduling and Canceling Post-Warning Letter Meetings, and Procedures for Conduct of Meetings.