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# Generic Post-Warning Letter Meetings Guide
- URL: https://www.fdaweb.com/generic-post-warning-letter-meetings-guide/
- Published: 2023-09-01T12:00:00.000Z
- Updated: 2026-09-14T18:54:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155234

FDA has released a [draft guidance](https://www.fda.gov/media/171785/download?ref=fdaweb.com) entitled “Post-Warning Letter Meetings Under GDUFA” that provides information on implementing the new program that was created during recent generic drug user fee negotiations. Such meetings are described as “a meeting with FDA regarding the facility’s remediation of deficiencies identified in a Warning Letter.”

This guidance describes the process for how an eligible facility may request a meeting, how to prepare and submit a complete meeting request package, and how FDA intends to conduct the meeting. The meetings are intended for facilities to obtain preliminary feedback from the agency on the adequacy and completeness of corrective action and preventive action plans to resolve the inspection-identified GMP deficiencies. “Application-related discussions are not appropriate for post-warning letter meetings,” the guidance says, “even if FDA application assessors attend the meeting. The guidance also does not address requests for re-inspections.”