Post-Warning Letter Meetings Under GDUFA June 2025

GUIDANCE DOCUMENT

• Docket Number: FDA-2023-D-3370
• Issued by: Center for Drug Evaluation and Research; Office of Inspections and Investigations

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Post-Warning Letter Meetings Under GDUFA.” This guidance provides information on the implementation of the Post-Warning Letter Meeting process for certain drug manufacturing facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023--2027” (GDUFA III commitment letter). Specifically, this guidance describes the process detailed in the GDUFA III commitment letter for how an eligible facility may request a Post-Warning Letter Meeting with FDA regarding the facility’s ongoing remediation efforts to address current good manufacturing practice (CGMP) deficiencies described in a warning letter, how to prepare and submit a complete meeting package, and how FDA intends to conduct the Post-Warning Letter Meeting.

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