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Post-Warning Letter Meetings Under GDUFA September 2023

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-3370

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Office of Regulatory Affairs

This guidance provides information on the implementation of the Post-Warning Letter Meeting process for certain 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 the “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter). A Post-Warning Letter Meeting, as described in section VII(D)(1) of the GDUFA III commitment letter, is a meeting with FDA regarding the facility’s remediation of deficiencies identified in a warning letter. This guidance specifically describes the process 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 current good manufacturing practice (CGMP) deficiencies described in a warning letter, how to prepare and submit a complete meeting request package, and how FDA intends to conduct the Post-Warning Letter Meeting.

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