GUIDANCE DOCUMENT
Post-Warning Letter Meetings Under GDUFA September 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2023-D-3370
- Docket Number:
- FDA-2023-D-3370
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchOffice 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.