FDA: Final Guidance Available on Post-Warning Letter Process for Drug Manufacturing Facilities
The FDA says that final guidance is available on the implementation of the post-warning letter meeting process for certain drug manufacturing facilities, according to a Federal Register notice. Eligible facilities may request a post-warning letter meeting with the FDA on the facility's ongoing remediation efforts to address current good manufacturing practice deficiencies described in the warning letter.
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The effective date for this final guidance is June 20. Processes related to this final guidance are detailed in FDA's program on Generic Drug User Fee Amendments.