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GDF2026 - Q&A Discussion Panel One

FDA QMM and Generic Drug Office Panel ยท July 30, 2026

A virtual FDA panel answered industry questions about the Quality Management Maturity (QMM) pilot, controlled correspondence procedures for ANDA filers, and technical issues for bioequivalence and filing reviews; officials said QMM assessments are separate from compliance and that company names will be anonymized in published results.

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