AGDD 2025 | D2S04 – Session 4: Q&A Discussion Panel
FDA Q&A Panel (Session 4) · June 11, 2026
A Q&A panel at an FDA session addressed applying a proposed BCS Class 4 framework to generic drug evaluation and detailed agency expectations for nitrosamine testing, acceptable intake (AI) limits, bioequivalence comparators and formulation changes. Panelists included FDA scientists from the Office of Generic Drug and Office of Pharmaceutical Quality.
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