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GDF2026 - Office of Pharmaceutical Quality (OPQ) Keynote

Food and Drug Administration (public forum) · July 30, 2026

An FDA presenter reviewed Office of Pharmaceutical Quality and Office of Generic Drugs initiatives, outlining the new PreCheck program, nitrosamine mitigation efforts, the Quality Management Maturity assessments, use of AI and CASA in reviews, and CDER research supporting generic drug access and cost savings.

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