GDF2026 - Updates on Nitrosamines/ Nitrosamine Mitigation Strategies for Pharmaceuticals
FDA briefing / Office of Pharmaceutical Quality Research presentations · July 30, 2026
Lynn and Dr. Shaquille presented FDA research and regulatory guidance on nitrosamine control in drug products, covering recommended AI limit tables, interim limits for shortage mitigation, ANDA progress-update requirements, observed common deficiencies in industry submissions, and laboratory mitigation studies including metformin case work.
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