GDF2026 - Bioequivalence (BE) Recommendations for Bridging Pre- and Post-Mitigation Formulations
Office of Bioequivalence, Office of Generic Drugs · July 30, 2026
FDA Office of Bioequivalence staff presented recommendations for bioequivalence data when drug products are reformulated to mitigate nitrosamine impurities and illustrated the guidance with four hypothetical case studies, emphasizing case-by-case evaluation and early engagement with the agency.
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