FDA Nitrosamine Guidance 2024: Implementation of Control Strategies and Bioequivalence Approaches

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Author/sZuk, Susan; Lu, Dongmei
Date:11/07/2024
Meeting Name:FDA and the Center for Research on Complex Generics (CRCG) Workshop on Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products
State:MD
City:Rockville