FDA guidance: M9 biopharmaceutics classification system-based biowaivers

14 May 2021

The US Food and Drug Administration has published the guidance for industry entitled “ M9 Biopharmaceutics Classification System-Based Biowaivers,” a draft of which was issued in October 2018. The guidance provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of the in vivo bioequivalence study requirement for drug products.

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