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This (2019) draft guidance provides recommendations to sponsors planning to include bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements.
This draft guidance revises and replaces FDA’s March 2014 draft guidance for industry entitled “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations,” which addresses BA or bioequivalence (BE) studies for INDs, NDAs, and NDA supplements.