Bioavailability Studies Submitted in New Drug Applications or Investigational New Drug Applications-General Considerations; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Bioavailability Studies Submitted in NDAs or INDs--General Considerations." This draft guidance provides recommendations to sponsors planning to include bioavailability (BA) information for drug products in investigational new drug applications (INDs),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 This draft guidance revises and replaces FDA's March 2014 draft guidance for industry entitled "Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs--General Considerations," which addresses BA or bioequivalence (BE)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.