Issue Date: March 18, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): Biopharmaceutics
Status: Draft
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations” (draft BA and BE guidance for NDAs). The draft guidance provides recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This draft guidance revises those parts of the March 2003 guidance entitled “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations” relating to BA and BE studies for INDs, NDAs, and NDA supplements.
Download the Guidance Document
