FDA Issues Draft Guidance for Industry on Bioavailability Studies Submitted in NDAs or INDs — General Considerations: Drug Information Update

The FDA published a draft guidance for industry entitled, “Bioavailability Studies Submitted in NDAs or INDs — General Considerations.” This draft guidance provides recommendations for evaluation of bioavailability (BA) for orally administered drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements.   This guidance contains advice on how to meet the BA requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for oral administration. The guidance is also applicable to non-orally administered drug products when it is appropriate to rely on systemic exposure measures to determine the BA of a drug (e.g., transdermal delivery systems and certain rectal and nasal drug products). The guidance provides advice on conducting relative BA studies during the IND period for a drug intended to be submitted for approval in an NDA and bioequivalence (BE) studies during the post approval period for certain changes to drug products.   When finalized, this guidance will revise and replace the FDA’s March 2014 draft guidance for industry entitled, “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations,” which addresses BA or BE studies for INDs, NDAs, and NDA supplements.