NDA, IND Bioavailability Studies Guidance

FDA has published a guidance, Bioavailability Studies Submitted in NDAs or INDs — General Considerations, with recommendations on how sponsors can meet bioavailability requirements as they apply to dosage forms intended for oral administration. The document also applies to non-orally administered drug products when it is appropriate to rely on systemic exposure measures to determine the bioavailability of a drug.

This guidance finalizes a 2/2019 draft that had replaced a 3/2014 guidance. FDA says it considered comments received on the 2014 guidance when issuing the 2019 draft. “FDA recognizes that this guidance cannot address every issue pertaining to the assessment of bioavailability studies for INDs and NDAs,” FDA says. “Therefore, sponsors are encouraged to contact the appropriate review division with specific questions not addressed by this guidance.”