Federal Register Notice: FDA is making available a draft guidance for industry entitled Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations. It provides recommendations to sponsors and/or applicants planning to include bioavailability and bioequivalence information for drug products in INDs, NDAs, and NDA supplements. The document revises those parts of the 3/2003 guidance entitled Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations. To download this guidance, click here. To view this notice, click here.