Draft Guidances for Industry Related to Bioavailability Studies and Food Effects

Draft Guidances for Industry Related to Bioavailability Studies and Food Effects

The U.S. Food and Drug Administration (FDA) recently announced the availability of two revised draft guidances related to bioavailability and food effects.

In 2013, FDA divided the 2003 guidance "Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations" and 2002 guidance“Food-Effect Bioavailability and Fed Bioequivalence Studies” into separate recommendations for new and generic drug development.

For generic drug development, information on BE, including fed BE studies, to be submitted in abbreviated new drug applications (ANDAs) is described in FDA’s 2013 draft guidance for industry “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” This guidance is currently being revised and the revised draft is expected to post in 2019.

The two revised draft guidances published recently only include recommendations pertinent to new drug development. FDA is seeking public comment on these two draft guidances.

• Draft guidance for industry entitled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations.” This guidance provides recommendations to sponsors submitting bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements.
• Draft guidance for industry entitled “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations.” This guidance provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administered drug products as part of INDs, NDAs, and supplements to these applications. This guidance revises and replaces the new drug development-related part of the 2002 FDA guidance for industry, “Food-Effect Bioavailability and Fed Bioequivalence Studies.”