FDA Issues Draft Guidance for Industry: Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations: Drug Information Update

FDA published a draft guidance for industry entitled, “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations.” This draft guidance provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administered drug products as part of investigational new drug applications (INDs), new drug applications (NDAs), and supplements to NDAs.  This guidance revises and replaces part of the 2002 FDA guidance for industry entitled, “Food-Effect Bioavailability and Fed Bioequivalence Studies.” Other parts are covered in two separate guidances: Information on fed bioequivalence (BE) studies for ANDAs is included in the FDA guidance for industry entitled, “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” and recommendations concerning relative bioavailability assessment are described in the FDA guidance for industry entitled, “Bioavailability Studies Submitted in NDAs or INDs — General Considerations.”