Issue Date: May 20, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Pharmacology
Status: Final
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 under investigational new drug applications (INDs) to support new drug applications (NDAs) and supplements to these applications for drugs being developed under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). This guidance revises and replaces part of the 2002 FDA guidance entitled Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002). Information on fed bioequivalence (BE) studies to be submitted in abbreviated new drug applications (ANDAs) is now found in the FDA guidance entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (August 2021). Specific recommendations concerning fed comparability studies are now described in the FDA guidance entitled Bioavailability Studies Submitted in NDAs or INDs — General Considerations (April 2022). Additional Guidance Resources:Food Effects Guidance SnapshotFood Effects Guidance Recap PodcastFood Effects Guidance Recap Podcast Transcript
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