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GUIDANCE DOCUMENT

Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations June 2022

Final
Docket Number:
FDA-2018-D-4368
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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).


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-4368.

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