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GUIDANCE DOCUMENT

Food-Effect Bioavailability and Fed Bioequivalence Studies Guidance for Industry December 2002

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2001-D-0040
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations to sponsors and/or applicants planning to conduct food-effect bioavailability (BA) and fed bioequivalence (BE) studies for orally administered drug products as part of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications.

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

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2001-D-0040.

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