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GUIDANCE DOCUMENT

Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations February 2019

Draft

Not for implementation. Contains non-binding recommendations.

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

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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Assessing the Effects of Food on Drugs in INDs and NDAs—Clinical Pharmacology Considerations.” This draft guidance provides recommendations to sponsors planning to conduct food-effect trials for orally administered products as part of investigational new drug applications (INDs), new drug applications (NDAs), and supplements to these applications. This draft guidance, when final, revises and replaces part of the 2002 FDA guidance for industry entitled “Food-Effect Bioavailability and Fed Bioequivalence Studies” (2002 Food Effect Guidance).


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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:

Division of Dockets Management (HFA- 305)
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.