GUIDANCE DOCUMENT
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations February 2019
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2018-D-4368
- Issued by:
-
Guidance Issuing OfficeCenter 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Assessing the Effects of Food on Drugs in INDs and NDAs—Clinical Pharmacology Considerations.” This draft guidance provides recommendations to sponsors planning to conduct food-effect trials for orally administered products as part of investigational new drug applications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 This draft guidance, when final, revises and replaces part of the 2002 FDA guidance for industry entitled “Food-Effect Bioavailability and Fed Bioequivalence Studies” (2002 Food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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All written comments should be identified with this document's docket number: FDA-2018-D-4368.