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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This final guidance helps sponsors of investigational new drug applications and applicants of new drug applications evaluate drug-drug interactions (DDIs) during drug development and determine essential information to communicate in labeling.
This final guidance describes clinical studies to evaluate the DDI potential of an investigational drug, including: (1) the timing and design of the clinical studies; (2) the interpretation of the study results; and (3) the options for managing DDIs in patients. Specifically, this guidance provides considerations for evaluating pharmacokinetic cytochrome P450 (CYP) enzyme- or transporter-mediated interactions.
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:
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-2017-D-5961.