Docket Number:
FDA-2017-D-5961
Issued by:
Guidance Issuing Office
Center 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.

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All written comments should be identified with this document's docket number: FDA-2017-D-5961.