U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry January 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
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.

Additional Guidance Resources:

Submit Comments

Submit Comments Online

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:

Dockets Management
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.

 
Back to Top