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GUIDANCE DOCUMENT

Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications Guidance for Industry October 2017

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance helps sponsors of investigational new drug applications and applicants of new drug applications evaluate drug-drug interactions (DDIs) during drug development and communicate the results and recommendations from DDI studies.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.