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GUIDANCE DOCUMENT

Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry Guidance for Industry June 2023

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2020-D-1848
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to help sponsors of investigational new drug applications (INDs) and new drug applications (NDAs) evaluate the drug-drug interaction (DDI) effects of their investigational drugs on combined oral contraceptives (COCs), design DDI studies, and determine how to communicate DDI study results and risk mitigation strategies in labeling to address potential risks associated with increased or decreased exposure of COCs.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1848.

 
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