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GUIDANCE DOCUMENT

Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry Draft Guidance for Industry November 2020

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

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 need for drug-drug interaction (DDI) studies of their investigational drugs with combined oral contraceptives (COCs), design such studies, and determine how to communicate DDI study results and mitigation strategies to address potential risks associated with increased or decreased exposure of COCs in labeling. This guidance focuses on evaluating the DDI potential of an investigational drug (i.e., perpetrator) on a COC (i.e., victim).

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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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