Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry

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

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Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry

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