FDA guidance on clinical drug interactions studies with combined oral contraceptives

9 June 2023

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The US Food and Drug Administration (FDA) has published guidance entitled Clinical Drug Interactions Studies with Combined Oral Contraceptives.

This guidance, replacing a draft issued in November 2020, helps sponsors of investigational new drug applications (INDs) and new drug applications (NDAs) evaluate the drug-drug interaction (DDI) effects of their candidates on combined oral contraceptives (COCs).

The advice also helps drugmakers to design DDI studies, and determine how to communicate DDI study results and risk mitigation strategies in labelling, to address potential risks associated with increased or decreased exposure of COCs.

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