Clinical Drug Interaction Studies With Combined Oral Contraceptives; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Clinical Drug Interaction Studies With Combined Oral Contraceptives." This guidance is intended to help sponsors of investigational new drug applications and new drug applications evaluate the need for drug-drug interaction (DDI) studies with combined oral contraceptives (COCs), design such studies, and determine how to communicate DDI study results and risk mitigation strategies to address potential risks associated with increased or decreased exposure of COCs in labeling. The guidance finalizes the draft guidance "Clinical Drug Interaction Studies With Combined Oral Contraceptives" issued on November 23, 2020.