FDA Issues Draft Guidance on Drug Interaction Studies with Combined Oral Contraceptives
Today, the Food and Drug Administration issued a draft guidance for industry, “Clinical Drug Interaction Studies With Combined Oral Contraceptives”. The guidance assists sponsors of investigational new drug applications and new drug applications during drug development in evaluating the need for and design of drug-drug interaction (DDI) studies involving combined oral contraceptives (COCs).
COCs can effectively prevent pregnancy; however, using certain medications at the same time could result in DDIs that affect the safety and effectiveness of COCs.
The draft guidance discusses when drug developers should conduct DDI studies with COCs and provides recommendations on the design and conduct of DDI studies. The guidance also discusses interpreting and communicating the results and recommendations from these studies. For additional information on designing drug-drug interactions studies or labeling, visit the Drug Development and Drug Interactions webpage.
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