Drugs

Oral Contraceptive Drug Interaction Guidance

FDA has published a guidance, Clinical Drug Interaction Studies with Combined Oral Contraceptives, to help sponsors of INDs and NDAs evaluate the drug-drug interaction (DDI) effects of their investigational drugs on combined oral contraceptives (COCs), design interaction 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. The document focuses solely on specific recommendations relevant to metabolism-based DDIs with COCs. Other mechanisms that can cause an interaction, such as absorption-based, are not addressed in the guidance but should be considered by sponsors and investigators, FDA says.

Also, the agency says, the guidance does not discuss interactions with progestin-only pills and contraceptives administered via non-oral routes, such as transdermal systems.

The guidance contains an Introduction, Background, When COC DDI Studies Should be Conducted, Design and Conduct of Clinical COC DDI Studies, Interpreting the Results of Clinical COC DDI Studies, Extrapolating the Results of Clinical COC DDI Studies, Labeling Recommendations, Abbreviations, Definitions, and an Appendix.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome