FDA Issues Draft Guidance for Industry on Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy

Today the U.S. Food and Drug Administration is issuing the draft guidance “Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.” This guidance provides applicants with recommendations on key design features to consider for clinical trials to help facilitate development of hormonal contraceptives. Specifically, the draft guidance recommends enrollment criteria and study elements, as well as safety and effectiveness considerations for these clinical trials. This guidance does not provide development information on nonhormonal contraception (contraceptive devices) or emergency contraception.

FDA seeks comments on this draft guidance. Please refer to the guidance for more details.

Additional information is available in the FDA In Brief and Federal Register notices.