FDA Urges Inclusive Clinical Trials For Birth Control Medicines

FDA lays out how to establish the safety and efficacy of birth control medicines, including oral contraceptives, long-acting injectables and intrauterine systems (IUSs), in draft guidance published Thursday (July 11). The agency hopes to ensure the products are studied in the most inclusive way possible so that clinical trials reflect how products will actually be used, FDA Principal Deputy Commissioner Amy Abernethy says. The brief, six-page draft guide, explains who should be considered eligible for clinical trials and how long...