Details Basic Details Status Complete Last Updated Tuesday, May 27, 2025 Original Posting Date Monday, September 24, 2018 Health Outcome(s) arterial thromboembolism (ATE), venous thromboembolism (VTE) Purpose Drug and Outcome Analysis Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR Yes Result(s) (1) Venous and Arterial Thromboembolism among New Users of NuvaRing and Other Combined Hormonal Contraceptives: A Descriptive Analysis Regulatory Link(s) (1) FDA Approval Package Materials