post-approval studies Archives

Patient, Consumer, and Public Health Coalition Letter to Congresswoman Dingell Thanking Her for Requesting a GAO Report on Post-market Surveillance of Medical Devices

June 7, 2022: We write to express our gratitude as you work to protect patients by promoting post-market review of approved medical devices. Specifically, we greatly appreciate and value your leadership requesting that the Government Accountability Office (GAO) evaluate the current landscape of post-market surveillance of medical devices.

NCHR Comments on FDA’s Guidance on Post-Approval Pregnancy Safety Studies

June 28, 2019. Currently, 9 in 10 women take at least one medication during their pregnancy, and 7 in 10 women take at least one prescription medication during their pregnancy. It is therefore vital to develop safety profiles of drugs used during any stage of pregnancy. Those studies must be subject to rigorous methodology and surveillance.