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: NCHR public comment urges FDA to require safety studies of drugs taken during or after pregnancy that include women of all races, ethnicities and access to insurance. FDA should require better tracking of medication risks, and ensuring that research represents all races, ethnicities, and insurance types (including uninsured women and those on Medicaid). With 9 out of 10 pregnant women taking medications, we need better safety data to protect both mothers and babies.