Under a new pilot program, FDA and the European Medicines Agency complete the first collaborative assessment of a proposed post-approval change for a ...
A Government Accountability Office review of FDAs over-the-counter drug monograph program performance finds that the agency has not begun receiving an...
Federal Register notice: FDA sends to OMB a new medical device-related information collection entitled Voluntary Improvement Program (VIP).
Federal Register notice: FDA makes available a draft guidance entitled Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Dis...
FDA posts a final guidance entitled Assessing User Fees Under the Biosimilar User Fee Amendments (BUSFA 3) of 2022.
GE HealthCare recalls its TruSignal SpO2 Sensors due to malfunction issues that may reduce defibrillation energy or expose patients to unintended volt...
FDA issues a draft guidance to help sponsors design pivotal clinical trials for innovative medical devices to treat opioid use disorder.
Reuters says FDA documents show sterility issues at the Catalent facility in Brussels, Belgium, that fills Wegovy syringes for Novo Nordisk.
