Abbott decides to stop selling its Trifecta heart valves due to the potential risk of early structural valve deterioration.
Federal Register notice: FDA requests comments on an information collection extension entitled Product Jurisdiction and Combination Products 21 CFR P...
FDA and Switzerland enter into a mutual recognition agreement where each regulatory agency can rely on each others GMP inspections of a pharmaceutical...
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Federal Register notice: FDA makes available a draft guidance entitled Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Dis...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.
