FDA sends Citius Pharmaceuticals a complete response letter on its BLA seeking approval for Lymphir (denileukin diftitox), indicated for treating pati...
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Federal Register notice: FDA makes available a draft guidance entitled Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Dis...
