FDA announces the FY 2024 user fee rates for medical device submissions.
Federal Register notice: FDA announces the rates for prescription drug/biologic user fees for fiscal year 2024.
Three Democratic U.S. Senators introduce the Drug Shortages Prevention and Quality Improvement Act that would give FDA and CMS additional authority to...
FDA expands the medical device Total Product Life Cycle Advisory Program pilot to include the Office of Neurological and Physical Medicine Devices.
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...
