[ Price : $8.95]
FDA expands the medical device Total Product Life Cycle Advisory Program pilot to include the Office of Neurological and Physical ...[ Price : $8.95]
FDA sends Citius Pharmaceuticals a complete response letter on its BLA seeking approval for Lymphir (denileukin diftitox), indicat...[ Price : $8.95]
Abbott decides to stop selling its Trifecta heart valves due to the potential risk of early structural valve deterioration.[ Price : $8.95]
Federal Register notice: FDA requests comments on an information collection extension entitled Product Jurisdiction and Combinatio...[ Price : $8.95]
FDA posts a final guidance entitled Assessing User Fees Under the Biosimilar User Fee Amendments (BUSFA 3) of 2022.[ Price : $8.95]
GE HealthCare recalls its TruSignal SpO2 Sensors due to malfunction issues that may reduce defibrillation energy or expose patient...[ Price : $8.95]
FDA and Switzerland enter into a mutual recognition agreement where each regulatory agency can rely on each others GMP inspections...[ Price : $8.95]
Under a new pilot program, FDA and the European Medicines Agency complete the first collaborative assessment of a proposed post-ap...