[ 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 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...[ Price : $8.95]
A Government Accountability Office review of FDAs over-the-counter drug monograph program performance finds that the agency has no...[ Price : $8.95]
Federal Register notice: FDA sends to OMB a new medical device-related information collection entitled Voluntary Improvement Progr...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Clinical Considerations for Studies of Devices Intended to ...