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The Medical Device Manufacturers Association requests changes to several aspects of an FDA draft guidance on premarket cybersecuri...[ Price : $8.95]
FDA revises its user fee review action date from 2/28/2025 to 12/29/2024 for a Bristol Myers Squibb BLA for a subcutaneous formula...[ Price : $8.95]
The Advanced Medical Technology Association says FDAs new draft guidance on Requests for Feedback and Meetings for Medical Device ...[ Price : $8.95]
Federal Register notice: FDA issues a final order reclassifying the ultrasound cyclodestructive device, a postamendments Class 3 d...[ Price : $8.95]
Federal Register notice: FDA announces the withdrawal of the Center for Veterinary Medicines Program Policy and Procedures Manual ...[ Price : $8.95]
FDA approves two BLAs for interchangeable biosimilars to Regenerons Eylea (aflibercept) Biocon Biologics Yesafili (aflibercept-jb...[ Price : $8.95]
FDA clears a Meditrina 510(k) for its second generation bipolar radiofrequency Aveta Glo hysteroscopy system.