The Medical Device Manufacturers Association requests changes to several aspects of an FDA draft guidance on premarket cybersecurity.
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 formulation of Opdivo (nivo...
The Advanced Medical Technology Association says FDAs new draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-S...
Federal Register notice: FDA issues a final order reclassifying the ultrasound cyclodestructive device, a postamendments Class 3 device (product code ...
Federal Register notice: FDA announces the withdrawal of the Center for Veterinary Medicines Program Policy and Procedures Manual Guide 1240.3605 Regu...
FDA approves two BLAs for interchangeable biosimilars to Regenerons Eylea (aflibercept) Biocon Biologics Yesafili (aflibercept-jbvf) and Biogens Opuv...
FDA clears a Meditrina 510(k) for its second generation bipolar radiofrequency Aveta Glo hysteroscopy system.
