[ Price : $8.95]
Three stakeholders suggest language changes for an FDA draft guidance on submitting a 510(k) for a change to an existing device.[ Price : $8.95]
FDA accepts a Bayer BLA for BAY94-9027, an extended half-life PEGylated recombinant human Factor VIII compound for treating hemoph...[ Price : $8.95]
Federal Register notice: FDA seeks nominations for a nonvoting industry representative to serve on its Pediatric Advisory Committe...[ Price : $8.95]
Federal Register notice: FDA announces an 11/30 public meeting on Assessment of FDA Hiring and Retention that will share high-leve...[ Price : $8.95]
CDRH senior science advisor Heather Agler suggests that medical device manufacturers design their products with interoperability a...[ Price : $8.95]
FDA approves a Bausch + Lomb and Nicox NDA for Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%), indicated for reducing ...[ Price : $8.95]
FDA releases a draft guidance incorporating GDUFA 2 revisions on generic drug development controlled correspondence.[ Price : $8.95]
FDA clears an IntraFuse 510(k) for its FlexThread Fibula Pin System that is intended to provide percutaneous fixation of distal fi...