Three stakeholders suggest language changes for an FDA draft guidance on submitting a 510(k) for a change to an existing device.
FDA accepts a Bayer BLA for BAY94-9027, an extended half-life PEGylated recombinant human Factor VIII compound for treating hemophilia A in adults and...
Federal Register notice: FDA seeks nominations for a nonvoting industry representative to serve on its Pediatric Advisory Committee.
Federal Register notice: FDA announces an 11/30 public meeting on Assessment of FDA Hiring and Retention that will share high-level findings from a re...
CDRH senior science advisor Heather Agler suggests that medical device manufacturers design their products with interoperability as an objective.
FDA approves a Bausch + Lomb and Nicox NDA for Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%), indicated for reducing intraocular pressure...
Pfizer officials say they have submitted a corrective and preventative action plan to FDA on remediating GMP issues at Hospira legacy facilities, and ...
The Lancet Oncology Commission outlines future cancer research priorities for the U.S. Cancer Moonshot.