Federal Register notice: FDA announces a 4/16 public meeting entitled Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Cli...
Federal Register notice: FDA reopens the comment period indefinitely on a notice seeking scientific data and information about the safety, manufacturi...
Federal Register notice: FDA makes available a final guidance entitled 510(k) Third Party Review Program.
B. Braun asks FDA to assign AP therapeutic equivalence codes to some of its injectable products in the Orange Book.
FDA clears an Ossio 510(k) for its OssioFiber Hammertoe Fixation System for maintenance of alignment and fixation of bone fractures, osteotomies, arth...
FDA issues a safety alert on potential infection risk from using fecal microbiota for transplantation to treat C. difficile infections.
Alston & Bird reviews provisions in FDAs announcement postponing foreign inspections and offers guidance to regulated industry.
FDA grants Boehringer Ingelheim and Eli Lilly a fast track designation for Jardiance (empagliflozin) and its use to reduce the risk of kidney disease ...