FDA clears a Penumbra 510(k) for an expanded indication for its Indigo Aspiration System treating pulmonary embolisms.
Federal Register notice: FDA announces a 3/27 public meeting entitled Modernizing FDAs Data Strategy.
Federal Register notice: FDA extends until 1/24 the comment period for a draft guidance entitled Certificates of Confidentiality; Guidance for Sponsor...
Federal Register notice: FDA seeks comments on an information collection extension on Focus Groups as Used by the Food and Drug Administration (All FD...
Federal Register notice: FDA extends until 3/23 the comment period on a revised draft guidance entitled Drug Products Labeled as Homeopathic.
Blueprint Medicines begins a rolling NDA submission for pralsetinib after reporting top-line data from a pralsetinib study in patients with RET fusion...
Recipharm staffers discuss the advantages of a quality by design approach to drug manufacturing.
Calling FDAs regulatory system woefully out of date, a Heartland Institute post discusses recent agency executives comments about their staffing chall...