FDA issues a Warning Letter to Abington Memorial Hospitals institutional review board after a bioresearch monitoring inspection found violations.
GE Healthcare recalls its Giraffe and Panda i-Res Infant Warmers because the bedside panels and latch areas of the warmers can crack or break if the u...
FDA clears an Icotec 510(k) for the Vader One pedicle screw system for spine surgical procedures.
Janssen Pharmaceutical Companies files a BLA for Darzalex (daratumumab) that seeks approval of a new subcutaneous formulation for treating certain pat...
Federal Register notice: FDA cancels an 8/8-planned public workshop on developing antiviral drugs for treating adenoviral infection.
Federal Register notice: FDA makes available a guidance entitled Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials...
Federal Register notice: FDA makes available a draft guidance entitled Harmonizing Compendial Standards with Drug Application Approval Using the USP P...
Federal Register notice: FDA makes available a draft guidance entitled Using the Inactive Ingredient Database.