FDA Review post the Federal Register notices for the week ending 5/18/2018.
FDA posts a guidance on Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorder...
FDA approves an Amgen BLA for Aimovig (erenumab), a once-monthly self-injection for preventing migraines in adults.
FDA publishes a draft guidance on Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.
Medtronic recalls its MindFrame Capture LP revascularization device due to wire material that may break or separate during use.
FDA issues a safety alert about decreased survival associated with the use of Mercks Keytruda (pembrolizumab) and Genentechs Tecentriq (atezolizumab) ...
While the Trump Administration sets its sights on slashing spending at various federal agencies, FDA continues to get strong support on Capitol Hill f...
Federal Register final rule: FDA classifies blood establishment computer software and accessories (regulated under product code MMH) into Class 2 (spe...