Federal Register notice: FDA issues a priority review voucher to Pfizer after determining that its Paxlovid tablets meet the criteria for a material t...
Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) urge the Department of Justice to rescind its Office of Legal Counsels 2019 opinion blocking F...
Federal Register notice: FDA permanently debars Jessica Palacio from providing services to any person that has approved or pending drug product applic...
Philips Respironics recalls (Class 1) its OmniLab Advanced + Ventilator because the device may experience an interruption or loss of therapy.
An FDA advisory committee recommends the approval of a Guardant Health PMA for the Shield blood test for colorectal cancer screening in adults age 45 ...
Pfizers Hospira drug unit recalls (Class 1) several lots of buprenorphine HCl injection Carpuject units and labetalol HCl injection Carpuject units du...
Vyaire Medical recalls (Class 1) its Twin Tube sample lines, which are used on the Vyntus CPX Cardiopulmonary Exercise Test, due to the potential for ...
Federal Register notice: FDA makes available a draft revised guidance entitled Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human...