[ Price : $8.95]
AbbVie submits a supplemental NDA for Rinvoq and its use in treating adult patients with giant cell arteritis.[ Price : $8.95]
FDA publishes draft guidances with recommendations on 510(k) submissions for dental composite resins and curing lights.[ Price : $8.95]
Hamilton Medical recalls its software for the Hamilton-C6 Medical Ventilator because the ventilator may fail to restart ventilatio...[ Price : $8.95]
FDA says Baxter is recalling its Life2000 ventilators that were distributed in the U.S. between 8/2023 and 4/2024 due to potential...[ Price : $8.95]
Federal Register notice: FDA provides notice that a patent infringement lawsuit has been filed against Amgen over its BLA submissi...[ Price : $8.95]
Federal Register notice: FDA makes available final guidance entitled Clinical Considerations for Studies of Devices Intended To Tr...[ Price : $8.95]
FDA releases the form FDA-483 with three observations issued following an inspection at the Hikma outsourcing facility in Cherry H...[ Price : $8.95]
The Duke-Margolis Institute for Health Policy issues a summary with five broad themes from a meeting co-sponsored with FDA on incr...