The Department of Justice says its top priority for corporate criminal enforcement is individual accountability by targeting the individuals who commi...
Federal Register notice: FDA seeks patient advocate applications to participate under its collaboration with the Clinical Trials Transformation Initia...
Federal Register notice: FDA determines that Hoffmann-La Roches Endep (amitriptyline HCl) was not withdrawn from sale for safety or effectiveness reas...
Roche gains FDA 510(k) clearance for the cobas pure integrated solutions, the next generation of its cobas diagnostics platform.
FDA clears a ClearPoint Neuro 510(k) for its version 2.1 of the ClearPoint Neuro Navigation software.
CDRH updates a 4/27 letter to health care providers to ensure those in operating room settings are aware of a Medtronic recall of endotracheal tubes.
HHS details specific FDA projects that will be undertaken as part of President Bidens recent Executive Order launching a National Biotechnology and Bi...
Federal Register notices: FDA publishes three notices about its most recent periodic reassessment of the definition of small number of animals for min...
