FDA publishes a guidance on CBERs voluntary consensus standards recognition program for regenerative therapy products.
FDA publishes a guidance on considerations about a drugs benefits and risks that the agency applies to certain premarket and postmarket regulatory dec...
FDA grants SeaStar Medical Holding a breakthrough device designation for its cell-directed Selective Cytopheretic Device for use in intensive care uni...
Hamilton Medical recalls its Hamilton-C1, T1, MR-1 ventilators because the capacitators may leak electrolyte fluid onto the ventilators control board....
Harvard Medical School professor Jerry Avorn says recent court decisions banning compelled speech could be interpreted to stop FDA from requiring full...
Seven Gibson Dunn attorneys say the government is pursuing False Claims Act cases involving cybersecurity claims by device manufacturers.
BrainStorm Cell Therapeutics says it is withdrawing a BLA for its NurOwn ALS treatment technology and will work with FDA on a path forward for the tre...
Federal Register notice: FDA posts a list of six information collections that have been approved by OMB.
