Federal Register notice: FDA sends to OMB an information collection extension entitled Electronic User Fee Payment Request Forms Form FDA 3913 and Fo...
After four deaths were reported, Kezar Life Sciences suspends the enrollment of new patients and dosing of ongoing patients in its lupus nephritis Pha...
Federal Register notice: FDA makes available four final device-specific guidance documents for the Safety and Performance Based Pathway.
Johnson & Johnson files a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) for a new indication combination use with bortezo...
Smiths Medical recalls (Class 1 device correction) its ParaPAC Plus P300 and P310 Ventilators due to inadvertent tidal volume knob movement.
FDA awards de novo marketing clearance to Germitecs Chronos automated disinfection device for reducing the risk of cross-contamination with ultrasound...
Federal Register notice: FDA makes available a final guidance entitled Clarification of Radiation Control Regulations for Manufacturers of Diagnostic ...
FDA commissioner Robert Califf and other top officials outline areas the agency believes can be optimized to help improve the advice received from adv...
