Medtronic issues an urgent field safety notice about the potential for navigational inaccuracy when its O-arm O2 Imaging Systems auto-registration fea...
Fusion IV Pharmaceuticals (dba Axia Pharmaceutical) recalls all unused sterile drug products within expiry due to a lack of sterility assurance.
Bipartisan House Energy and Commerce Committee ask FDA to provide information on the agencys approval performance on complex generic drugs, saying the...
TG Therapeutics begins a rolling NDA submission for umbralisib, a dual inhibitor of PI3K-delta and CK1-epsilon for treating patients with previously t...
Federal Register notice: FDA submits to OMB an information collection extension for BLA general licensing provisions.
CDRH electrical engineer Lowell Howard explains in a CDRH Learn video how manufacturers and importers can comply with the FDA electronic product radia...
FDA sets a 3/5 public workshop entitled Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine.
Mindbreeze says it is working with Booz Allen to give CDER regulatory review search capabilities.