CDRH issues an Early Alert after becoming aware that GE HealthCare sent a letter alerting affected customers of updated use instructions for Portrait ...
Boston Scientific recalls its ENROUTE Transcarotid Neuroprotection System Plus, a single-use percutaneous catheter kit used during transcarotid artery...
FDA Digital Health Center of Excellence director Rick Abramson outlines an agency white paper on developing and using digitally derived measures in cl...
Medline issues a device correction (Class 1 recall) for convenience kits containing B. Brauns bupivacaine hydrochloride components.
Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmation seems unlikely.
FDA warns Gilbert, AZ-based Suretec Innovations about CGMP and drug listing violations in its manufacturing of finished drugs.
FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.
FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and children eight years and ...
