FDA clears NeuroWave Systems NeuroSENSE bilateral brain monitor to assess the adequacy of anesthesia and sedation in clinical settings.
FDA issues a warning about the potential risk of injury associated with the use of Max-Lux Corp.s Safe-T-Lite UV Wand because users and others may be...
FDA approves Mirums Livmarli to treat cholestatic pruritus in patients with Alagille syndrome age one and older.
Magellan Diagnostics recalls its LeadCare II, LeadCare Plus, and LeadCare Ultra blood lead tests due to concerns about false low results.
A panel of FDA staff from CDER and the Office of Regulatory Affairs provide the latest insights into common data integrity inspection findings during ...
CBER director Peter Marks announces he will immediately serve as Office of Vaccines Research and Review (OVRR) acting director, replacing OVRR directo...
Federal Register notice: FDA makes available a draft guidance on developing drugs for treating Nontuberculous Mycobacterial Pulmonary Disease Caused b...
Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission Template for Medical Device 510(k) Submissions.