FDA grants Restore Medical a breakthrough device designation for its ContraBand device and its use in treating certain heart failures with reduced eje...
FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) 10 mg tablets for relieving heartburn associated with non-erosive gastroesophagea...
FDA says two additional Warning Letters have been issued to Chinese medical device firms as part of its evaluation of defective plastic enteral syring...
FDA publishes a guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balance studies of invest...
Federal Register notice: FDA makes available a final guidance entitled Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy.
Baxter International recalls (Class 1) certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly due to report...
Federal Register notice: FDA extends the comment period on its draft guidance entitled Platform Technology Designation Program for Drug Development....
CDER director Patrizia Cavazzoni and CBER director Peter Marks say they are co-leading a new FDA Rare Disease Innovation Hub.
