FDA clears a Baze 510(k) for its at-home blood collection process and its use to assess blood nutrient status.
FDA gives Medtronic approval to proceed with an IDE trial (PULSED AF) to evaluate the safety and effectiveness of its PulseSelect Pulsed Field Ablatio...
Wisconsin cardiologist Nalini Rajamannan contacts FDA commissioner Stephen Hahn over the agencys decision not to provide information to patients who w...
Federal Register notice: FDA seeks comments on an information collection extension for Reporting Associated With Animal Drug and Animal Generic Drug U...
Federal Register notice: FDA seeks comments on an information collection extension for Electronic Products 21 CFR Parts 1000 Through 1050.
Federal Register notice: FDA determines that Chiesi USAs Cardene (nicardipine hydrochloride) injection, 25 mg/10 ml, was not withdrawn from sale for s...
FDA publishes a guidance on changes in the Biosimilar User Fee program.
FDA highlights potential cybersecurity vulnerabilities in some GE Healthcare Clinical Information Central Stations and Telemetry Servers.