FDA commissioner Robert Califf announces a new transformative vision for the agencys human foods program and the Office of Regulatory Affairs that add...
Federal Register notice: FDA announces the issuance of two Emergency Use Authorizations for diagnostic devices intended for use during the ongoing Mon...
Federal Register notice: FDA classifies software for optical camera-based measurements of pulse rate, heart rate, breathing rate, and/or respiratory r...
FDA classifies as Class 1 a Smiths Medical recall associated with a 12/2022 company-issued urgent medical device correction letter identifying two pot...
FDA posts a final guidance entitled Surveying, Leveling, and Alignment Laser Products that addresses radiation safety product performance standards.
FDA classifies as Class 1 a Medtronic recall of its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a potential leaking conditi...
FDA makes available a draft guidance entitled Acromegaly: Developing Drugs for Treatment.
The U.S. District Court for Southern Florida enters a consent decree of permanent injunction against LGM Pharma and two of the company's executives.
