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FDA makes available a draft guidance entitled Acromegaly: Developing Drugs for Treatment.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.
FDA extends by three months its review of an Argenx BLA for subcutaneous efgartigimod for treating adult patients with generalized myasthenia gravis.
CDER and CBER say that beginning 2/13 they will restart limited in-person, face-to-face industry meetings.
