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FDA makes available a draft guidance entitled Acromegaly: Developing Drugs for Treatment.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.
Eleven-year Oracle veteran Troy Tazbaz joins FDA as Digital Health Center of Excellence director, replacing Bakul Patel who left the agency last May t...
Federal Register notice: FDA seeks comments on an information collection revision entitled Premarket Approval of Medical Devices.
