Federal Register notice: FDA and HHS withdraw a 1/15 notice that proposed exemptions for 83 Class 2 devices and one unclassified device from 510(k) pr...
FDA grants Qorvo an emergency use authorization for the Qorvo Omnia SARS-CoV-2 Antigen Test.
The Justice Department says two men who operated Genesis Herb, a dietary supplement manufacturer in Ohio, intend to plead guilty to multiple FDA charg...
Federal Register notice: FDA sends to OMB an information collection extension entitled Premarket Notification for a New Dietary Ingredient.
Federal Register notice: FDA submits to OMB an information collection extension entitled Regulations for In Vivo Radiopharmaceuticals Used for Diagnos...
Federal Register notice: FDA issues an order permanently debarring Mark Reinhard from providing services in any capacity to a person that has an appro...
The ALS Association calls on FDA to act with more urgency on approval of Amylyx AMX0035 that reported a successful Phase 2 trial.
FDA posts several new postmarket activity modules on its CDRH Learn Web page.