Three Drinker Biddle attorneys caution drug companies to consult a recent FDA final guidance on REMS modifications and revisions to be sure distributi...
FDA clears a Siemens Healthineers 510(k) for three modules of its AI-Rad Companion Chest CT, a software assistant that brings artificial intelligence ...
FDA approves an expanded indication for AbbVies hepatitis C drug Mavyret.
CDRH director Jeffrey Shuren says FDA would like to hear from companies if they would be comfortable having the agency make medical device breakthroug...
FDA approves Abbotts Proclaim XR recharge-free neurostimulation system for people with chronic pain.
Researchers say the magnitude of treatment effects is higher among drugs and medical devices approved through accelerated pathways than in those for w...
FDA renews Certaras legacy licenses for its GlobalSubmit drug and biologics review software for another year.
Federal Register notice: FDA determines that Hospiras atropine sulfate ansyr plastic syringe was not withdrawn due to safety or effectiveness reasons....