Federal Register notice: FDA corrects a 12/21/2023 notice announcing the availability of a final guidance entitled Development of Monoclonal Antibody ...
CDRH director Jeffrey Shuren says the Center will propose down-classifying many in vitro diagnostic tests from Class 3 to Class 2 in the hope of incre...
Some 29 advocacy groups call on FDA to act quickly to finalize a ban on electric skin shock devices used to treat self-injurious or aggressive behavio...
FDA warns Thailands S&J International Enterprises about CGMP violations in its production of finished drugs and refusing to allow some records to be c...
The DC federal court orders FDA to act on a Vanda sNDA for a Hetlioz indication to treat jet lag disorder or schedule a hearing on the submission.
FDA and EMA schedule a 2/1 virtual public discussion on innovative therapies for some cancers to mark World Cancer Day.
FDA sends Defender Pharmaceuticals a complete response letter on its NDA for intranasal scopolamine (DPI-386) for preventing nausea and vomiting induc...
Neuralink founder Elon Musk announces the first chip implant in the brain of a human clinical trial participant.
