Federal Register notice: FDA announces its process for making available guidance documents related to the coronavirus public health emergency.
FDA accepts for priority review a Jazz Pharmaceuticals NDA JZP-258 (oxybate), an investigational drug for treating cataplexy or excessive daytime slee...
FDA clears an Align Technology 510(k) for the iTero Element 5D Imaging System.
Federal Register notice: FDA announces the process for making available FDA guidance documents related to the coronavirus outbreak.
Federal Register notice: FDA postpones the 4/2-3 Blood Products Advisory Committee meeting.
FDA co-chairs with the EMA a global regulators meeting on developing vaccines to address the Covid-19 pandemic.
FDA warns Chinas Hangzhou Likeweier Daily Chemical Co. about CGMP violations in its production of finished drugs as a contract manufacturer.
FDA warns Denmarks DermaPharm about CGMP violations in its manufacturing of finished drugs.