Vision Advocacy president Paula Cofer writes FDA commissioner Robert Califf urging regulatory action against refractive eye surgery providers who have...
Writing in a 5/2 online JAMA viewpoint, senior FDA officials prepare the agency and the public to accept that Covid-19 infections and upcoming seasona...
Federal Register notice: FDA announces a 6/17 Psychopharmacologic Drugs Advisory Committee meeting to vote on an Acadia Pharmaceuticals resubmitted su...
FDA warns the Oxford, OH-based Miami University Department of Chemistry and Biochemistry contract testing laboratory about CGMP deviations in its test...
Federal Register notice: FDA sends to OMB an information collection extension entitled Administrative Detention and Banned Medical Devices.
FDA sends HutchMed a complete response letter on its NDA for surufatinib, indicated for treating pancreatic and extra-pancreatic neuroendocrine tumors...
FDA denies a Public Citizen petition calling for the disqualification of two researchers at Hennepin County Medical Center, Minneapolis, MN, who repea...
Federal Register notice: FDA issues Regeneron Pharmaceuticals a priority review voucher under its material threat medical countermeasure product progr...