FDA grants Limaca Medical a breakthrough device designation for its Precision-GI endoscopic ultrasound biopsy product.
FDA publishes 3 guidances on implementing an International Council on Harmonization guidance on electronic submission of individual case safety report...
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...