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.
Sens. Hassan and Braun call on FDA commissioner Robert Califf to quickly lead a revision of opioid drug labeling.
FDA removes a clinical hold on Pfizers giroctocogene fitelparvovec (Hemophilia A gene therapy); the company plans to resume dosing in its AFFINE trial...
FDA proposes issuing a second Section 518(b) order against Philips Respironics, this time to require the company to submit a plan to repair, replace, ...