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, ...
Two CDER executives discuss misconceptions that remain about the meaning and use of real-world data and real-world evidence.
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...