FDA issues a draft guidance on the redesignation of the definition of device in the Federal Food, Drug, and Cosmetic Act and the addition of a definit...
Federal Register notice: FDA classifies the nonimplanted nerve stimulator for functional abdominal pain relief into Class 2 (special controls).
Federal Register notice: FDA classifies the endoscopic transhepatic venous access needle into Class 2 (special controls).
Federal Register notice: FDA proposes to require PMAs for spinal spheres for use in intervertebral fusion procedures.
A health and science policy analyst for Citizens Against Government Waste says the Build Back Better act proposed by President Biden will hurt the gen...
Three stakeholders submit comments and questions on a draft International Council on Harmonization guidance on continuous manufacturing.
FDA approves AbbVies JAK inhibitor Rinvoq (upadacitinib; 15 mg, once daily) for treating adults with active psoriatic arthritis who have had an inadeq...
FDA approves a new indication for Bristol-Myers Squibbs Orencia to prevent acute graft versus host disease in combination with immunosuppressants.