FDA Office of Combination Products associate director for policy John Weiner moves to Office of Global Operations director, where he will oversee the ...
Boston Scientific recalls the PolarSheath Steerable Sheath 12F after the company identified a tooling error in manufacturing which may have caused del...
FDA clears a Neuronetics 510(k) for its NeuroStar Advanced Therapy for use as an adjunct for treating major depressive disorder in adolescent patients...
FDA approves the latest version of Medtronics Evolut FX+ system to treat symptomatic severe aortic stenosis.
Two attorneys who represented the Canton, MA-based Judge Rotenberg Center in its court case against FDAs efforts to ban the use of an electroshock or ...
The Biotechnology Innovation Organization suggests ways FDA can improve a draft guidance on potency assurance for cellular and gene therapy products.
FDA releases the form FDA-483 with six observations from an inspection at the Catalent Indiana drug manufacturing facility.
