A Pew Charitable Trusts report praises the FDA 2017 framework on regulation of regenerative medicine as a good first step and says much more needs to ...
Washington Legal Foundation reports on an Idaho state court decision that rejected the legal theory that a branded drug company can be held liable for...
Reps. Pallone and Guthrie introduce bipartisan legislation to allow FDA to partner with universities as National Centers of Excellence in Continuous P...
FDA releases its latest batch of Warning Letters that includes one medical product company PetNet Solutions.
FDA clears a HeartVista 510(k) to use its artificial intelligence-assisted One Click MRI acquisition software for cardiac exams.
FDA warns Petnet Solutions about CGMP violations in its manufacturing of positron emission tomography drugs.
Federal Register notice: FDA announces a 12/3-4 Science Advisory Board to the National Center for Toxicological Research advisory committee meeting.
Federal Register notice: FDA classifies continuous glucose monitor data management systems into Class 1 (general controls).