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).
AstraZeneca announces positive progression-free survival results from the Phase 3 POSEIDON trial in previously-untreated Stage IV non-small cell lung ...
Medtronic gets an FDA Breakthrough Device designation for its fully implantable left ventricular assist device for patients with advanced heart failur...