FDA center directors, including device chief Jeffrey Shuren, told lawmakers they are committed to reauthorizing user-fee programs during a March 21 Senate hearing. The officials wouldn't comment on a recent budget proposal from the Trump administration that seeks more user fees and less appropriations from Congress that industry agreed to.
FDA product-center directors wouldn't comment on whether any alternative user-fee provisions were under consideration during a March 21 Senate hearing, despite a recent budget blueprint from the Trump administration that appears to seek more user fees from companies next year than what industry agreed to in recent negotiations.
FDA Device Center Director Jeffrey Shuren testified before the Senate Health, Education, Labor and Pensions (HELP) Committee on the medical...
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
