The Senate confirmed Robert Califf as the new FDA commissioner after months of delay, giving the cardiologist, clinical trial expert and established agency official a better platform to push his priorities, which include combination product and clinical data-collection reforms, while implementing projects already under way.
Robert Califf became the first cardiologist to serve as commissioner of FDA with an 89-4 vote of support in the Senate on Feb. 24.
He will replace acting commissioner Stephen Ostroff, who is expected to remain in the Office of the Commissioner during the transition.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
