Draft legislation obtained by “The Gray Sheet” that seeks to restrain FDA’s oversight of mobile apps is being circulated for stakeholder comment by Rep. Marsha Blackburn, R-Tenn., and colleagues.
Rep. Marsha Blackburn, R-Tenn., is circulating draft legislation with bipartisan co-sponsors aiming to limit and clarify FDA’s purview over mobile medical apps.
The draft bill obtained by “The Gray Sheet” has been sent to stakeholders in the health information technology space for feedback, with comments due July 12. The lawmakers, including Reps....
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.
