An FDA Science Board subcommittee will look for ways to strengthen regulatory systems in emerging economies.
A new FDA Science Board subcommittee will work to "generate some enthusiasm and some momentum" outside FDA for strengthening regulatory systems in developing countries, according to the panel's chair.
The Global Health Subcommittee, formed in April, will assess the level of safety awareness in countries exporting food and medical products to the U.S., and identify promising approaches to strengthening...
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.
