FDA’s device center seems agreeable to the concept of “pre-522” study meetings, raised by industry last week as a means to make the post-market study order process more efficient.
The device center will consider interacting with device makers before formally issuing Section 522 post-market study orders to speed up the process and let companies prepare for the mandated studies earlier, CDRH officials said last week.
The idea of “pre-522” meetings was discussed at a March 7 FDA workshop in Silver Spring, Md., on the design and methodology of Section 522 post-market surveillance studies.
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.
