Variability runs high in FDA’s process for approving new device trials, but the agency is open to recommendations for improvements coming out of its entrepreneurs-in-residence program, says Chip Hance, a former Abbott executive participating in the program.
A group of outside experts working inside CDRH has pinpointed significant variability in how FDA approves new clinical trials and is proposing new agency metrics to improve the investigational device exemption process.
Efforts by participants in the device center’s entrepreneurs-in-residence program are still under way, but FDA officials have so far been receptive to the group’s critiques and recommendations, according to Chip...
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.
