The notices normally would go out on 1 August, but unspent user fee funds may be able to sustain work for a few weeks if the program expires.
Lay-off notices for US Food and Drug Administration employees are expected to go out in about a month, rather than this week, if the impasse holding up the user fee reauthorization is not resolved.
The agency told Medtech Insight that it has targeted early September to notify employees of the potential consequences of no user fee program extension. Should Congress fail to renew the...
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.
