President Trump signed an executive order on 9 October that aims for government agency transparency around guidance documents, enforcement, inspections and other areas. But longtime industry expert Steve Niedelman of the law firm King & Spalding says the order will have virtually no impact on how the US FDA conducts business. In fact, Trump's order does nothing to tackle legitimate gripes from industry around things like guidance docs.
A new executive order from President Trump aims for government agency transparency around guidance documents, enforcement, inspections and other areas. But one longtime industry expert says the order will have virtually no impact on how the US Food and Drug Administration conducts business.
That's because the FDA already complies with most – if not all – of what's in the Executive Order on Promoting the Rule of Law Through Transparency and Fairness...
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.
