Latest From Michael McCaughan
The Biden Administration’s signature health research agency ARPA-H is still in the formative stages. Authorizing legislation moving through Congress could set up a very interesting dynamic when it comes to working with the US FDA.
US FDA’s push to re-think oncology dosing should begin by renaming the initial human trials to de-emphasize toxicity, a National Cancer Institute official suggests.
The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.
The House Energy & Commerce Committee is moving rapidly to complete work on a bipartisan reauthorization of the US FDA’s user fee programs – and it isn’t waiting for any riders that aren’t ready on time. For now, at least, that means the CURES 2.0 bill will have to find another track.
The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.
The draft bipartisan user fee reauthorization bill includes more than 40 ride-along provisions to make changes at the US FDA. But there are at least three other bills moving in Congress that also make FDA reforms.