This report was first published by Endpoints News. To see the original version, click here
As China sees increased biotech investments, licensing deals and faster early-phase clinical trial starts, FDA Commissioner Marty Makary said his agency is reworking Phase 1 trial regulations to speed that entry process and tweaking user fees to encourage R&D in the US.
“We can come up with some protection strategies, but ultimately, what we need to do is be more competitive with what’s going on with Phase 1s” and investigational new drug applications, Makary told the All-In podcast in a nearly 90-minute interview, referring to the way China has increasingly sped up the activation of new early-phase trials.
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