Biden’s ‘Advanced Research’ Agency May Have Pros And Cons, Congressional Research Service Concludes
CRS poses series of questions about how a new federal agency tasked with speeding translational research for treating high-impact diseases would work, including potential downsides and whether it would duplicate government programs already in place.
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ARPA-H could be a solution to some of FDA’s long-running complaints about US clinical trial infrastructure, the agency's cancer chief says.
Need For Advanced Manufacturing Technologies A ‘Great Learning’ From The Pandemic, CBER’s Marks Says
COVID-19 highlighted limited domestic capacity and need for more flexibility, agility and reliability in manufacturing processes, says FDA biologics center director Peter Marks; he also discussed differences in data review for vaccine BLAs relative to EUAs.
Reps. Diana DeGette and Fred Upton are looking to President Biden and his new plan for a translation health research group at NIH to get their next itineration of 21st Century Cures across the finish line. A discussion draft is expected in early June.