Cures 2.0 Leaders Sees Biden ‘Advanced Research’ Project As Ticket To Bill’s Success
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.
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Clinical Trial Diversity Measures Primed For Inclusion In US FDA User Fee Legislation
House subcommittee hears testimony on merits of various proposals to increase diversity of clinical trial participants; whether lawmakers ultimately favor measures that impose enforceable obligations on sponsors, or merely incentivize more diverse enrollment, remains to be seen.
‘A Game Changer:’ Cures 2.0 Would Provide $11bn In ‘Subscription’ Contracts For New Antibiotics
The PASTEUR Act would delink some of an antibiotic’s revenue from prescription sales, with the goal of revitalizing the antibiotic pipeline with additional private investment while encouraging good public health stewardship of critically needed medicines.
FDA’s Pazdur Believes ‘Advanced Research’ Project Could Address Trial ‘Wastefulness’
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.