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NIH Translational Center Should “Raise All Boats,” BIO Says

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NIH Translational Science Center Gets Expanded Powers In Cures Bill

When NCATS was created, industry was wary of allowing Phase III trials; now sponsors embrace it.

NIH’s Translational Science Center Could See Budget Trimmed

Republicans on appropriations subcommittee again seem concerned about whether NCATS will trample industry toes, which could lead to a more tightened focus for the new NIH center’s funding in the upcoming bill.

BIO Wants Expanded Accelerated Approval In PDUFA Instead Of Progressive Approval

While it would not grab as much attention as creating a whole new approval pathway, BIO believes tinkering with accelerated approval to give the regulations more clarity and increase its use still could generate the change it wants at FDA.

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