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

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.

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.