Lawmakers push for faster, conditional FDA approval pathway for rare disease drugs
As the FDA tightens its focus on rare disease treatments and speeding their entry to market, lawmakers on Capitol Hill are putting serious stock in a new approval pathway that would speed new treatments for rare diseases to patients even faster.
At a hearing Thursday before the Senate aging committee, Sen. Mike Braun (R-IN) touted his Promising Pathway Act, which would establish a rolling priority review pathway for drugs to treat life-threatening diseases or conditions. The bill, introduced in June by a bipartisan group of senators led by Braun and Kirsten Gillibrand (D-NY), would create a new way for the FDA to grant time-limited provisional approval to drugs that substantially demonstrate early evidence of safety and efficacy.
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