FDA “Progressive Approval” And “Exceptional Approval” Pathways Possible Under Senate Bill
Legislation being drafted by Sen. Kay Hagan, D-N.C., would formalize FDA practices of approving drugs in certain circumstances where the evidence needed for a standard approval cannot be generated.
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Revisions to the House bill make it nearly identical to sections of Sen. Kay Hagan’s legislation. The debate on PDUFA add-ons will be rejoined at a Commerce Committee hearing, but TREAT now has considerable momentum.
Bill looks to expand accelerated approval rather than create new approval pathways, and also would reform conflict of interest rules for FDA advisory committees.
CDER Director Woodcock says agency should issue internal and external guidance to promote consistent use of the pathway.