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FDA “Progressive Approval” And “Exceptional Approval” Pathways Possible Under Senate Bill

Executive Summary

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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Accelerated Approval Legislation Picking Up Speed; ULTRA Becoming FAST

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.

Hagan Introduces Long-Anticipated TREAT Act, Sans Progressive, Exceptional Approval

Bill looks to expand accelerated approval rather than create new approval pathways, and also would reform conflict of interest rules for FDA advisory committees.

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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