Hagan Introduces Long-Anticipated TREAT Act, Sans Progressive, Exceptional Approval
This article was originally published in The Pink Sheet Daily
Bill looks to expand accelerated approval rather than create new approval pathways, and also would reform conflict of interest rules for FDA advisory committees.
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At user fee hearing, PhRMA’s Wheadon counters questions from Rep. Dingell, saying FDA already is receiving resources to conduct GMP inspections outside the U.S.
Commissioner Hamburg says the agency likely does not need legislation to improve its conflict of interest policy, but House members still say system needs reform.
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.