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TREAT Act Wants Accelerated Approval Change, But Uses Existing Language

 
• By Derrick Gingery

Anticipated legislation from Sen. Kay Hagan would copy federal regulations outlining accelerated approval to Food, Drug and Cosmetic Act, also encourage use of more broadly effective processes for expedited reviews.

Sen. Kay Hagan’s TREAT Act may do no more to expand the use of the accelerated approval pathway than simply shine more light on the agency’s existing regulations and encourage FDA to implement more effective ways of expediting approvals.

The bill, which the North Carolina Democrat introduced Feb. 15, claims to build on the existing accelerated approval pathway. The...

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