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Latest Senate Draft PDUFA Rider Would Let Drugmakers Request Accelerated Approval

April 6, 2012
The Senate has released its draft of a bill on accelerated approval changes, largely mirroring Sen. Kay Hagan’s (D-N.C.) TREAT Act and giving a strong indication of what could come in a final FDA user fee bill. The Transforming the Regulatory Environment to Accelerate Access to Treatments Act, or TREAT Act (S. 2113), mostly clarifies the statute on the FDA’s current accelerated approval process but — unlike before — would allow sponsors to request the designation themselves.
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