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FDAnews Drug Daily Bulletin
April 27, 2012 | Vol. 9 No. 84
PDUFA Clears Senate Committee; Amendments and House Differences Await
The Senate Health Committee approved its version of an omnibus FDA user fee bill Wednesday, sending it to the Senate floor for a vote as early as next month. While there is only one slight change between the committee-reported version and the manager’s amendment offered by Chair Tom Harkin (D-Iowa), differences are emerging between Senate and House versions. This could complicate agreement on a final bill reauthorizing the Prescription Drug User Fee Act (PDUFA) and enacting user fee programs for generic drugs and biosimilars.
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