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PDUFA Reaches Approval Altitude; Can House Maintain Senate Speed?

 
• By Derrick Gingery

After about a week of debate, the Senate overwhelmingly passes its FDA user fee package, with only track and trace to be finalized. House members are scheduled to begin floor debate after Memorial Day in the hopes of sending the bill to President Obama before July 4.

Among the lingering questions for FDA supporters coming out of the Memorial Day holiday may be whether the House can continue the relatively swift approval of the user fee package.

The Senate passed its user fee bill, the FDA Safety and Innovation Act, by a 96-1 vote on May 24 in a mostly smooth floor debate. It approved 10 amendments, in addition to the

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More from North America

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