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User-Fee Bill Advances With Broad Support, Additional Device Reforms

 
• By Sue Darcey

The US Senate Health, Education, Labor, and Pensions Committee approved the FDA Reauthorization Act, reauthorizing drug and device user fees and multiple additions device regulation reforms, on a 21-2 vote. The mark-up session also gave HELP members from both parties a chance to vent about provisions they'd want to see in a Senate version of an Affordable Care Act repeal bill.

The Senate HELP Committee agreed May 11, on a 14-2 vote, to move user-fee reauthorization legislation to the Senate floor.

The FDA Reauthorization Act (FDARA) that would enact the MDUFA IV user-fee agreement, and put into place an array of previously introduced, additional reforms related to device facility inspections, accessories,...

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