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Senate Committee Holds Hearing on MDUFA Reauthorization

Wednesday, March 28, 2012  
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The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing this week to discuss the proposed agreement on user fees and other enhancements to FDA's regulatory processes.

The hearing, entitled "FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients," provided testimony from CDRH Director Jeff Shuren and other public officials and stakeholders.

"MDMA thanks the Senate HELP Committee for all of its work to ensure patients and providers have timely access to medical technology innovations," said Mark Leahey, President and CEO of MDMA. "All stakeholders need to continue working towards restoring predictability and transparency with the premarket review process so that tomorrow's innovations are available in the United States first."

To view a recording of the hearing, click here.

The hearing follows similar ones held by the House of Representatives in recent weeks on the various user fee agreements. Both chambers are expected to bring the proposals for a vote in the coming months, with any differences to be worked out in what is known as a Conference Committee.

MDMA is working with FDA officials and Members of Congress as this legislation continues to move forward.