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House Passes FDA Reform Act

NEW YORK (GenomeWeb News) – The US House of Representatives this week passed the Food and Drug Administration Reform Act, which would reauthorize the Medical Device User Fee Act and implement a number of medical device regulatory reforms, with strong bipartisan support.

The House passed the bill on a vote of 387 to 5, and followed swiftly after the Senate passed its own version of the act last week with overwhelming support.

Under both the House and Senate versions, the act would call for the medical device industry to pay $595 million in user fees between fiscal years 2013 and 2017, and FDA's Center for Devices and Radiological Health would make changes to become more transparent and efficient while streamlining the review process for devices.

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