May 30, 2012, WASHINGTON, DC--- The Food & Drug Administration Reform Act of 2012 (FDARA) was passed today by the U.S. House of Representatives. This bill contains numerous provisions that will enhance the review of promising new therapies for unmet medical needs, support the Rare Disease Program at FDA, and modernize the regulation of devices for use by small patient population.
The legislation contains the most comprehensive improvements to public policy for rare disease therapies since the Orphan Drug Act and also reauthorizes the user fees that support FDA review of new medical products.
“Today we join our allies throughout the health care community in thanking Chairman Upton and Ranking Member Waxman along with other House leaders for working together over many months to pass this momentous legislation,” said Peter L. Saltonstall, NORD President and Chttp://www.blogger.com/img/blank.gifEO. “It is ultimately patients and their families who will benefit most from the substantive policy in the Food and Drug Administration Reform Act of 2012. These reforms, once agreed to by both chambers of Congress and signed into law by the President, will herald even greater investment and innovation in the development of rare disease therapies.”
Read NORD's press release on the Senate Bill.
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