ARTICLE
3 August 2015

House Of Representatives Passes 21st Century Cures Act

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Jones Day

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On July 10, 2015, the U.S. House of Representatives approved H.R. 6, the 21st Century Cures Act ("Cures Act"), by a vote of 344–77, setting up the legislation for consideration in the U.S. Senate.
United States Food, Drugs, Healthcare, Life Sciences

On July 10, 2015, the U.S. House of Representatives approved H.R. 6, the 21st Century Cures Act ("Cures Act"), by a vote of 344–77, setting up the legislation for consideration in the U.S. Senate. The legislation focuses on reducing regulatory obstacles to the review process through FDA for new pharmaceuticals and medical devices. In general, the Cures Act aims to hasten discovery, development, and delivery of medical products by removing barriers to collaboration, incorporating patients' perspectives into the drug development and review process, modernizing clinical trials, addressing regulatory uncertainty surrounding new medical apps, and incentivizing drug development for rare diseases. While the bill's advance has generally been received with favorable attention, some criticism remains. Earlier in the legislative process, a national association of health care providers sent a letter to lawmakers questioning the viability of the bill's interoperability provisions and the fairness of the enforcement provisions.

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