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 The leading web portal for pharmacy resources, news, education and careers July 23, 2017
Pharmacy Choice - Pharmaceutical News - Donnelly, Gardner Introduce Bipartisan Bill to Speed up FDA Approvals for Devices - July 23, 2017

Pharmacy News Article

 5/18/17 - Donnelly, Gardner Introduce Bipartisan Bill to Speed up FDA Approvals for Devices

Washington, D.C. - U.S. Senators Joe Donnelly (D-IN) and Cory Gardner (R-CO) today re-introduced the bipartisan FDA Regulatory Efficiency Act, which would allow the Food and Drug Administration (FDA) to bring innovative medical devices to market more quickly.

Donnelly said, "As scientists and innovators across Indiana and our country work to find new cures and therapies, we should be making it easier for them to bring these products safely to those who need them. I'm proud to work with Senator Gardner on this bipartisan legislation to cut through the red tape at the FDA and safely speed up the approval process."

Gardner said, "We need to be providing the FDA with the necessary resources to get lifesaving medical equipment and technologies to market more quickly, while maintaining safety and efficacy. This legislation is part of a continued effort by Republicans and Democrats to make common sense reforms to speed up the FDA approval process to ensure the government is not getting in the way of our medical and science community."

The FDA Regulatory Efficiency Act would help the FDA concentrate on high-priority activities by authorizing third parties to approve quality systems of device companies. Authorized-third parties could only approve changes that do not involve major technology changes or changes in the use of the product. The legislation would still hold companies accountable for their quality systems, while also helping to alleviate the overwhelmed FDA. Donnelly and Gardner first introduced the legislation in October 2015.

Read this original document at: https://www.donnelly.senate.gov/newsroom/press/donnelly-gardner-introduce-bipartisan-bill-to-speed-up-fda-approvals-for-devices



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