On July 10, 2015, Congress passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344 to 77. The 352-page bill seeks to make the U.S. Food and Drug Administration (FDA) drug and device approval process less onerous to expedite patient access to new treatments and cures. The final bill aims to USA-map-Colouraccomplish this goal through several provisions. During the review of a new drug, the bill requires the FDA to consider patient experience data in the drug’s benefits and risks assessment. The bill creates a structured framework to qualify drug development tools, such as biomarkers. The bill also streamlines the institutional review board process for trials that are being conducted at multiple locations in order to eliminate duplication in the review process.
The bill simplifies the review process for new purposes of previously approved drugs.
Medical device companies could also benefit from this bill. The bill clarifies that for FDA approval of medical devices, evidence such as registry data, studies published in peer review journals, and data collected in countries other than the United States can be considered under certain circumstances.
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