What is the 21st Century Cures Act?

The 21st Century Cures Act was signed into law on December 13, 2016. The bill serves to increase the speed with which medical products can be developed. The goal is to bring new medical advances to patients who need them much more quickly than was possible in the past.

So what does the bill do, exactly? Here’s a quick breakdown:

  • Improve data-sharing across biopharma
    To encourage cooperation among clinical researchers, the bill removes regulatory barriers to sharing health-related information, including data generated on mobile health apps. The goal is to nurture collaboration among biopharmaceuticals.
  • Refocus research on biomarkers, personalized medicine
    The proposed legislation would shift the focus of research to finding key biomarkers for a variety of conditions. It would allow researchers to use genomic data for pre-screening, explore new trial designs, and access patient-created health registries.
  • Help the FDA become more patient-centric
    Patients would be able to share their experiences with the FDA directly in both pre- and post-market monitoring of new drugs. This interaction would flow through existing regulatory channels, as well as social media platforms.
  • Boost funds for the NIH and FDA
    Alongside a yearly appropriation to the FDA of $110 million for the next half-decade, the bill would offset $1.75 billion annually for an “Innovation Fund” that seeks to spur the development of groundbreaking treatments.

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Source: http://1.usa.gov/1ShSPxc; http://bit.ly/1IyT6ry

ClinEdge Staff

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