The 21st Century Cures Act (Cures Act)

The 21st Century Cures Act (Cures Act) was signed into law on December 13, 2016.  It is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

The law builds on FDA’s ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA’s decision-making process. Cures enhance our ability to modernize clinical trial designs and clinical outcome assessments, which will speed the development and review of novel medical products, including medical countermeasures.

It also provides new authority to help FDA improve our ability to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs.

More specifically, Cures is boosting four major innovative initiatives at the NIH: the Beau Biden Cancer Moonshot, which works to accelerate progress in cancer prevention and screening; the Precision Medicine Initiative, which is a long-term research endeavor aimed at understanding how a person’s genetics, environment and lifestyle can help determine the best approach to prevent or treat disease; the Brain Research through Advancing Innovative Neurotechnologies Initiative, which supports a more dynamic understanding of brain functions; and the Regenerative Medicine Innovation Project, which aims to accelerate the field of stem cell science.

Here are a list of the 21st Century Cures Act Deliverables and here is the entire 21st Century Cures Act (Congress.gov).

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