The 21st Century Cures Act promises to boost the budgets of both the US National Institutes of Health (NIH) and the US Food and Drug Administration (FDA) by $1.75 billion and $110 million per year, respectively, for the next five years. This act, which the House of Representatives passed by a substantial majority in July, includes a ringing endorsement of biomedical research, creating an environment that makes it less challenging for companies to bring drugs to market. Among its many provisions, this legislation will encourage collaboration between researchers in different sectors, expedite drug and diagnostic product reviews at FDA, simplify and refocus clinical trials, including by using modern genetics to screen potential participants, and reform institutional review to rely more on centralized than on individual boards. It also seeks to provide new market incentives for companies developing treatments for rare disorders and to invest more resources in training and retaining young researchers to work on developing biomedical products. The new legislation will encourage patient groups to participate directly in the oversight process of novel treatments. Members of the Senate are developing, but are not yet near voting on, a companion bill.
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21st Century Cures Act wins in US House. Nat Biotechnol 33, 891 (2015). https://doi.org/10.1038/nbt0915-891
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DOI: https://doi.org/10.1038/nbt0915-891
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