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Update to Drugs, Devices, and the FDA: How Recent Legislative Changes Have Impacted Approval of New Therapies
Two major legislative actions since 2015, the 21st Century Cures Act of 2016 and the U.S. Food and Drug Administration (FDA) Reauthorization Act of 2017, contain significant provisions that potentially streamline drug development times, and by extension, may reduce costs. Evidence suggests, however,...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Elsevier
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444905/ https://www.ncbi.nlm.nih.gov/pubmed/32864509 http://dx.doi.org/10.1016/j.jacbts.2020.06.010 |