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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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Detalhes bibliográficos
Publicado no:JACC Basic Transl Sci
Autor principal: Van Norman, Gail A.
Formato: Artigo
Idioma:Inglês
Publicado em: Elsevier 2020
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7444905/
https://ncbi.nlm.nih.gov/pubmed/32864509
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.jacbts.2020.06.010
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