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Drugs and Devices: Comparison of European and U.S. Approval Processes
The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible. The United States and the European Union approach these challenges in...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Elsevier
2016
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6113412/ https://www.ncbi.nlm.nih.gov/pubmed/30167527 http://dx.doi.org/10.1016/j.jacbts.2016.06.003 |