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Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19
Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency,...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
SAGE Publications
2020
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756060/ https://www.ncbi.nlm.nih.gov/pubmed/33349145 http://dx.doi.org/10.1177/0020731420979824 |