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,...

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Detalles Bibliográficos
Autores principales: Lexchin, Joel, Graham, Janice, Herder, Matthew, Jefferson, Tom, Lemmens, Trudo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2020
Materias:
I. How are the COVID-19 Vaccines Being Approved? An International Review
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

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756060/
https://www.ncbi.nlm.nih.gov/pubmed/33349145
http://dx.doi.org/10.1177/0020731420979824

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