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Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic.

The US Food and Drug Administration (FDA) Expanded Access (EA) Program, which allows for compassionate uses of unapproved therapeutics and diagnostics outside of clinical trials, has gained significant traction during the Coronavirus 2019 (COVID-19) pandemic. While development of vaccines has been t...

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Detalles Bibliográficos
Autores principales: Rizk, John G., Forthal, Donald N., Kalantar-Zadeh, Kamyar, Mehra, Mandeep R., Lavie, Carl J., Rizk, Youssef, Pfeiffer, JoAnn P., Lewin, John C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Ltd. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7694556/
https://www.ncbi.nlm.nih.gov/pubmed/33253920
http://dx.doi.org/10.1016/j.drudis.2020.11.025