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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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Detalhes bibliográficos
Publicado no:Drug Discov Today
Main Authors: Rizk, John G., Forthal, Donald N., Kalantar-Zadeh, Kamyar, Mehra, Mandeep R., Lavie, Carl J., Rizk, Youssef, Pfeiffer, JoAnn P., Lewin, John C.
Formato: Artigo
Idioma:Inglês
Publicado em: Elsevier Ltd. 2021
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Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7694556/
https://ncbi.nlm.nih.gov/pubmed/33253920
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.drudis.2020.11.025
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