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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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Dettagli Bibliografici
Pubblicato in:Drug Discov Today
Autori principali: Rizk, John G., Forthal, Donald N., Kalantar-Zadeh, Kamyar, Mehra, Mandeep R., Lavie, Carl J., Rizk, Youssef, Pfeiffer, JoAnn P., Lewin, John C.
Natura: Artigo
Lingua:Inglês
Pubblicazione: Elsevier Ltd. 2021
Soggetti:
Accesso online: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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