Expanding Patient Access to Investigational New Drugs: Overview of Intermediate and Widespread Treatment Investigational New Drugs, and Emergency Authorization in Public Health Emergencies

Individual patients with life-threatening or severely debilitating diseases can petition the U.S. Food and Drug Administration (FDA) through their physicians to have expanded access (EA) to drugs that are in clinical trials but have not reached full FDA approval (the “single-patient” investigational...

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Detalles Bibliográficos
Autor principal: Van Norman, Gail A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2018
Materias:
TRANSLATIONAL TOOLBOX
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6058931/
https://www.ncbi.nlm.nih.gov/pubmed/30062226
http://dx.doi.org/10.1016/j.jacbts.2018.02.001

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6058931/
https://www.ncbi.nlm.nih.gov/pubmed/30062226
http://dx.doi.org/10.1016/j.jacbts.2018.02.001

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