The Use of External Controls in FDA Regulatory Decision Making

The regulatory standards of the United States Food and Drug Administration (FDA) require substantial evidence of effectiveness from adequate and well-controlled trials that typically use a valid comparison to an internal concurrent control. However, when it is not feasible or ethical to use an inter...

Descripción completa

Detalles Bibliográficos
Autores principales: Jahanshahi, Mahta, Gregg, Keith, Davis, Gillian, Ndu, Adora, Miller, Veronica, Vockley, Jerry, Ollivier, Cecile, Franolic, Tanja, Sakai, Sharon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8332598/
https://www.ncbi.nlm.nih.gov/pubmed/34014439
http://dx.doi.org/10.1007/s43441-021-00302-y

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8332598/
https://www.ncbi.nlm.nih.gov/pubmed/34014439
http://dx.doi.org/10.1007/s43441-021-00302-y

Ejemplares similares