Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017

IMPORTANCE: Since the introduction of the Fast Track designation in 1988, the number of special regulatory programs available for the approval of new drugs and biologics by the US Food and Drug Administration (FDA) has increased, offering the agency flexibility with respect to evidentiary requiremen...

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Publicado en:JAMA Netw Open
Autores principales: Zhang, Audrey D., Puthumana, Jeremy, Downing, Nicholas S., Shah, Nilay D., Krumholz, Harlan M., Ross, Joseph S.
Formato: Artigo
Lenguaje:Inglês
Publicado: American Medical Association 2020
Materias:
Original Investigation
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC7175081/
https://ncbi.nlm.nih.gov/pubmed/32315070
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamanetworkopen.2020.3284
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