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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Detalhes bibliográficos
Publicado no:JAMA Netw Open
Main Authors: Zhang, Audrey D., Puthumana, Jeremy, Downing, Nicholas S., Shah, Nilay D., Krumholz, Harlan M., Ross, Joseph S.
Formato: Artigo
Idioma:Inglês
Publicado em: American Medical Association 2020
Assuntos:
Original Investigation
Acesso em linha: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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