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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Dettagli Bibliografici
Pubblicato in:JAMA Netw Open
Autori principali: Zhang, Audrey D., Puthumana, Jeremy, Downing, Nicholas S., Shah, Nilay D., Krumholz, Harlan M., Ross, Joseph S.
Natura: Artigo
Lingua:Inglês
Pubblicazione: American Medical Association 2020
Soggetti:
Original Investigation
Accesso online: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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