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Association of expedited review programmes with postmarketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017

OBJECTIVE: To explore the associations between the risks of postmarketing safety events of new drugs and the four expedited programmes of priority review, accelerated approval, fast track and breakthrough therapy established by the US Food and Drug Administration (FDA); and to investigate whether mu...

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Detalles Bibliográficos
Autores principales: Zhu, Xingyue, Liu, Bao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9301790/
http://dx.doi.org/10.1136/bmjopen-2021-058843