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