Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency

BACKGROUND: The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for GCP oversight. No systematic assessments of GCP...

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Detalles Bibliográficos
Autores principales: Sellers, Jenn W., Mihaescu, Camelia M., Ayalew, Kassa, Kronstein, Phillip D., Yu, Bei, Ning, Yang-Min, Rodriguez, Miguel, Williams, LaKisha, Khin, Ni A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9356921/
https://www.ncbi.nlm.nih.gov/pubmed/35610469
http://dx.doi.org/10.1007/s43441-022-00417-w

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