Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency

BACKGROUND: The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) began collaboration on Good Clinical Practice (GCP) inspections for marketing applications since 2009. The main characteristics of the GCP inspection processes between FDA and EMA were never evaluated. This i...

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Detalles Bibliográficos
Autores principales: Ayalew, Kassa, Ning, Yang-Min, Foringer, Michelle J., Leibenhaut, Susan, Sellers, Jenn W., Yu, Bei, Kronstein, Phillip D., Higgerson, Agata, Mihaescu, Camelia, 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/PMC9755076/
https://www.ncbi.nlm.nih.gov/pubmed/35972722
http://dx.doi.org/10.1007/s43441-022-00441-w

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