An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations

BACKGROUND: Limited research has been conducted to examine whether clinical investigators (CIs), sponsors (SPs), contract research organizations (CROs), and sponsor-investigators (SIs) continue conducting clinical trials following issuance of FDA Official Action Indicated (OAI) letters. FDA issues O...

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Detalles Bibliográficos
Autores principales: Jung, Miah, Swann, Rachelle M., Anantha, Michelle S., Jamali, Faranak
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8332576/
https://www.ncbi.nlm.nih.gov/pubmed/34101151
http://dx.doi.org/10.1007/s43441-021-00267-y

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8332576/
https://www.ncbi.nlm.nih.gov/pubmed/34101151
http://dx.doi.org/10.1007/s43441-021-00267-y

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