Evaluating integration in collaborative cross-disciplinary FDA new drug reviews using an input-process-output model

BACKGROUND/OBJECTIVES: The US Food and Drug Administration (FDA) is responsible for assessing safety (risks) and effectiveness (benefits) of new drug products using the data provided in a Sponsor’s new drug product marketing application before they can be marketed. The FDA forms cross-disciplinary r...

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Detalles Bibliográficos
Autores principales: Bugin, Kevin, Lotrecchiano, Gaetano R., O’Rourke, Michael, Butler, Joan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2021
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8727715/
https://www.ncbi.nlm.nih.gov/pubmed/35047211
http://dx.doi.org/10.1017/cts.2021.861

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8727715/
https://www.ncbi.nlm.nih.gov/pubmed/35047211
http://dx.doi.org/10.1017/cts.2021.861

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