A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA’s Benefit-Risk Framework

The US FDA Center for Biologics Evaluation and Research (CBER) is responsible for the regulation of biologically derived products. FDA has established Advisory Committees (AC) as vehicles to seek external expert advice on scientific and technical matters related to the development and evaluation of...

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Detalles Bibliográficos
Autores principales: Mutanga, Jane Namangolwa, Nukala, Ujwani, Rodriguez Messan, Marisabel, Yogurtcu, Osman N., McCormick, Quinn, Sauna, Zuben E., Whitaker, Barbee I., Forshee, Richard A., Yang, Hong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Meeting Report
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9911185/
https://www.ncbi.nlm.nih.gov/pubmed/36759415
http://dx.doi.org/10.1208/s12248-023-00789-3

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