Perspective: Communications with the Food and Drug Administration on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?

Effective interaction between key stakeholders and the U.S. Food and Drug Administration (FDA) is central to successfully navigating the regulatory process and advancing new therapies into clinical trials. This is especially true when developing cell-based therapies, which pose unique challenges to...

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Detalhes bibliográficos
Main Authors: Feigal, Ellen G., Tsokas, Katherine, Zhang, Jiwen, Cromer, Marc V., Whittlesey, Kevin J., Werner, Michael J.
Formato: Artigo
Idioma:Inglês
Publicado em: AlphaMed Press 2012
Assuntos:
Standards, Policies, Protocols, and Regulations for Cell-Based Therapies
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3659665/
https://ncbi.nlm.nih.gov/pubmed/23197694
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.5966/sctm.2012-0104
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