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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Autors principals: Feigal, Ellen G., Tsokas, Katherine, Zhang, Jiwen, Cromer, Marc V., Whittlesey, Kevin J., Werner, Michael J.
Format: Artigo
Idioma:Inglês
Publicat: AlphaMed Press 2012
Matèries:
Standards, Policies, Protocols, and Regulations for Cell-Based Therapies
Accés en línia: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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