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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Bibliographic Details
Main Authors: Feigal, Ellen G., Tsokas, Katherine, Zhang, Jiwen, Cromer, Marc V., Whittlesey, Kevin J., Werner, Michael J.
Format: Artigo
Language:Inglês
Published: AlphaMed Press 2012
Subjects:
Standards, Policies, Protocols, and Regulations for Cell-Based Therapies
Online Access: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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