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...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Hauptverfasser: Feigal, Ellen G., Tsokas, Katherine, Zhang, Jiwen, Cromer, Marc V., Whittlesey, Kevin J., Werner, Michael J.
Format: Artigo
Sprache:Inglês
Veröffentlicht: AlphaMed Press 2012
Schlagworte:
Standards, Policies, Protocols, and Regulations for Cell-Based Therapies
Online Zugang: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
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!

Ähnliche Einträge