Communications with the Food and Drug Administration on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How? (October 17, 2012, Stem Cells Translational Medicine)
October 17, 2012 - (Stem Cells Translational Medicine) - This article provides an overview of the types of interactions with the FDA that are available throughout the regulatory process. This article also notes some common pitfalls to avoid and directs readers to additional references and resources to help inform cell therapy researchers and product developers and enable successful regulatory interactions. Read Full Article
