5. Concluding Comments
This chapter outlined the authors’ current perspective on the complexities of general product testing requirements and design characteristics for preclinical studies involved in investigational use of cellular products for cardiac repair. The IND process is intended to balance the potential benefit of novel therapies to society with the need to generate data for prudent product development, to increase scientific knowledge, to protect subject safety, and to benefit the public health. This chapter represents an introduction to the regulation of these cellular products and investigator/sponsors are encouraged to contact FDA CBER OCTGT for more specific information on the conduct of clinical trials.
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Areman, E., Benton, K., Mcfarland, R. (2006). Regulatory Considerations in Manufacturing, Product Testing, and Preclinical Development of Cellular Products for Cardiac Repair. In: Dib, N., Taylor, D.A., Diethrich, E.B. (eds) Stem Cell Therapy and Tissue Engineering for Cardiovascular Repair. Springer, Boston, MA. https://doi.org/10.1007/0-387-30939-X_20
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