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Regulatory Implications of Neoplastic Cell Substrate Tumorigenicity

Regulatory Implications of Neoplastic Cell Substrate Tumorigenicity. Andrew M. Lewis Jr. M.D. DVP, OVRR, CBER, FDA. Outline. Review regulatory concerns - define tumorigenicity Review tumorigenicity testing: 1. How tumorigenicity is evaluated

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Regulatory Implications of Neoplastic Cell Substrate Tumorigenicity