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By contrast, even at the maximum dose levels tested, neither the TPM nor GVP from any of the aerosols of all the new products or ENDS market comparisons was mutagenic, cytotoxic, or genotoxic under the test conditions. ( 3.3 Example reiterating the importance of involving the regulatory agency early in the experimental development process and to clearly describe the NAMs In the decision summary of a PMTA where five separate in vitro organotypic studies were submitted, it was noted The experimental approach taken in these studies included using methods that are exploratory, have not been independently validated, and have unknown utility for regulatory use