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[70] [71] Wool was a valuable product that did not spoil when transported long distances

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

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This is due to successful lobbying, concern that FDA regulation would be taken as approval, a lack of FDA funding, and a 2000 Supreme Court ruling holding that the FDA lacks jurisdiction over tobacco