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Farsalinos, for his part, has now expanded on his initial hypothesis with a peer-reviewed paper in the journal Toxicology Reports
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And of course, the onus is on the applicants to ensure that they are providing the most robust signs possible to inform decision-making. The FDA has long been criticized for its handling of the premarket tobacco product application (PMTA) process and is currently defending multiple lawsuits from vapor companies challenging its marketing denial orders (MDOs), including two from Juul Labs, which recently filed a lawsuit over the regulatory agencys refusal to disclose documents supporting its MDO
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