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They are not approved by the FDA or any other regulatory body for human or animal use, consumption, or therapeutic application

[DOI] [PMC free article] [PubMed] [Google Scholar] 143.Rybka J., Kupczyk D., Kedziora-Kornatowska K., Motyl J., Czuczejko J., Szewczyk-Golec K., Kozakiewicz M., Pawluk H., Carvalho L.A., Kedziora J

Differences in kinetic characteristics and in sensitivity to inhibitors between human and rat liver alcohol dehydrogenase and aldehyde dehydrogenase

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Although we elected to address the issues in proposed 424.527 via rulemaking, we noted in the proposed rule that we retained the authority under section 1866(j)(3)(B) of the Act to establish and implement PPEO procedures via sub-regulatory guidance
