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What it does is initiate a formal rulemaking process under the Federal Food, Drug, and Cosmetic Act in which the FDA must publish a proposed rule, accept public comment typically for 60 to 90 days and issue a final determination
Nobody can give you an honest probability of harm because the studies that would generate one have not been done
Involvement of research-subject glutathione S-transferase isoenzymes in the conjugation of cyclophosphamide metabolites with glutathione
Sourcing is the line we will not cross
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