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352) of the general controls of the act would warn dentists about the rare risk of allergic reactions among patients and the risk of toxicity to dental health professionals. Arriving at its conclusion that the risk of allergic reaction was rare, the FDA relied on three (3) case reports, ignoring several other scientific studies clearly within the criteria set out in 21 C.F.R

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These models encompass diverse etiologies including genetic, chromosomal, i.e., copy number variations (CNVs), and environmental insults 21

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