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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

Journal of Neuroimmunology 317, 3744

Mixing an approved drug with an investigational compound is the standard safety position

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Upregulated PKM2 in macrophages exacerbates experimental arthritis via STAT1 signaling