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A company, physician, pharmacist, or organization could submit a new or amended nomination with stronger evidence, such as better-controlled human trials, more complete safety data, clearer dosing, route-specific evidence, better manufacturing specifications, precise chemical identification, stability data, impurity testing, and evidence of a clinical need not met by approved medicines

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[DOI] [PubMed] [Google Scholar] 100.Sun B, Luo C, Zhang X, Guo M, Sun M, Yu H, et al