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The purpose of the NDA is to provide FDA reviewers with enough information to make the following key decisions: Comprehending whether the drug is safe and effective in its proposed use(s) Comprehending whether the benefits of the drug outweigh the risks Determining whether the drug's submitted labeling (package insert) is appropriate, and what it should include Determining whether the methods used in manufacturing the drug and the controls used to maintain its quality are sufficient to maintain the drug's identity, strength, quality, and purity

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To understand the complexities of this disease, you must respect those failures

Recent studies have highlighted key molecular targets such as SREBP (Yue et al., 2021), AMPK (Lu et al., 2016), NF-B (Ren et al., 2020) as mechanisms by which Chinese botanical drugs regulate lipid metabolism in the liver