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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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Clin Chim Acta 216:5361 Okun JG, Kolker S, Schulze A, Kohlmuller D, Olgemoller K, Lindner M, Hoffmann GF, Wanders RJ, Mayatepek E (2002) A method for quantitative acylcarnitine profiling in human skin fibroblasts using unlabelled palmitic acid: diagnosis of fatty acid oxidation disorders and differentiation between biochemical phenotypes of MCAD deficiency

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What to Expect From a Medically Supervised Weight Loss Program Most GLP-1 programs start with a low dose that increases gradually over several weeks