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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

Glutathione (GSH) is a tripeptide that contains an unusual peptide linkage between the amine group of cysteine (which is attached by normal peptide linkage to a glycine) and the carboxyl group of the glutamate side-chain.It is an antioxidant, preventing damage to important cellular components caused by reactive oxygen species such as free radicals and peroxides

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doi: 10.1161/jaha.117.005819 258 VenkateshappaC.HarishG.MahadevanA.Srinivas BharathM