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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

In 2012, Stockwell and colleagues described a novel form of cell death that was elicited by inhibiting the cystine/glutamate antiporter, system X C , a transporter that feeds cells with cysteine to be used for protein and, in particular, GSH biosynthesis 5 ( Fig

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

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