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Once the FDA has approved an NDA/BLA, the drug may enter the US market, but the FDA continues to address and monitor many key areas drug production, distribution, labeling, safety, direct to consumer advertising, use, and risk management

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In a phase III randomized controlled trial, 966 patients with mild-to-moderate MASH (stage F1b, F2 or F3) were randomly assigned to once-daily oral treatment with 80 mg or 100 mg resmetirom or placebo for 52 weeks 4

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