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In its Complete Response Letter on Tuesday, the FDA indicated that it was continuing to review safety data for Ocaliva from one of its confirmatory studies

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Mislabeling, repurposing or unauthorized use violates regulatory requirements and can result in serious legal consequences for the institution

[DOI] [PubMed] [Google Scholar] 130.Porreca F., Tang Q.B., Bian D., Riedl M., Elde R., Lai J