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Conduct site-directed mutant phenotype analyses of elbasvir against HCV replicons carrying the following NS5A substitutions K24R GT1a H54Y GT4d E62D GT1a D427N GT1a. Fda.gov/AboutFDA/CentersOffices/CDER/ucm090142. htm. REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA 21 CFR 314. This new drug application provides for the use of Zepatier elbasvir/grazoprevir tablet with or adults. Section 506B of the FDCA as well as 21 CFR 314. 81 b 2...
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