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Medeva Hepagene

Executive Summary

FDA issues a refuse-to-file letter for the trivalent recombinant hepatitis B vaccine BLA submitted Feb. 10. The letter, issued the week of April 5, questions whether the number of subjects in the clinical database of the application is enough, Medeva said. FDA has also requested modifications to and further information on good manufacturing practices for the vaccine and information on equipment, processes and systems validation protocols as well as comparative clinical data from final manufacturing lots. Medeva plans to meet with FDA in May to address the issues

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