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Sovaldi NDA Review Marred By Manufacturing Compliance Issues

This article was originally published in The Gold Sheet

Executive Summary

Faced with the prospects of FDA non-approval of its priority review hepatitis C drug sofosbuvir, Gilead withdrew a foreign API manufacturer and one of its own testing facilities from the NDA late in the review process due to GMP violations and data integrity concerns. This case study shows how manufacturing problems can threaten to derail an otherwise stellar application with strong efficacy and safety data.


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