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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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Top Stories of 2014

Readers of “The Gold Sheet” focused more on articles about data integrity than any other topic last year, which is a big reason why data integrity was the No. 1 story of 2014. A number of other highly read articles last year focused on additional topics that were also among the top stories in pharmaceutical manufacturing quality last year.

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Agency reviewers were skeptical about awarding Gilead’s sofosbuvir an indication for use in combination with other, unspecified agents for treating chronic hepatitis C – a game-changing approach for the fast-evolving field. However, data submitted late in the review process from two ongoing Phase III studies convinced FDA that a broad indication was justified.

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