Sovaldi NDA Review Marred By Manufacturing Compliance Issues
This article was originally published in Pharmaceutical Approvals Monthly
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 Good Manufacturing Practice violations and data integrity concerns.
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Review Of Reviews: Drug Review Profiles 2014
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2014.
Review Of Reviews: Drug Review Profiles 2014
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2014.