FDA Generics Office Hopes To Clear Unmeasured ANDAs
This article was originally published in PharmAsia News
Executive Summary
The U.S. FDA’s Office of Generic Drugs restructures again and adds specialist who helped relieve supplement backlog to improve ANDA review process.
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Transition team leaders gain acting director titles, but “long and arduous” reorganization is not yet complete, CDER Director Woodcock notes.
FDA Product Quality Reviews Could Become Team Effort To Improve Consistency
CDER Director Janet Woodcock says when an NDA nears patent expiry and generics are preparing for market entry, reviewers would hand it off to a life-cycle team that would also handle associated ANDAs.