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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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New Generics Team Will Improve Review Efficiency, Consistency

With formal review goals weeks away, the Office of Generic Drugs creates a Quality Oversight Team that will help increase and improve application review capacity.

FDA Generics Office Finalizing Structure As Review Goals Approach

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.

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