US FDA's 'Great' Generic Approval Engine Can Be Better, New OGD Director Says
Executive Summary
In interview with the Pink Sheet, Sally Choe expresses doubts that setting goals for approval totals is productive, saying the current workflow looks fine.
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US FDA’s New Generics Chief: We Need More Flexibility For Complex Products
Iilun Murphy said Hatch-Waxman was written with immediate-release oral drugs in mind, not the complex generics becoming more popular today. The agency is evaluating the issue.
FDA Seeks New Generics Chief As Choe Moves On
The US Food and Drug Administration has begun searching for a new director for its Office of Generic Drugs, after announcing that Sally Choe will leave the agency in early October.