US FDA's Generics Program Reaches 'Steady State' Milestone
OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.
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Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.
With 96 full ANDA approvals and 30 tentative approvals, July was the most productive month since GDUFA launched.
Kathleen Uhl gave seven months' notice of her retirement, which may allow new director to be hired and on-boarded before she departs.