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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GDUFA Research Impacting Generic Development, ANDA Approvals
Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.
Generic Review At US FDA: Record Month Completes Approval Volume Recovery
With 96 full ANDA approvals and 30 tentative approvals, July was the most productive month since GDUFA launched.
Generics Office At US FDA Could Get New Director Before Uhl Departs
Kathleen Uhl gave seven months' notice of her retirement, which may allow new director to be hired and on-boarded before she departs.