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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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.
Performance numbers are likely to fluctuate over the course of the program, but the rate of first-cycle approvals during the first month of the new user fee program is more than double the rate during the last year of the old iteration.