US Generics Approvals Will Decline
But FDA Predicts Supplement Work May Grow
With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.
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Amid questions about generic industry market dynamics, the user fee renewal could focus on limiting increases in US FDA collections.
CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.
While FDA is on pace to again break its record for full ANDA approvals in FY 2019, the first-cycle approval rate is dropping, as illustrated in our charts.