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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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.
FDA Generic Approvals Peak In April
The April total is the highest monthly total in seven months, but only a few are first generics. Approval volume might continue rising if FDA does not find too many applications requiring in-person inspections, which were largely postponed as part of coronavirus containment measures, Robert Pollock, senior advisor and outside director to the board at Lachman Consultants, said.
GDUFA III: How Much Of A Fee Increase Can Industry Stomach?
Amid questions about generic industry market dynamics, the user fee renewal could focus on limiting increases in US FDA collections.