FDA Obscura: GDUFA Fee Calculations Took CBER-Regulated ANDAs Into Account
ANDAs regulated by the US FDA's biologics center, some pre-1984 conditional approvals, and others were factored into GDUFA program fee calculations.
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Increases in the number of expected ANDA submissions, facilities and entities holding approved applications means lower user fees in most GDUFA II categories starting 1 October; program fee will see the largest percentage drop, amounting to savings of $200,000 for large companies.
Industry consolidation may be a reason ANDA withdrawals have increased during GDUFA II.
FDA decided against trying to predict upcoming approvals as part of FY 2019 GDUFA program fee calculations, but other adjustments likely increased fee significantly.