How US FDA's Assumptions Impacted Generic Program Fees
Executive Summary
FDA decided against trying to predict upcoming approvals as part of FY 2019 GDUFA program fee calculations, but other adjustments likely increased fee significantly.
You may also be interested in...
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.
Generics Firms Race To Withdraw ANDAs
Industry consolidation may be a reason ANDA withdrawals have increased during GDUFA II.
Generic Companies Race To Withdraw ANDAs
Industry consolidation may be a reason ANDA withdrawals have increased during GDUFA II.