US FDA Generic Drug Applications Will Cost Less In FY 2020
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.
You may also be interested in...
The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.
ANDAs regulated by the US FDA's biologics center, some pre-1984 conditional approvals, and others were factored into GDUFA program fee calculations.
The US FDA fee for a new drug or biologics license application requiring clinical data will jump to $2.94m in October.