FDA’s FY 2020 PDUFA Fees Rise to Nearly $3 Million for Applications Needing Clinical Data

The FDA has released its FY 2020 prescription drug user fees — and sponsors will have to pay considerably more for them starting October 1.

Fiscal 2020’s prescription drug user fees have gone up almost 14 percent. New drug and biologics license applications requiring clinical data will cost $2,942,965, while applications that need no clinical data will cost $1,471,483. The agency’s annual program fees have been assessed at $325,424.

The FDA said it will send out invoices and payment instructions for FY 2020 program fees this month.