Pandemic Effect: Sponsors Paid Far Fewer User Fees Than Expected In FY 2020
Executive Summary
Revenue increases are expected in FY 2021 over pre-pandemic estimates, in part because the US FDA believes sponsors may have applications that were delayed by COVID-19.
You may also be interested in...
GDUFA Collections Fell Short In FY 2021
The US FDA reports that GDUFA met all of its 11 performance enhancement goals in FY 2021, while BsUFA is on track to meet 16 of 27 of its performance enhancement goals.
PDUFA Collections Exceeded Target In FY 2021, While GDUFA Fell Short
The US FDA reports that the prescription drug user fee program met 27 of its 29 commitments by the end of FY 2021 and the biosimilar user fee program is on track to meet 16 of 27 of its performance enhancement goals.
Curious Biosimilar Issues: More Workload, But Fewer US FDA Staff Needed
The US FDA’s capacity planning formula indicates a smaller biosimilar program than a year ago, but says supplement, meeting and other work continue to increase.