GDUFA Collections Fell Short In FY 2021
Biosimilars Came Closer While PDUFA Collections Exceeded Target
Executive Summary
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.
You may also be interested in...
User Fee Bill Clears Senate Committee With Importation, Orphan Drug Amendments
Highlighting the much-less-bipartisan atmosphere than the House, ranking member Burr votes against the package; US FDA’s advice to generic applicants could be contentious issue in reconciling the legislation between the two chambers.
Continuous Pharmaceutical Manufacturing Bill Hitches A Ride With US FDA User Fee Legislation
US legislation could advance new manufacturing platforms for drugs and biologics with academic R&D and workforce development and in turn spur domestic growth.
House User Fee Mark-Up: Few Tweaks, But Concerns About ALS And Accelerated Approval
Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.