GDUFA III Agreement Will Constrain Fee Revenue Increases
Executive Summary
Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.
You may also be interested in...
US FDA Exploring Furlough Possibility If User Fee Bill Not Enacted In Time
Furloughs would allow affected FDA staff to remain employed, while a layoffs would require affected workers to be rehired.
US FDA Exploring Furlough Possibility If User Fee Bill Not Enacted In Time
Furloughs would allow affected FDA staff to remain employed, while a layoffs would require affected workers to be rehired.
MDUFA V: US FDA Staff Could See September Lay-Off Notices
The notices normally would go out on 1 August, but unspent user fee funds may be able to sustain work for a few weeks if the program expires.