FDA’s Generic Drug Staff To Be Reduced When Workload Under Control
This article was originally published in The Pink Sheet Daily
Some positions added as part of a hiring surge to handle generic drug user fee program responsibilities may not be refilled once vacated, FDA says.
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GDUFA funding will bring 50 additional people to the Office of Pharmaceutical Quality for generic drug review purposes.
User fees won't support dedicated staff, but rather FTEs that will work on the popular program as needed.
FDA’s Center for Drugs continues to operate under a staffing shortage at a time when it faces tremendous pressure to implement new authorities. In some cases, that’s left Janet Woodcock scrambling to find senior managers that can lead top CDER initiatives. Direct hiring authority has helped, but it doesn’t fully address FDA’s recruiting challenges. There’s still too much red tape – and not enough money.