US FDA Shuttering More Operations As User Fee Money Dwindles
Compounding carryover money runs out, crippling some activities although inspections will continue; countdown to the end of PDUFA fee balance continues.
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Nearly 70% of the FDA workforce would be retained, most from carryover user fee dollars, but potential morale problems loom if government funding runs out again.
Employees are no doubt are excited to resume work and may have a dozen or more major NDAs pending, but agency morale may not recover quickly.
More than 300 generic drug applications might be officially filed when the shutdown ends, substantially increasing stress on assessors and other Office of Generic Drugs staff.