Scenes From A Shutdown: US FDA Hides It Well
FDA's two recent advisory committee meetings at its White Oak campus offer no obvious clues that agency is struggling due to dwindling carryover balances and furloughed employees.
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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.
Compounding carryover money runs out, crippling some activities although inspections will continue; countdown to the end of PDUFA fee balance continues.
Some Endocrinologic and Metabolic Drugs Advisory Committee members said a REMS is sufficient, but others worried that proposed risk management plans were not proven effective.