Shutdown Week Three: Sponsors With Upcoming User Fee Dates Should Start Sweating
US FDA has enough carryover funding for another month of operations, Commissioner Gottlieb says, potentially endangering late February and March review goals.
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Sponsors have been asked to switch to teleconferences with FDA staff as the agency prepares for more of its employees to work from home.
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.
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.