As US FDA Shutdown Continues, What Will Be The Cost Of Not Spending?
Bolus of applications could be filed once government reopens, but employee morale and recruitment efforts could suffer drop-off.
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Compounding carryover money runs out, crippling some activities although inspections will continue; countdown to the end of PDUFA fee balance continues.
ANDA and NDA/BLA supplement approvals continue thanks to carryover user fee funds, but US FDA hasn't made any NDA and BLA approvals during shutdown as as anxiety over effect of "lapse period" on agency increases.
US FDA has enough carryover funding for another month of operations, Commissioner Gottlieb says, potentially endangering late February and March review goals.