Shutdown Week Four: FDA Maintains Pre-Shutdown Output Pace In Some Cases
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.
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Generic submissions were below historical norms in December and modestly higher January, meaning shutdown likely did not create a large pile of pending work.
US FDA draft guidance says substantive changes to reference product may require major ANDA amendment and 10-month review goal for the generic.
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.