FDA's Post-Shutdown ANDA Bolus Could Be Massive
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.
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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US FDA draft guidance says substantive changes to reference product may require major ANDA amendment and 10-month review goal for the generic.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.