US FDA Appears To Have Avoided Shutdown-Related ANDA Bolus
Generic submissions were below historical norms in December and modestly higher January, meaning shutdown likely did not create a large pile of pending work.
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Commissioner Gottlieb tells Congress that FDA won’t meet all its planned goals for inspections after month-long partial government shutdown, but he does not expect a noticeable impact on product reviews. The longer term impact will depend on morale: hiring and retention are key focus.
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.
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.