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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Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.
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US FDA draft guidance says substantive changes to reference product may require major ANDA amendment and 10-month review goal for the generic.