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Pharmaceuticals / Regulatory Affairs

FDA Explains How It’s Handling Drug Applications Submitted During Shutdown

Feb. 6, 2019

The FDA clarified how the agency is dealing with drug applications submitted during the 35-day partial government shutdown.

Any fiscal 2019 fees submitted during the lapse period were held until Jan. 28, the first business day after the shutdown, the agency said.

For ANDAs submitted during the shutdown, sponsors have until Feb. 18 to pay the fee. For NDAs and BLAs submitted during the funding lapse, sponsors had until Feb. 1 to pay fees. In either case, if the fee is satisfied within the window, the official receipt date will be Jan. 28.

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