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Rounding Up And Down: Assessing FDA FY 2019 and FY 2020 Workload Estimates

 
• By Derrick Gingery

US FDA provides a few hints about upcoming industry application filing volume and the agency's assessment pace in FY 2020 budget documents.

FDA entrance sign 2016
US FDA says estimates indicating that ANDA receipts would drop in FY 2019 compared to the previous year were not the actual agency expectation.

The US FDA is not expecting a decrease in ANDA receipts in fiscal years 2019 and 2020, even though its budget request suggests that a drop will happen.

The agency wrote in its FY 2020 budget request congressional justification that after receiving 1,044 ANDAs in FY 2018, the agency expected to receive only 1,000 in FY 2019...

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