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US FDA’s Inspection Volume Projected To Return To Normal Levels In FY 2022 As Backlog Looms

 
• By Derrick Gingery

Additional hiring in FDA’s FY 2022 budget request also is expected to help address the inspections delayed by the coronavirus pandemic.

Budget increasing
The FDA requested a 7.9% increase in its overall budget, including a 9.8% increase in budget authority. • Source: Alamy

The US Food and Drug Administration’s drug manufacturing facility inspections are expected to dramatically increase in fiscal year 2022 to more normal levels, but additional funding may be necessary to combat the backlog caused by the coronavirus pandemic.

COVID-related restrictions nearly ground the entire inspection program to a halt in the second half of FY 2020 and most of FY 2021. The agency conducted 1,398 human drug inspections in FY 2020, a drop from 2,834 the previous year. Only 190 inspections are expected in FY 2021, according to the agency’s

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