FDA Hopes to Resume On-Site Inspections by September

May 7, 2021

The FDA said that it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September.

In a new report, the agency outlined projections on how it could return to a more normal schedule of inspections based on three pandemic scenarios — most likely, best case and worst case.

Under the most-likely scenario, the agency estimates that it can take care of 851 (26 percent) of the 3,229 human and animal medical product domestic inspections scheduled but not yet completed in the rest of fiscal 2021.

In the worst-case scenario, where new variants emerge and/or new pandemic-related challenges occur, the agency said it would continue to rely more heavily on alternative oversight tools, which it has used extensively to conduct oversight of drugmakers during the pandemic.

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