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Over the past year and as a result of the COVID-19 pandemic, FDA relied on alternative inspectional tools and approaches, including remote interactive evaluations and record requests, as well as a prioritization scheme, to continue its oversight activities.
According to a
recently released FDA report, while FDA conducted 218 mission critical and prioritized inspections of human drug and biologic facilities, the agency also made broad use of alternative inspection strategies. By example, FDA issued over 1,300 record requests to human and animal drug and biologic manufacturers. However, even with utilization of alternative mechanisms, the pandemic did take a toll on product approvals. FDA reports that there are 49 human drug and biologic applications for which approval is delayed due to pending inspections. There are also 87 remaining drug and biologic facility follow-up inspections that are needed to resolve prior “official action indicated” findings. This is not to mention numerous surveillance inspections that did not take place.