Among other things, the report highlights:
- From March 2020 through March 2021, the FDA conducted a total of 821 mission-critical inspections, including 29 in foreign countries.
- Additionally, the agency conducted a total of 777 prioritized domestic inspections since resumption of that work in July 2020.
- Of the more than 13,500 applications for medical product approval or authorization received since March 2020, an estimated 68 applications have been delayed due to the inability to conduct inspections — and a majority of those are not deemed mission critical.
Additionally, the report outlines the FDA's continued successful use of alternative tools and approaches where inspections were or are not currently feasible, including remote interactive evaluations (e.g., remote livestreaming video of operations, teleconferences or screen sharing), record requests and leveraging information from trusted regulatory partners. For example, over 1,300 record requests have been made to human and animal drug and biologic drug manufacturers that have led to a high level of on-time regulatory decision actions.
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