Thursday, October 22, 2020 10:40:14 AM
From this article published today.
https://www.parexel.com/news-events-resources/blog/early-demise-fda-exaggerated-highlights-fdli-annual-meeting
The agency is using its statutory authorities under Section 704 of the FDCA (Section 706 of FDASIA) requesting information in advance of inspections to prioritize and triage the backlog of manufacturing inspections for drugs. So far, FDA has conducted approximately 200 mission critical inspections during the pandemic.
There is a process underway to examine the utility of remote or “virtual” inspections and work is being done to create work procedures for remote inspections.
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