US FDA Explains Why Remote Interactive Evaluations Guidance Took So Long

Time taken for interagency alignment, lessons learned from foreign counterparts will increase use of remote video tours, FDA officials tell the Pink Sheet.

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the fda has been perfecting its 'virtual inspections' guidance

The extra time the US Food and Drug Administration took to produce guidance on live remote video plant tours reflects the agency’s enthusiasm for them, not a reluctance to supplement inspections with them during the pandemic, agency officials told the Pink Sheet.

The FDA produced a blizzard of COVID-19-related guidance documents in the spring and summer of 2020, including some that were related to inspections. But guidance on live remote inspection alternatives...

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