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, say FDA officials..
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GMP warnings to firms making supplement firms marketed in US have been rare since FDA temporarily suspended on-site inspections with onset of COVID-19 pandemic. But GMP problems surfaced after agency resumed inspections last July.
Agency is considering posting its observations from remote assessments of facilities, assistant commissioner Miller tells annual FDLI meeting; new FDA Inspectional Activities Council will develop an action plan for the agency’s inspections program.
Guidance discusses what are generically called virtual inspections, but which the agency terms “remote interactive evaluations.” As site inspections remain constrained by the pandemic, remote interactive evaluations “should help FDA operate within normal timeframes,” the document says.