US FDA’s Remote Evaluations Of Drug Manufacturing Facilities May Become Public
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.
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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.