ICMRA Review Finds Remote Alternatives Could Complement Onsite Inspections, Not Replace Them
Stance echoes US FDA’s view that remote alternatives should be “supplemental tools” to support in-person inspections.
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Agency hints of a “hybrid” future of in-person inspections supplemented by alternative tools like remote interactive evaluations.
US, EU, global authorities share experiences, insights, advice for industry on remote alternatives even after inspectors can resume travels.
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.