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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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.
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.
No more letters derailing applications over surprise drug GMP issues raised in remote records reviews, agency says. Now if sponsors get these CRLs, they will already know why.