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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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.
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.