US FDA’s Remote Assessments Pose Risks For Drug Manufacturers
Information shared through a remote interactive evaluation or records request could create 'fact traps' for companies during subsequent discussions with the agency, and there’s a chance the data could be misunderstood; also, it remains to be seen if findings from remote evaluations could support civil or criminal proceedings, lawyers and consultants tell a FDLI conference.
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Agency provides new details on plans for various remote methods of assessing manufacturing establishments that became popular when investigators were prevented by COVID-19 pandemic travel restrictions from visiting sites in person.
The use of various acronyms – including RRA, RIE and RRR – to describe remote assessments of sites and study data has been confusing and makes it sound as though people are speaking ‘like a pirate,’ Office of Study Integrity and Surveillance director Sean Kassim says.
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.