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.
US FDA Aims To Simplify Terminology For Remote Assessments
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.
Remote Site Visits Will Help US FDA Keep Reviews On Track During Remainder Of Pandemic
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.