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.
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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.
Good Clinical Practice Inspections Take On Narrower Focus During Pandemic, US FDA Says
Technological and logistical challenges have forced agency staff to triage document and interview requests to focus on the most important issues when conducting remote regulatory assessments and in-person inspections, an FDA official told a conference of international regulators.
US FDA Bioresearch Monitoring Program’s Reliance On Remote Assessment Tools Grows
Remote regulatory assessments for drug bioavailability/bioequivalence studies rose 71% in FY2021 while the number of on-site inspections in this category fell by 88%; pandemic continues to drive a decline in clinical investigator inspections across FDA's BIMO program.