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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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.
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.
Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.