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Remote Regulatory Assessments of Bioavailability/Bioequivalence Study Conduct by the Office of Study Integrity and
Monica Javidnia1, Hasan A Irier1, Sean Kassim1
1Office of Study Integrity and Surveillance, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, United States Department of Health and Human Services, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993-0002, USA.
Abstract:
The Office of Study Integrity and Surveillance (OSIS) in CDER in FDA coordinates and conducts inspections of sites conducting bioavailability and/or bioequivalence (BA/BE) studies supporting regulatory submissions. In response to travel restrictions during the SARS-CoV-2 (COVID-19) public health emergency, OSIS developed and began conducting remote assessments of BA/BE sites in 2020. This paper provides an overview of remote regulatory assessments (RRAs) and OSIS's approach to RRAs, including procedures, experiences, and examples of findings during RRAs. In addition, as OSIS continues to utilize RRAs while resuming inspections, some areas for improvement are discussed.
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