Use of Remote Regulatory Assessment (RRA) for Site Evaluations during the COVID-19 Pandemic: The USFDA’s Office of Study Integrity and Surveillance (OSIS) Perspective

Abstract

Travel restrictions during the novel coronavirus, SARS-CoV-2 (COVID-19) public health emergency affected the U.S. Food and Drug Administration’s (FDA) ability to conduct on-site bioavailability/bioequivalence (BA/BE) and Good Laboratory Practice (GLP) nonclinical inspections. FDA’s Office of Study Integrity and Surveillance (OSIS) developed a remote regulatory assessment (RRA) as an alternate tool to evaluate the reliability and integrity of data from such studies submitted in marketing applications for drug approval. This manuscript provides a retrospective comparative evaluation of metrics from three pre-pandemic years (2017–2019) versus those of RRAs performed during the COVID-19 pandemic (2020–2022). More clinical inspections than analytical inspections were conducted during the pre-pandemic years, while this trend was reversed during the pandemic years. A normalized comparison of inspections and RRAs revealed that RRAs were able to identify potential concerns in study conduct and data reliability comparable to on-site BA/BE and GLP nonclinical study inspections. The number of studies, types of studies, and final classification of site evaluations were reviewed. During the pandemic years, fewer RRAs were performed by OSIS as compared with the number of on-site inspections performed by OSIS during the pre-pandemic years. This can be attributed in part to the dedication of resources for the development of the RRA approach, the need to focus all efforts on the highest priority sites, the limited availability of staff, or the lack of adequate data sharing software or audio-visual hardware at the sites.