FDA is behind. According to an Endpoints article published several weeks ago, 52 New Drug Applications (NDAs) are delayed due to the pandemic backlog. FDA’s inspections dashboard, filtered here for drug- and device-related inspections, illustrates the precipitous drop in domestic and foreign inspections since the pandemic’s start.
At the recent WCG FDAnews FDA Inspections vSummit, titled “Virtual & On-Site Inspections: The Newest Normal,” we heard FDA state unequivocally that in-person on-site inspections are the “gold standard,” but we also heard that FDA is increasingly relying on remote records requests, Remote Regulatory Assessments (RRAs), and Remote Interactive Evaluations (RIEs) to address its backlog. At various conference presentations, including the SQA Annual Meeting in April 2021, and in some published information, FDA has expressed its preference for use of Box (box.com) for document exchange during remote inspection activities. We also have anecdotal evidence from our customers that during live inspections, FDA investigators have asked them to upload electronic documents to Box, rather than printing them out or exchanging them electronically via thumb drive, CD, or some other means.
Accordingly, we’ve integrated Box into Ready Room so our customers can transfer documents effortlessly without leaving the inspection environment. This feature lets our customers take advantage of Ready Room’s numerous benefits, including storyboards, staged requests, and videoconferencing, while still permitting them to deliver documents to FDA via the inspector’s preferred method. Ready Room lets users connect to one or more inspector’s shared Box folders, create subfolders, upload documents, and even update documents with new versions, all from the Ready Room inspection board. Thus eliminating the effort and the risk of mistakes inherent in downloading and tracking documents, switching applications, and uploading them again.
We aim to help our users answer questions confidently, deliver documents efficiently, and tell a quality story with each inspection. Ready Room’s integration with Box makes document delivery that much more efficient for FDA inspections and remote reviews.