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# ORA Embraces Remote Evaluations in Post Pandemic Arena
- URL: https://www.fdaweb.com/ora-embraces-remote-evaluations-in-post-pandemic-arena/
- Published: 2021-11-09T12:00:00.000Z
- Updated: 2026-09-14T17:21:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150547

FDA’s Office of Regulatory Affairs has embraced the flexibility and information-enhancing abilities that alternative inspection tools, such as remote interactive evaluations, have provided agency compliance and enforcement staff during the pandemic, and they will continue to be available long after Covid-19 ends. Speaking at the virtual *Association for Accessible Medicines generics and biosimilars conference 11/9,* ORA Medical Products and Tobacco Operations assistant commissioner **Elizabeth Miller** acknowledged that while FDA does not intend to replace traditional inspections with remote interactive evaluations (RIE), it will, however, use inspections supplemented by additional tools (e.g. hybrid inspections), such as requests to participate in teleconferences, live streaming video of a facility operations, screen sharing of records or other real time activities. “In other words, we're asking firms to create or do something other than produce a document that they are required to maintain,” she said.

“RIEs are not the same as an inspection,” Miller noted, adding that as the agency learns more and decides how and when these and other tools can be used, “we commit to having transparent dialogs with regulated industry as to how this may affect our procedures in the future.”

Internationally, Miller said ORA is working in collaboration with other regulators to share their alternative inspection experiences. “As with all regulators, we are evaluating how these remote tools and activities provide assurances and efficiencies,” she said. “There have been a number of other forums where the inspectors have shared best practices on remote activities. And the latest news from the Pharmaceutical Inspection Cooperation Scheme or PICS is that a new workgroup under the U.S.-chaired strategic development subcommittee is forming on remote assessments. This working group will be addressing the challenges posed by the various terminology used to describe our activities, such as desktop session assessments, virtual evaluations, and so on. They intend to work towards standard nomenclature and definitions and will evaluate how these remote activities could relate to the inspection reliance guidance.”

Miller also said that FDA has expanded “mutual reliance” with international regulators not operating under any formal mutual recognition agreement that permits assessment of third-country reports. “In other words, if a European authority conducted a foreign inspection, we would request and review those reports for consideration of updating our systems and data to be potentially used to inform our own risk models,” she told the conference.  

“Our experiences shared with foreign regulators have proven invaluable, and though many may differ on terminology, it is apparent that many of our processes and procedures can be converged,” Miller continued. “Experience to date is that the remote assessments are a lot more time-consuming for both sides. For the inspected community, there is a need for a large amount of documentation to first be collected and then prepared, scanned and uploaded. And for the inspectors and investigators, communication with the inspected firm is generally impaired compared to facility inspections due to technical limitations and time zone differences, among other things.”