Division of Clinical Research

Office of the Vice President and Innovation

April 14, 2021

During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities that manufacture FDA-regulated products. These tools include record requests in advance of or in lieu of a drug facility inspection, relying on information from trusted regulatory partners, and remote interactive evaluations (such as remote livestreaming video of operations, teleconferences and screen sharing). We have used some or all of these approaches to evaluate facilities for human and animal medical products during the public health emergency when inspections of drug facilities were not possible due to travel or quarantine restrictions.

Inspections are an important tool to keep Americans safe, and are part of a set of tools used for regulatory oversight. As part of the wide variety of tools we have deployed during the COVID-19 pandemic, remote interactive evaluations have informed the FDA’s regulatory decision-making, contributed to ensuring drug quality and helped determine the scope, depth and timing of future inspections. By necessity, we have adapted by conducting more remote interactive evaluations throughout the public health emergency and are continuing to expand their use as appropriate. The purpose of this new guidance is to provide further clarity for regulated facilities on how the FDA will request and conduct these remote interactive evaluations during the COVID-19 public health emergency.

We recognize that remote interactive evaluations do not replace inspections, and that there are situations where only an inspection is appropriate based on risk and history of compliance with FDA regulations. Within the exceptional context of a global pandemic, we see remote interactive evaluations as part of a necessary strategy to evaluate medical product facilities by using all available approaches to ensure the medical products we regulate are safe, effective and of high quality.

Click here to read the full guidance: https://www.fda.gov/news-events/press-announcements/fda-provides-guidance-remote-interactive-evaluations-oversight-drug-facilities-during-covid-19

Categories FDA Regulatory

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