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April 14, 2021
Dear International Colleague,
Today, FDA announced the availability of a guidance entitled, “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency.” This guidance describes various interactive and virtual tools we may request to use at a facility to conduct an evaluation. We refer to our use of any combination of these interactive tools as a remote interactive evaluation. This guidance describes how remote interactive evaluations will be requested and conducted for the duration of the COVID-19 public health emergency at any facility where pharmaceutical products, including biological products, are manufactured, processed, packed or held. This includes sites covered under FDA’s bioresearch monitoring program and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA will use existing risk management methods and related tools to determine when to request a facility’s participation in a remote interactive evaluation. FDA conducts inspections for many purposes and programs, including pre-approval and pre-license, post-approval, surveillance, for-cause and bioresearch monitoring programs. We will consider each of those inspection program areas as possible candidates for remote interactive evaluations.
FDA intends to use information from remote interactive evaluations to meet user fee commitments and to update facilities information. Facilities can choose to decline FDA’s request to perform a remote facility evaluation; however, this may impede our ability to evaluate the facility or product and make a timely regulatory decision. FDA is using available tools and sources of information to support regulatory decisions and oversight with respect to facilities impacted by FDA’s reduced ability to conduct inspections because of COVID-19.
Acting FDA Commissioner Janet Woodcock, M.D. issued the following comment in response to this guidance:
"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."
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