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FDA issues long-awaited pandemic remote inspections guidance

Posted 14 April 2021 | By Michael Mezher 

FDA issues long-awaited pandemic remote inspections guidance

More than a year after the COVID-19 pandemic forced the US Food and Drug Administration (FDA) to halt most on-site inspections, the agency on Wednesday issued guidance detailing its approach to remote interactive evaluations of drug and biomedical research facilities during the public health emergency.
 
Teleconferencing, livestreaming video and screen-sharing technologies are among the tools FDA says it will use when it determines that a remote interactive evaluation is appropriate for a particular facility. Remote interactive evaluations will be considered for all of FDA’s drug inspection programs including preapproval and prelicense inspections, post-approval inspections, surveillance inspections and follow-up and compliance inspections.
 
While FDA has resumed conducting a limited number of on-site foreign and domestic inspections and has relied on alternative tools such as records requests and product sampling to complement its oversight activities, the agency now faces a looming backlog that threatens to derail its inspections commitments. (RELATED: Inspections: GAO calls on FDA to plan for backlog, review alternatives, Regulatory Focus 1 February 2021; FDA’s inspection backlog: GAO raises concerns as delays mount, Regulatory Focus 9 March 2021).
 
"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,” said Acting FDA Commissioner Janet Woodcock.
 
Though remote interactive evaluations are not a one-to-one replacement for inspections, FDA says the evaluations may be used to support approval decisions for drugs; preclude the need for an inspection; support certain enforcement actions; or to rank or prioritize facilities for future inspections.
 
FDA says it will apply a risk management approach to determining when to request a remote interactive evaluation and that such evaluations may precede inspections to limit staff travel and time spent on-site during the pandemic.
 
After determining a remote interactive evaluation is appropriate, FDA says it will notify the facility or applicant and request confirmation of their willingness and ability to facilitate the technological aspects of the remote review.
 
Facilities may decline to undergo a remote interactive evaluation, but FDA warns that such decisions could lead to regulatory delays. “Declining FDA’s request to perform a remote interactive evaluation could impede our ability to make a timely regulatory decision (e.g., regarding adequacy of a clinical trial used in support of a pending application or adequacy of a drug manufacturing operation described in the application),” the agency writes.
 
FDA says it will not accept requests from applicants or facilities for remote interactive evaluations, adding that “such decisions depend on many factors and information not always known to applicants or facilities, and it would be too burdensome on all parties to establish a request-based program.”
 
While remote interactive evaluations may serve as an alternative to on-site inspections in some circumstances, certain factors may preclude such evaluations. For instance, data integrity and other compliance concerns would likely necessitate on-site inspections. FDA also notes that remote interactive evaluations cannot serve as replacements for surveillance inspections but may inform the necessary scope, depth and timing of a future inspection and that inspections will usually be required after warning letters, regulatory meetings or other enforcement actions.
 
FDA will also take a risk-based approach to remote interactive evaluations of bioresearch monitoring (BIMO) inspections and that information obtained from such evaluations will generally “be used to assess the facility’s conduct, including data reliability and human subject protections to determine the acceptability of BIMO studies for FDA’s application decision-making.”
 
Prior to any remote interactive evaluation, FDA will schedule a virtual meeting to go over logistics and expectations with facility staff.
 
During the remote interactive evaluations themselves, FDA says it may:
 
  • “Request and review documents, records, and other information (electronic systems).
  • Use livestream and/or pre-recorded video to examine facilities, operations, and data and other information.
  • Through the facility’s point of contact, schedule interviews and meetings to address any questions or concerns.
  • Evaluate a facility’s corrective actions (e.g., in response to a previous inspection or evaluation, or to the current remote interactive evaluation). An inspection instead of a remote interactive evaluation may be necessary to verify the adequacy of some corrective actions, or if evaluating the corrective actions remotely would unreasonably extend the duration of the remote interactive evaluation.
  • Provide verbal updates to the facility on observations and outstanding issues, whenever feasible.”
 
The agency also stresses that the quality of the remote connection, including internet connectivity, image quality and cameras used, is key to ensuring the smooth conduct of a remote interactive evaluation. “To the extent practicable, technologies employed also should allow access for remotely viewing and evaluating operations at the facility, as necessary (e.g., aseptic practices, equipment cleaning and set up, material weighing and dispensing, instrument set up, sampling, testing),” FDA adds.
 
Citing security reasons, FDA says it will only use its own IT platforms and equipment to host virtual interactions, including Microsoft Teams, Zoom for Government and Adobe Connect.
 
While FDA will usually request and review documents and other information ahead of a remote interactive evaluation, the agency says it may request additional documents and information during the evaluation and expects such requests to be satisfied “within a reasonable timeframe, similar to requests for documents or other information made during an inspection.”
 
Documents requested during the remote interactive evaluation should be provided in an electronic format or made accessible by screen sharing. Facilities should ensure that FDA is able to access encrypted and password-protected files and should be ready to provide PDF files of paper-based documents.
 
At the end of a remote interactive evaluation, FDA says it will hold a closeout meeting with facility management and provide a written list of observations to them. However, unlike in a typical inspection, FDA says the written list is not a final agency action or decision and that the agency will not issue a Form FDA 483 based on a remote interactive evaluation. Facilities are encouraged to respond to any observations during the discussion or to respond in writing to the agency within 15 business days.
 
FDA, Guidance

 

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