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Remote FDA inspections: new guidance released

  • FDA issued a draft guidance describing how it conducts remote regulatory inspections of manufacturing facilities during the application review.
  • The new regulations build on an experience with remote inspections during the COVID-19 crisis, and are expected to improve the timeliness of drug approval process.

The FDA has recently published a new draft guidance describing the remote oversight tools used for pre-approval evaluation of manufacturing facilities. The published regulations are expected to reduce the time to approval and facilitate the availability of innovative, generic and biosimilar drugs. The introduced oversight tools will also help agency to stay operational during the crisis situations, similar to the recent COVID-19 pandemic. They include remote evaluation of manufacturers’ records, remote interactive inspections of facilities as well as review of information supplied by foreign regulatory partners. The agency also sees potential benefits in supplementing the on-site inspection with remote resources. For example, virtual communication with external experts could increase the efficiency of inspections and support regulatory decision-making.

The FDA has successfully used the remote evaluation approach during the COVID-19 pandemic, and the new guidance builds on this extensive experience. The previous guidances focused largely on the COVID-19 public health emergency; now regulations become more universal and establish remote evaluation as a standard tool for regulatory assessment.

However, the agency stressed that the introduced procedures should not be treated as supplanting the ordinary inspections, but only as complementary tools serving to improve the timeliness of the drug approval process. The remote evaluation can be used only after the FDA determines (through risk analysis) that they are sufficient to ensure the high quality of manufactured drugs. Also, the guidance does not apply to other evaluations programs such as post-approval, surveillance or follow-up inspections.

It is important to note that remote facility evaluations are voluntary and applicant may refuse to participate, if he’s not capable of handling the virtual interactions with the FDA. However, this may come at the expense of prolonging the time to approval, especially when some extraordinary factors prevent the FDA from conducting timely on-site inspections.

  1. “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry DRAFT GUIDANCE”, FDA (September 2023).
  2. “FDA issues guidance on using remote oversight tools to help approve drugs”, FDA (September 21, 2023).