13/14 June 2023
After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry", clarifying some of the plans to take when the agency cannot conduct an onsite inspection of a facility. FDA acknowledges the fact that on-site inspection activities are "limited due to factors including travel restrictions" and "intends to continue using alternative tools, when appropriate, to evaluate facilities".
The document explains what FDA deems as "mission-critical" and how it will ensure the quality of imported products while inspections are limited.
FDA states that it is "using all available tools and sources of information to support regulatory decisions on applications that include sites impacted by FDA's ability to inspect due to COVID-19." Examples:
FDA will not automatically send out a complete response (CR) letter to the applicant if FDA cannot conduct an inspection. "Decisions regarding applications will be based on the totality of the information available to FDA", this includes information obtained from use of the tools described in the Guidance. Decisions will then be made on all the available information. This can lead to the following decisions:
Further details can be found in the document.
A risk-based approach will be used to prioritize the inspections. This can include:
FDA also notes that applications can still be submitted if facilities in regions that are impacted by COVID-19-related travel restrictions are included.