FDA Guidance Breakdown: Remote Interactive Evaluations (RIEs) of Drug Manufacturing and Bioresearch Monitoring Facilities

A new draft guidance from the FDA outlines the agency’s approach for planning and conducting remote interactive evaluations of pharmaceutical and biologics facilities.

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On October 25, the FDA issued new draft guidance to describe how it requests and conducts voluntary remote interactive evaluations (RIEs) at facilities where drugs are manufactured, processed, packed, compounded, or held, and at drug facilities covered under the FDA’s bioresearch monitoring (BIMO) program.

The guidance covers preapproval inspections, prelicense inspections, postapproval inspections, surveillance inspections, follow-up and compliance inspections, and BIMO inspections.

It replaces an earlier version issued in April 2021.

Background

The FDA introduced the concept of RIEs as a tool to evaluate drug manufacturing and bioresearch monitoring facilities. RIEs are not inspections but are used to assess compliance with the FD&C Act and its implementing regulations. The guidance provides recommendations for planning, conducting, and concluding an RIE.

During the COVID-19 pandemic, the FDA expanded its use of alternative tools for evaluating drug manufacturing facilities to support regulatory decision-making. This was especially crucial when traditional inspections were not feasible due to the public health emergency.

Now, while traditional inspections have largely resumed, the FDA recognizes the value of these alternative tools. The agency believes that continuing to use tools like RIEs, based on risk and program needs, will enhance its ability to assess facilities effectively.

The agency is clear to note that a Remote Interactive Evaluation is not an inspection as described in specific sections of the FD&C Act. Instead, it's an alternative tool that can be used in conjunction with or in place of certain inspections.

Planning a Remote Interactive Evaluation

The guidance explains three main components of selecting and notifying a facility of an RIE: