USA – FDA updates guidance on remote regulatory assessments

The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both mandatory and voluntary RRAs going forward.

“FDA’s experiences have identified significant benefits in using RRAs. For instance, RRAs have assisted FDA in verifying corrective actions taken in response to inspections of previously compliant manufacturers and in gaining compliance insight when it was not practicable to inspect,” the agency wrote in the revised draft guidance. “RRAs have also provided information about deficient practices, leading FDA to take regulatory actions and/or conduct inspections, as well as informing future inspection planning.”

The revised guidance, published on 26 January 2024, provides an update to a draft guidance document issued in July 2022 (RELATED: FDA describes plans to expand remote regulatory assessments, Regulatory Focus 22 July 2022). Along with incorporating public comments, the latest guidance was revised to align with provisions of the Food and Drug Omnibus Reform Act of 2022 that make more establishments subject to mandatory records requests from the FDA…