FDA answers Questions on Remote Regulatory Assessments

Recommendation

28/29 May 2024
Copenhagen, Denmark

Quality Oversight
Supervision of the Pharmaceutical Quality System: Challenges and Opportunities

In response to the Covid-19 pandemic, the FDA had adapted its workflows for on-site inspections. In view of the travel restrictions, the authority also used various types of remote assessments, summarised under the term Remote Regulatory Assessments (RRAs). RRAs were mainly used to support submissions or applications assessments of FDA-regulated products and to reduce delays. RRAs include activities for which the FDA may use different terminology, such as "remote interactive evaluations" and "remote record reviews".

According to the FDA, experience to date has shown that the use of RRAs has a number of benefits, including in terms of corrective actions following an inspection or simply in gaining knowledge about a site's compliance when an on-site inspection was not possible. Similarly, observations were made in the course of conducted RRAs that prompted the FDA to take further regulatory action, conduct inspections and support the planning of future inspections.

In 2022 the FDA had developed and published a Draft Guidance for Industry: Conducting Remote Regulatory Assessments - Questions and Answers. This document was intended to provide answers to frequently asked questions related to RRAs and ultimately facilitate FDA's process for conducting remote assessments. Now there is another version with additional questions and answers (in a draft guidance).