Remote Oversight in Focus: Food and Drug Administration RRA Guidance and DSCSA Compliance

According to an article by ArentFox Schiff, the Food and Drug Administration (FDA) has issued guidance on the use of Remote Regulatory Assessments (RRAs), a tool that enables the agency to conduct oversight of regulated entities without requiring in-person visits. 

Originally implemented during the COVID-19 pandemic, RRAs have since evolved into a critical mechanism for maintaining regulatory visibility, particularly when travel is limited or targeted risk evaluations are needed. Through RRAs, the FDA can request documentation, hold virtual meetings, and use video tools to assess facilities. While RRAs are not formal inspections, they can influence decisions about enforcement or the need for future on-site visits.

This guidance arrives as the pharmaceutical industry prepares for key deadlines under the Drug Supply Chain Security Act (DSCSA). The DSCSA mandates extensive electronic documentation to track and trace prescription drugs across the supply chain, with manufacturer requirements already in effect and other trading partner requirements phasing in throughout the year. The convergence of RRAs and DSCSA obligations suggests that the FDA may increasingly rely on remote evaluations to ensure supply chain integrity and compliance, both domestically and internationally.

The article highlights that this signals a broader shift toward technology-enabled oversight. Maintaining thorough and timely electronic records, as well as being audit-ready for virtual Food and Drug Administration engagement, will be essential. Organizations that proactively align with both DSCSA and RRA expectations will be better positioned to navigate regulatory scrutiny and uphold public health standards.