Non-volatile residue provides important information for the exhaustive extraction process. What are the expectations from regulators on the reconciliation between NVR and the analytical data? What are labs capable of reconciling?

In this case study, a toxicologist will provide their perspective on the process of reconciling NVR data to analytical data during an FDA 510(k) submission. Lessons learned, including the importance of prompt laboratory communications and additional testing to reconcile NVR values will be presented.

Presenter: Lindsay Frankart PhD, MBA, DABT

This presentation, by Lindsay Frankart, was recorded at the Open House seminar, in Leuven, in April 2023 and is part of a series of videos.