Six recommendations on NAMs by FDA

Summary

Continued research and collaboration on NAMs-driven safety assessment will need to continue as part of FDA for years to come. This is best achieved by leveraging an adaptive design model which will support the ongoing evolution of new NAMs while keeping abreast of continuing technological advancements. NAMs will need to be reliable and reproducible with strict quality control measures to minimize variability. We suggest that NAMs are best developed in a collaborative environment, with input from multiple teams and key opinion leaders with varied scientific input, advanced machine learning and data analytics tools applied across different disciplines. Qualification of specific NAMs for a matched context of use should be approved by FDA for use by its product regulators, accompanied by appropriate reviewer education and support. Following the presentation of this report, next steps will consist of FDA determining whether any of these recommendations will be implemented to drive the integration of NAMs for future regulatory decision-making. FDA’s position may be communicated at a future Science Board meeting or other venue as deemed appropriate by the Agency.