Dr. Brent Allan, Executive Medical Director at Sciformix

FDAs Guidance on Safety Assessment Committees – Podcast

Dr. Brent Allan

In clinical trials, a comprehensive understanding of the safety profile of the product requires the consolidation of safety data across the same molecule and class. Aggregation and analysis of data are particularly important with the FDAs guidance on Safety Assessment Committees where an independent party is responsible for reviewing aggregate data in real time to alert investigators or regulators about any safety issues in the clinical trial.

Listen to Dr. Brent Allan talk about how companies can efficiently resource for and be compliant with the FDA’s recent guidance on Safety Assessment for IND safety reporting.