Postmarketing requirements (PMRs) for drug development are often indicated by the FDA or EMA to gather additional information about a product’s safety, efficacy and optimal usage following product launch. When unexpected and unplanned, PMRs can significantly impact drug commercialisation costs and timing. 

Artificial intelligence or AI in drug development and machine learning offer potential benefits for more accurate forecasting of PMR needs early in the product development process and to better assess project risk. FDA AI drug development issues are some of the most discussed topics related to the FDA drug approval process. 

Cassandra is ICON’s powerful AI system that harnesses real world data on drugs and data obtained from the FDA postmarketing requirements and EMA postmarketing requirements databases. This information is analysed by Cassandra to accurately forecast whether postmarketing studies will be necessary to meet regulatory requirements and the types of studies involved. Cassandra offers up to 99% accuracy predicting the need for PMRs which can lead to optimisation of the FDA approval process and pharmaceutical market access.

Download now to learn how Cassandra can:

• Leverage the massive volume of drug approval data 
• Continually incorporate new and more current data 
• Improve decision-making accuracy
• Better leverage the commonalities and differences between FDA and EMA regulatory organisation decision-making processes