Promoting Innovation in Medical Product Assessment: A Risk-based Framework for Evaluating Computational Models for Regulatory Decision-Making | FDA

Promoting Innovation in Medical Product Assessment: A Risk-based Framework for Evaluating Computational Models for Regulatory Decision-Making | FDA

New Spotlight on CDER Science on Promoting Innovation in Medical Product Assessment: A Risk-Based Framework for Evaluating Computational Models for Regulatory Decision-Making Computational modeling and simulation (M&S) have been recognized as powerful tools in facilitating drug and medical device development and regulatory research, with the capability to accelerate access to safe and effective products. Since M&S was named a strategic priority at FDA almost a decade ago, its use by FDA and industry has grown.