Model Master File Framework: A Regulatory Path Advancing Modeling and Simulation Applications.

To advance drug product development, regulatory decision making, and improve patient care, FDA has committed to the quantitative medicine paradigm that involves, among others, quantitative in silico methodologies and tools developed based on nonclinical, clinical, and real-world sources. In this Perspective, Model Master File (MMF) submissions as Type V Drug Master Files (DMF) are discussed as a path towards this commitment.