FDA launches model-informed drug development pilot

FDA began a model-informed drug development (MIDD) pilot program to facilitate the development and application of exposure-based, biological and statistical models derived from preclinical and clinical data sources.

The agency committed to a series of workshops to enhance the use of MIDD under PDUFA VI, which was included as part of the FDA Reauthorization Act of 2017 (see BioCentury Extra, Aug. 18, 2017)...