1:30 PM
Apr 16, 2018
 |  BC Extra  |  Politics & Policy

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...

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