Zdrowie i gospodarka · 17/04/2018

FDA Announces Pilot Program for Model-Informed Drug Development Approaches

The FDA is launching a pilot program to support model-informed drug development (MIDD) approaches in medical product development, as part of the Prescription Drug User Fee Act (PDUFA) Reauthorization Act of 2017, and will provide sponsors with the opportunity to meet with FDA staff to discuss MIDD approaches from 2018 to 2022.