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Here an example of what we can offer. FDA Approves a New Dose of #INGREZZA (#Valbenazine) for Treatm

The development program for this sNDA was facilitated via meetings under the Prescription Drug User Fee Act (PDUFA) VI Model-Informed Drug Development (MIDD) Paired Meeting Pilot Program. MIDD is an approach that involves developing and applying exposure-based, biological, and statistical models derived from preclinical and clinical data sources to inform drug development and decision-making. It aims to integrate information from diverse data sources to help decrease uncertainty and lower failure rates and to develop information that cannot or would not be generated experimentally. For additional information on the MIDD Paired Meeting Pilot Program, please visit https://go.usa.gov/xdtdP.



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