Zdrowie i gospodarka · 06/04/2018

FDA Requests Public Comments on Exposure-Response Analysis in Drug Development

The FDA is seeking public input on the use of exposure-response analysis in drug development and regulatory decision making, as part of the Prescription Drug User Fee Act of 2017 (PDUFA VI). The agency aims to clarify scientific policy and address obstacles to the use of this analysis in advancing model-informed drug development (MIDD).