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Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned?
Session Chair(s)
Rajanikanth Madabushi, PHD
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER , FDA, United States
The PDUFA VI ‘goals letter’ identified MIDD and CID as enhancing regulatory decision tools. Starting in FY2018, the FDA committed to conduct pilot program for these. This session presents the experiences and learnings from the two pilot programs.
Learning Objective : Discuss the status and share experience of the MIDD and CID programs; Summarize high level insights on the scope and process of the programs.
Speaker(s)
Update on PDUFA VI MIDD Pilot Program
Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER , FDA, United States
Update on the PDUFA VI CID Pilot Program
Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Moderator
Director, Office of Clinical Pharmacology, OTS, CDER, FDA, United States
Panelist
Director, Division of Pharmacometrics, OCP, OTS, CDER, FDA, United States
Panelist
Head of Biostatistics, Johnson & Johnson Vision, United States
Panelist
Global Head, Clinical Pharmacology, Pfizer Inc, United States
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