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Putting the Patient in Labeling (And Drug Approval Decisions) in ODE 1

Executive Summary

The Office of Drug Evaluation 1 (Cardio-Renal, Neurology, and Psychiatry) remains a bastion of FDA traditionalism. The long-time spiritual/intellectual leader of the group, Bob Temple, has been cautious about how to accept patient input into FDA approval criteria for drugs reviewed in these areas. Recent remarks by the ODE 1 division director, however, suggest that the patient’s perspective is very much now on the minds of this group.

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