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U.S. Department of Health and Human Services

For Industry

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The Voice of the Patient: A Series of Reports from FDA's Patient-Focused Drug Development Initiative

FDA's Patient-Focused Drug Development initiative is a commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) that aims to more systematically gather patients’ perspectives on their condition and available therapies to treat their condition. As part of this commitment, FDA is holding at least 20 public meetings over the course of PDUFA V, each focused on a specific disease area. The Voice of the Patient reports will summarize the input provided by patients and patient representatives at each of these public meetings.