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  1. Prescription Drug User Fee Amendments

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

Under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), FDA conducted 24 disease-specific Patient-Focused Drug Development (PFDD) meetings to more systematically gather patients’ perspectives on their condition and available therapies to treat their condition. FDA recognizes the value of gathering patient input through PFDD meetings and continues to host disease-specific PFDD meetings. Following each PFDD meeting, FDA summarized the input shared by patients and patient representatives in a Voice of the Patient report. The Voice of the Patient reports summarize the input provided by patients and patient representatives at each of these public meetings.

The Voice of the Patient Reports

Related Information

Patient Focused Drug Development

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