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                Prescription Drug User Fee Amendments

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          Prescription Drug User Fee Amendments
          FDA-led Patient-Focused Drug Development (PFDD) Public MeetingsPrescription Drug User Fee Amendments FDA-led Patient-Focused Drug Development (PFDD) Public Meetings
  
  	
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People living with a condition are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the Patient-Focused Drug Development (PFDD) initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. PFDD meetings are unique among FDA public meetings, with a format designed to engage patients and elicit their perspectives on two topic areas: (1) the most significant symptoms of their condition and the impact of the condition on daily life; and, (2) their current approaches to treatment.

From 2012 to 2017, under the fifth authorization of PDUFA (PDUFA V), FDA conducted 24 disease-specific patient-focused drug development (PFDD) meetings to more systematically obtain the patient perspective on specific diseases and their treatments. PFDD meetings provide key stakeholders, including FDA, patient advocates, researchers, drug developers, healthcare providers, and others, an opportunity to hear the patient’s voice. The lessons learned include but are not limited to specific experiences that matter most to patients, patient perspectives on meaningful treatment benefits and how patients want to be engaged in the drug development process.

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. Links to meeting materials, including transcripts, webcast recordings, presentation slides, and Voice of the Patient reports can be found on the Condition-Specific Meeting Reports webpage. More information on this webpage can be found below.

Upcoming FDA-led PFDD Meetings

PFDD Meeting for Long COVIDCondition-Specific Meeting Reports

This webpage hosts an alphabetical listing of condition-specific meeting reports and other information related to patients’ experience. These meetings include FDA-led Patient-Focused Drug Development (PFDD) meetings, Externally-led PFDD meetings, and Patient Listening Sessions.



To contact FDA’s CDER Patient-Focused Drug Development Program Staff, please email patientfocused@fda.hhs.gov.

To get updates about CDER's Patient-Focused Drug Development programs, subscribe to our free email subscription service using the button at the top of the page.

Back to CDER Patient-Focused Drug Development Homepage

                                                                                  Content current as of:
      02/23/2023Prescription Drug User Fee Amendments
 
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