Prescription Drug User Fee Act (PDUFA) > The Voice of the Patient: A Series of Reports from FDA's Patient-Focused Drug Development Initiative

Prescription Drug User Fee Act (PDUFA) > The Voice of the Patient: A Series of Reports from FDA's Patient-Focused Drug Development Initiative

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.

The Voice of the Patient Reports

• The Voice of the Patient: Huntington’s Disease (PDF - 824KB) 
  Public Meeting: 9/22/2015; Report date: 3/2016
• The Voice of the Patient: Functional Gastrointestinal Disorders (PDF - 306KB) 
  Public Meeting: 5/11/2015; Report date: 1/2016
• The Voice of the Patient: Chagas Disease (PDF - 311KB) 
  Public Meeting: 4/28/2015; Report date 11/2015
• The Voice of the Patient: Breast Cancer (PDF - 377KB) 
  Public Meeting: 4/2/2015; Report date: 9/2015
• The Voice of the Patient: Female Sexual Dysfunction (PDF - 383KB) 
  Public Meeting: 10/27/2014; Report date: 6/2015
• The Voice of the Patient: Idiopathic Pulmonary Fibrosis (PDF - 451KB) 
  Public Meeting: 9/26/2014; Report date: 3/2015
• The Voice of the Patient: Neurological Manifestations of Inborn Errors of Metabolism (PDF - 345KB) 
  Public meeting: 6/10/2014; Report date: 2/2015
• The Voice of the Patient: Pulmonary Arterial Hypertension (PDF - 334KB) 
  Public meeting: 5/13/2014; Report date: 12/2014
• Voice of the Patient Report: Fibromyalgia (PDF - 434KB) 
  Public meeting: 3/26/2014; Report date: 10/2014
• The Voice of the Patient: Sickle Cell Report (PDF - 365KB) 
  Public meeting: 2/7/2014; Report date: 10/2014
• The Voice of the Patient Report: Narcolepsy (PDF - 326KB) 
  Public Meeting: 9/24/2013; Report date: 6/2014
• The Voice of the Patient Report: Human Immunodeficiency Virus (HIV) Patient-Focused Drug Development & HIV Cure Research (PDF - 356KB) 
  Public meeting: 6/14/2013; Report date: 3/2014
• The Voice of the Patient Report: Lung Cancer (PDF - 356KB) 
  Public Meeting: 6/28/2013; Report date: 12/2013
• The Voice of the Patient Report: Chronic Fatigue Syndrome and Myalgic Encephalomyelitis (PDF - 267KB) 
  Public meeting: 4/25/2013; Report date: 9/2013

Related Information

• Patient-Focused Drug Development: Disease Area Meetings Planned for Fiscal Years 2013-2017
• Enhancing Benefit-Risk Assessment in Regulatory Decision-Making