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. 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

• The Voice of the Patient: Chronic Pain
  Public Meeting: July 9, 2018; Report Date: 3/2019
• The Voice of the Patient: Opioid Use Disorder (OUD)
  Public Meeting: April 17, 2018 Report Date: 11/2018
• The Voice of the Patient - Hereditary Angioedema
  Public Meeting: September 25, 2017 Report Date: 5/2018
• The Voice of the Patient: Alopecia Areata
  Public Meeting: September 11 2017; Report Date: 3/2018
• The Voice of the Patient: Autism
  Public Meeting: May 4, 2017; Report Date: 1/2018
• The Voice of the Patient: Sarcopenia
  Public Meeting: April 6, 2017; Report date: 10/2017
• The Voice of the Patient: Organ Transplant
  Public Meeting: 9/27/2016; Report date: 4/2017
• The Voice of the Patient: Neuropathic Pain Associated with Peripheral Neuropathy
  Public Meeting: 6/10/2016; Report date: 2/2017
• The Voice of the Patient: Psoriasis
  Public Meeting: 3/17/2016; Report date: 11/2016
• The Voice of the Patient: Hemophilia A, Hemophilia B, von Willebrand Disease and Other Heritable Bleeding Disorders
  Public Meeting 9/22/2014; Report Date: 5/2016
• The Voice of the Patient: Parkinson's Disease
  Public Meeting September 22, 2015; Report Date: April, 2016
• The Voice of the Patient: Non-Tuberculous Mycobacterial (NTM) Lung Infection
  Public meeting: October 15, 2015; Report date: April, 2016
• The Voice of the Patient: Huntington'€™s Disease
  Public Meeting: 9/22/2015; Report date: 3/2016
• The Voice of the Patient: Functional Gastrointestinal Disorders
  Public Meeting: 5/11/2015; Report date: 1/2016
• The Voice of the Patient: Chagas Disease
  Public Meeting: 4/28/2015; Report date 11/2015
• The Voice of the Patient: Breast Cancer
  Public Meeting: 4/2/2015; Report date: 9/2015
• The Voice of the Patient: Female Sexual Dysfunction
  Public Meeting: 10/27/2014; Report date: 6/2015
• The Voice of the Patient: Idiopathic Pulmonary Fibrosis
  Public Meeting: 9/26/2014; Report date: 3/2015
• The Voice of the Patient: Neurological Manifestations of Inborn Errors of Metabolism
  Public meeting: 6/10/2014; Report date: 2/2015
• The Voice of the Patient: Pulmonary Arterial Hypertension
  Public meeting: 5/13/2014; Report date: 12/2014
• Voice of the Patient Report: Fibromyalgia
  Public meeting: 3/26/2014; Report date: 10/2014
• The Voice of the Patient: Sickle Cell Report
  Public meeting: 2/7/2014; Report date: 10/2014
• The Voice of the Patient Report: Narcolepsy
  Public Meeting: 9/24/2013; Report date: 6/2014
• The Voice of the Patient Report: Human Immunodeficiency Virus (HIV) Patient-Focused Drug Development
  Public meeting: 6/14/2013; Report date: 3/2014
• The Voice of the Patient Report: Chronic Fatigue Syndrome and Myalgic Encephalomyelitis
  Public meeting: 4/25/2013; Report date: 9/2013

Related Information

• CDER Patient-Focused Drug Development
• Patient-Focused Drug Development: Disease Area Meetings Planned for Fiscal Years 2013-2015
• Enhancing Benefit-Risk Assessment in Regulatory Decision-Making