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

• The Voice of the Patient: Chronic Pain
  Public Meeting: 7/9/2018; Report date: 3/2019
• The Voice of the Patient: Opioid Use Disorder (OUD)
  Public Meeting: 4/17/2018; Report date: 11/2018
• The Voice of the Patient: Hereditary Angioedema
  Public Meeting: 9/25/2017; Report date: 5/2018
• The Voice of the Patient: Alopecia Areata
  Public Meeting: 9/11/2017; Report date: 3/2018
• The Voice of the Patient: Autism
  Public Meeting: 5/4/2017; Report date: 1/2018
• The Voice of the Patient: Sarcopenia
  Public Meeting: 4/6/2017; 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: 9/22/2015; Report date: 4/2016
• The Voice of the Patient: Non-Tuberculous Mycobacterial (NTM) Lung Infection
  Public Meeting: 10/15/2015; Report date: 4/2016
• 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
• The Voice of the Patient: 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: Narcolepsy
  Public Meeting: 9/24/2013; Report date: 6/2014
• The Voice of the Patient: Human Immunodeficiency Virus (HIV) Patient-Focused Drug Development
  Public Meeting: 6/14/2013; Report date: 3/2014
• The Voice of the Patient: Lung Cancer
  Public Meeting: 6/28/2013; Report date: 12/2013
• The Voice of the Patient: Chronic Fatigue Syndrome and Myalgic Encephalomyelitis
  Public Meeting: 4/25/2013; Report date: 9/2013

Related Information

• CDER Patient-Focused Drug Development
• FDA-Led Patient-Focused Drug Development Meetings
• Enhancing Benefit-Risk Assessment in Regulatory Decision-Making