Patient-Focused Drug Development: Disease Area Meetings Held in Fiscal Years 2013-2017
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 list of 24 disease-area PFDD meetings conducted under PDUFA V can be found below, along with links to individual meeting webpages where all meeting materials, including transcripts, webcast recordings and presentation slides are publicly available. Following each PFDD meeting, FDA summarized the input shared by patients and patient representatives in a Voice of the Patient report.
More information on the selection of disease areas for fiscal years 2013-2015 can be found in the Federal Register Notice (PDF - 111KB) published on April 11, 2013. More information on the selection of disease areas for fiscal years 2016-2017 can be found in the Federal Register Notice published on July 2, 2015.
Meetings Held in FY 2016 – 2017
- Hereditary Angioedema: September 25, 2017
- Alopecia areata: September 11, 2017
- Autism: May 4, 2017
- Sarcopenia: April 6, 2017
- Patients who have received an organ transplant: September 27, 2016
- Neuropathic pain associated with peripheral neuropathy: June 10, 2016
- Psoriasis: March 17, 2016
- CDER Patient-Focused Drug Development
- The Voice of the Patient: A Series of Reports from FDA's Patient-Focused Drug Development Initiative
- Enhancing Benefit-Risk Assessment in Regulatory Decision-Making
- Externally-led Patient-Focused Drug Development Meetings
- Plan for Issuance of PatientâFocused Drug Development Guidance