Evolution of Patient Engagement at FDA Text Description
1988
- HIV/AIDS patient group founded
1991
- HIV/AIDS group expands to include cancer and other special health issues
- First patient representative sits on FDA Advisory Committee
1996
- FDA patient representatives receive voting rights
2001
- 2001 Patient Representative Program expands; patients now serve as consultants to reviewers during review cycle
2006
- FDA establishes Health Professional Liaison Program
2008
- MedWatch encourages voluntary reporting
2012
- FDA Patient Network web page launched
- Patient-Focused Drug Development initiative established under PDUFA V
2013
- FDA working group established to discuss FDASIA section 1137 (evolved to become Patient Council)
2015
- FDA releases Patient Preference Information framework and guidance
- FDA holds inaugural Patient Engagement Advisory Committee
2016
- FDA-EMA Patient Engagement Cluster founded
- First FDA Patient Council meeting held
2017
- FDA Patient Affairs Staff Launched
- FDA launches Patient Engagement Collaborative with CTTI
- PFDD Methodological Guidances – PDUFA VI
2018
- FDA’s PAS establishes MOU with NORD- pilot listening sessions kick-off
- PFDD Draft Guidance 1 released
- 1st Patient Engagement Collaborative (PEC) meeting
- PFDD Guidance 2 & 3 public meeting
- CDRH establishes Patient & Caregiver Connection Program
2019
FDA's PAS launches online portal, Request to Connect