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Evolution of patient engagement at FDA text alternative

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

Return to Patient Affairs Staff page