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                For Patients

For Patients

                        Learn About Your Medicines


                        Clinical Trials: What Patients Need to Know
          Rare Diseases at FDA
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          Learn About FDA Patient Engagement Home
          For Patients
          Evolution of Patient Engagement at the FDAFor Patients Evolution of Patient Engagement at the FDA
  
  	
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Evolution of Patient Engagement at the FDA
                    2020
                    COVID-19 Patient resources page Launched; Final PFDD guidance 1 released; Muscular Dystrophy Association webinar on COVID-19; FDA and NORD listening session on COVID-19 impact on rare disease communities
                    2019
                    FDA launched Patients Ask FDA; PFDD workshop on  guidance 4; Draft PFDD guidance 2 released
                    2018
                    Memorandum of Understanding with National Organization For Rare Disorders launched the Patient Listening Session pilot program; Patient Engagement Collaborative launched with Clinical Trials Transformation Initiative; Center for Devices and Radiological Health Patient & Caregiver Connection program launched public workshops on PFDD guidances and drafts released
                    2017
                    Patient Affairs Staff (PAS) established in the Office of the Commissioner; Public Workshop on PFDD guidance; PEAC meetings regarding medical devices
                    2016
                    FDA and European Medicines Agency Patient Engagement Cluster created; First Patient Council (internal) meeting held
                    2015
                    Patient Preference Information framework and guidance for medical device decision making; Patient Engagement Advisory Committee (PEAC) announced in the Federal Register
                    2013 
                    Internal working group examined ways to increase patient involvement in FDA processes; Consumer-friendly form introduced in FDA’s MedWatch system to report medical product problems
                    2012
                    FDA launched For Patients on the web; Patient-Focused Drug Development (PFDD) initiative launched
                    2008
                    Patients and consumers encouraged to report medical product problems using FDA’s existing MedWatch system
                    2001
                    First FDA Patient Representative Program role expanded to serve as consultants to scientific and regulatory reviewers
                    1996
                    First FDA Patient Representatives received voting rights on advisory committees
                    1993
                    Office of AIDS Coordination renamed to Office of AIDS and Special Health Issues and broadened to include patients with cancer and other serious and life-threatening diseases; First FDA Patient Representative served on an advisory committee
                    1988
                    Office of AIDS Coordination established

                                                                                  Content current as of:
      07/08/2021For Patients

          
                        Learn About Your Medicines


                        Clinical Trials: What Patients Need to Know
          Rare Diseases at FDA
          Guide to Submitting Comments to the FDA
          Learn About Drug and Device Approvals
          Learn About Expanded Access and Other Treatment Options
          Learn About FDA Patient Engagement
 
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