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Evolution of Patient Engagement at the FDA


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Evolution of Patient Engagement at the FDA
                    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
                    FDA launched Patients Ask FDA; PFDD workshop on  guidance 4; Draft PFDD guidance 2 released
                    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
                    Patient Affairs Staff (PAS) established in the Office of the Commissioner; Public Workshop on PFDD guidance; PEAC meetings regarding medical devices
                    FDA and European Medicines Agency Patient Engagement Cluster created; First Patient Council (internal) meeting held
                    Patient Preference Information framework and guidance for medical device decision making; Patient Engagement Advisory Committee (PEAC) announced in the Federal Register
                    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
                    FDA launched For Patients on the web; Patient-Focused Drug Development (PFDD) initiative launched
                    Patients and consumers encouraged to report medical product problems using FDA’s existing MedWatch system
                    First FDA Patient Representative Program role expanded to serve as consultants to scientific and regulatory reviewers
                    First FDA Patient Representatives received voting rights on advisory committees
                    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
                    Office of AIDS Coordination established


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