Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Learn About FDA Patient Engagement

Learn About FDA Patient Engagement

                        About the FDA Patient Representative Program
          When a Patient Speaks: Testimonials from FDA Patient Representatives
          How to Apply to the FDA Patient Representative Program
          FDA Patient Engagement Overview*
          FDA Patient Listening Sessions
          Patients Ask FDA
          Patients Matter Video Series
          Patient Engagement Collaborative
          Patient Engagement Cluster
          About the FDA and How You Can Get Involved


                        FDA Patient Engagement Opportunities Home
          For Patients
          Learn About FDA Patient Engagement
          FDA Patient Engagement PartnershipsLearn About FDA Patient Engagement FDA Patient Engagement Partnerships
  
  	
    Share
    Post
    Linkedin

    Email
    Print**On this page:**

Clinical Trials Transformation Initiative (CTTI)
	National Organization for Rare Disorders (NORD)
	Reagan-Udall Foundation
	European Medicines Agency (EMA)


Clinical Trials Transformation Initiative (CTTI)

CTTI Logo
 The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership that brings together organizations and individuals representing academia, clinical investigators, government and regulatory agencies, industry, institutional review boards, patient advocacy groups, and others, to develop evidence-based solutions to clinical research challenges. FDA and CTTI are currently collaborating on the Patient Engagement Collaborative (PEC). The PEC is composed of patient organization and individual representatives who discuss topics focusing on enhancing patient engagement in medical product development and regulatory discussions at FDA.
For more information about FDA and CTTI’s Patient Engagement Collaborative (PEC)
	For more information about CTTI


National Organization for Rare Disorder

National Organization for Rare Disorders
 The National Organization for Rare Disorders (NORD) works with individuals with rare diseases and the organizations that serve them. NORD, along with its more than 300 patient organization members, is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and patient services. FDA has a Memorandum of Understanding (MOU) with NORD to conduct outreach on ways to enhance incorporating patient experiences into regulatory discussions. FDA and NORD are working together on FDA Patient Listening Sessions with rare disease patients, caregivers and advocates to enhance FDA’s clinical and regulatory understanding of diseases and conditions and provide a common understanding of the most urgent needs of patients, caregivers and advocates."
For more information about FDA and NORD’s Memorandum of Understanding (MOU)
	For more information about NORD


Reagan-Udall Foundation

Reagan-Udall Foundation logo
 The Reagan-Udall Foundation for the Food and Drug Administration (the Foundation) is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.” The Foundation serves as a bridge between the FDA and the public, providing a means for the FDA to interact directly with stakeholders, including industry and consumers, and work together in a transparent way to establish novel, scientific collaborations. Through this collaboration, the Office of Patient Affairs and the Foundation are working together on FDA Patient Listening Sessions to enhance FDA’s clinical and regulatory understanding of diseases and conditions and provide a common understanding of the most urgent needs of patients, caregivers and advocates.
For more information about the Reagan-Udall Foundation for the Food and Drug Administration
	For more information about the FDA Patient Listening Session program


European Medicines Agency (EMA)

EMA
 The European Medicines Agency (EMA) and patients have been actively interacting since the creation of the EMA in 1995. Patients and patient groups bring a 'real-life' experience as well as specific knowledge and expertise to scientific discussions on medicines and on the impact of regulatory decisions. The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) collaborate on patient engagement activities through the FDA/EMA Patient Engagement Cluster. The cluster allows FDA and EMA to share best practices involving patients along drug and biologic regulatory lifecycles. Information that is discussed is covered by confidentiality agreements signed by the FDA and EMA.
For more information about FDA and EMA’s Patient Engagement Cluster
	For more information about EMA’s patient engagement activities

                                                                                  Content current as of:
      05/16/2022
              
              
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  			     Medical Devices
			     			  			     Radiation-Emitting ProductsLearn About FDA Patient Engagement

          
                        About the FDA Patient Representative Program
          When a Patient Speaks: Testimonials from FDA Patient Representatives
          How to Apply to the FDA Patient Representative Program
          FDA Patient Engagement Overview*
          FDA Patient Listening Sessions
          Patients Ask FDA
          Patients Matter Video Series
          Patient Engagement Collaborative
          Patient Engagement Cluster
          About the FDA and How You Can Get Involved


                        FDA Patient Engagement Opportunities
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop