Learn more about Patient Engagement

Patients are at the heart of what the FDA does and are vital to our work protecting the public health by ensuring the safety and efficacy of drugs, biological products, and medical devices. Your experience can help inform our understanding of your medical condition, as we move from early stages in research to the later stages of approving new products.

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FDA Patient Engagement Overview

FDA Patient Engagement Partnerships

FDA Patient Engagement Opportunities

FDA Resources for Patients

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History of Patient Engagement at FDA

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• 2019
  

  • Patient Affairs Staff (PAS) online webform, Patients Ask FDA, launched

  • Public Workshop held on Patient-Focused Drug Development (PFDD) Guidance 4: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making

  • Draft of PFDD Guidance 2 released: Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders

• 2018
  

  • Memorandum of Understanding established with National Organization for Rare Disorders (NORD) to launch Patient Listening Session pilot program

  • Patient Engagement Collaborative (PEC) launched with Clinical Trials Transformation Initiative (CTTI)

  • Center for Devices and Radiological Health (CDRH) Patient & Caregiver Connection (P&CC) program launched

  • Public Workshops held on PFDD guidances:

    • Guidance 2: Methods to Identify What is Important to Patients
    • Guidance 3: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcome Assessments
    • Guidance 5: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

  • Draft PFDD guidance documents released:

    • Guidance 1: Collecting Comprehensive and Representative Input
    • Guidance 5: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data
• 2017
  

  • PAS established in the Office of the Commissioner

  • Public Workshop held on PFDD Guidance 1: Collecting Comprehensive and Representative Input

• 2016
  

  • FDA and European Medicines Agency (EMA) Patient Engagement Cluster created

  • First Patient Council (internal) meeting held

• 2015
  

  • Patient Preference Information (PPI) framework and guidance released for CDRH medical device decision-making

  • Patient Engagement Advisory Committee (PEAC) meeting launched to discuss medical devices

• 2013
  

  • Internal working group established to discuss ways to increase Patient Involvement in FDA processes

  • New consumer-friendly form launched for reporting medical product problems through the FDA MedWatch system

• 2012
  

  • A section of the FDA website is created specifically For Patients

  • PFDD Initiative launched

• 2008
  

  • Patients and consumers are encouraged to report medical product problems using the existing FDA MedWatch system

• 2001
  

  • FDA Patient Representative® role expanded to serve as consultants to scientific and regulatory reviewers

• 1996
  

  • FDA Patient Representatives® received voting rights on advisory committees

• 1993
  

  • Office of AIDS Coordination renamed to Office of AIDS and Special Health Issues (OASHI) with the scope expanded 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