For Patients

New Patient Engagement Initiative

The FDA and the Clinical Trials Transformation Initiative (CTTI) will be working together to create a new work group with patient advocacy organizations to talk about patient engagement at the FDA.

Coming Soon

This new initiative is part of the FDA’s continued commitment to raising greater patient involvement and input in the decisions that the FDA makes. A work group of external stakeholders was suggested from comments submitted to a Federal Register Notice asking for input from the public on the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 1137, Patient Participation in Medical Product Discussions aimed to enhance patient engagement (view report).

The FDA has included patients in FDA meetings since the late 1980’s and early 1990s when the FDA Patient Representative Program began . Over the past several years FDA has created new opportunities to include valuable patient perspectives during the review of unapproved drugs and medical devices and to consider those perspectives.

The FDA will leverage CTTI’s strengths in multi-stakeholder engagement to coordinate this new work group. CTTI, a public-private partnership, has a community of patient advocates and caregivers within its membership.

The new work group will create a forum to exchange:

  • information

  • ideas

  • experiences

on matters of interest to patients and patient advocates related to patient engagement at the FDA. The work group is modeled after the European Medicines Agency’s Patients’ and Consumers’ Working Partydisclaimer icon, which marks its 10th anniversary in 2016.

Additional details will be released as the work group develops.

Page Last Updated: 06/15/2017
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