The U.S. Food and Drug Administration (FDA) is inviting members of the rare disease community to share feedback on current educational resources that support the development of safe and effective therapies for rare diseases. The FDA Docket (FDA-2026-N-1584-0001), Opportunity for Public Comment on Rare Disease Educational Materials from the Center for Drug Evaluation and Research’s Accelerating Rare Disease Cures Program and the Rare Disease Innovation Hub invites public comments from parties engaged in the design and conduct of rare disease clinical trials, including sponsors, investigators, patients, and patient advocates.
Two Opportunities to Provide Feedback
- Feedback on LEADER 3D Educational Materials
The Center for Drug Evaluation and Research’s Accelerating Rare Disease Cures (ARC) Program is requesting input on the clarity, relevance, and usefulness of its Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) educational materials from stakeholders engaged in rare disease drug development, including industry, academia, and federal partners. - Input on Educational Resources for Patients and Patient Organizations, and Biologics Developers
The Rare Disease Innovation Hub is also requesting information and feedback on existing and desired educational resources for patients, patient organizations, and developers of rare disease biologics.
How to Submit Comments and Deadline
To be considered, all comments must be submitted by April 3, 2026. To learn more about these opportunities and for submission guidelines, please download the Public Docket FDA-2026-N-1584-0001.
FDA Information
For FDA rare diseases information, please visit:
Center for Drug Evaluation and Research (CDER)
- Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) provides information about available rare disease drug development educational materials.
- Accelerating Rare Disease Cures (ARC) provides information about the Accelerating Rare Disease Cures Program.
Rare Disease Innovation Hub
- The Rare Disease Innovation Hub provides information about the Hub, answers to frequently asked questions, information about the Rare disease Innovation, Science, and Exploration (RISE) Workshop series, and access to the 2026 Strategic Agenda.
