> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Rare Disease Innovation Hub 2026 Strategic Agenda
- URL: https://www.fdaweb.com/rare-disease-innovation-hub-2026-strategic-agenda/
- Published: 2026-02-17T12:00:00.000Z
- Updated: 2026-09-14T13:33:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160675

Having operated since its Fall 2024 inception with no dedicated budget and only the director as a full-time staff member, the FDA Rare Disease Innovation Hub is poised to move forward in 2026 with $1 million in funds from CBER and CDER and a small dedicated staff. The Hub is a point of collaboration and connectivity between the agency’s medical product Centers and rare disease programs to improve outcomes for rare disease patients.

Its stated goals are to:

- further advance the regulatory science of rare disease therapies;
- enhance and strengthen coordination and alignment between medical product Centers; and
- create a centralized point of contact for external partners.

The Hub’s [Strategic Agenda 2026](https://www.fda.gov/media/185144/download?attachment&ref=fdaweb.com) projects these 2026 actions:

- rare disease innovation, science, and exploration workshop series;
- patient and patient organization engagement in the development and review of drugs for rare diseases;
- promote knowledge-sharing between medical product Centers on rare disease treatment review;
- rare disease review staff training feedback pilot;
- public, agency-wide rare disease newsletter;
- website-based rare disease roadmap;
- hosting FDA Rare Disease Day 2026; and
- encourage Hub interaction with the community at multiple meetings and conferences.