FDA Rare Disease Innovation Hub Future Programming; Request for Comments

The Food and Drug Administration (FDA or the Agency) is announcing the following request for comments for a future public workshop series entitled "Rare disease Innovation, Science, and Exploration (RISE) Workshop." The purpose of the public workshops is to focus on challenges that are common to multiple diseases or a class of diseases, and for which evolving science offers innovative solutions. The workshops will primarily focus on cross-cutting or common issues and will not be focused on any specific product under review by the Agency. The Agency further welcomes comments that highlight general rare disease-related issues of potential interest for the FDA Rare Disease Innovation Hub (Hub) to inform its future activities.

Abstract as published in the Federal Register.

The comment window is still open until December 31, 2026. This is the point where industry shapes the final rule — submit comments through the Federal Register document below.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.