The Food and Drug Administration (FDA) published a request for comments in the Federal Register regarding their “Rare disease Innovation, Science, and Exploration (RISE) Workshop.”
The workshop series will focus on “challenges that are common to multiple diseases or a class of diseases, and for which evolving science offers innovative solutions.” Additionally, they “will not be focused on any specific product under review by the Agency.”
Submission requirements:
· A description of the proposed topic
· Suggested speakers and/or subject matter experts
· A description of the impact of the topic on the development and regulatory science of rare disease therapies
· The disease state(s) affected by the challenge highlighted in the submission
· If relevant, related FDA guidances or existing programs addressing the challenge highlighted in the submission
Comments can be submitted electronically or by mail and are due by December 31, 2025.
