FDA Seeks Feedback to Shape Rare Disease Innovation Workshop Series

The Food and Drug Administration is seeking public comments to help shape a future Rare disease Innovation, Science and Exploration (RISE) workshop series. Through the series, FDA aims to explore challenges that are common to multiple rare diseases or disease classes and to identify innovative solutions.

Led by FDA’s Rare Disease Innovation Hub, the workshops will convene drug developers, patient and disease organizations, academics, FDA regulators and reviewers, and other federal partners.

FDA encourages collaborative proposals that outline key challenges, propose expert speakers, and highlight how the topic may advance regulatory science and therapeutic development. The submission deadline is Dec. 31.