Rachel Sher to Moderate Panel at Duke-Margolis FDA Convening September 3, 2025

On Wednesday, September 3, 2025, Manatt Health Partner will moderate a panel at the first of a series of hybrid public workshops co-convened by FDA’s Rare Disease Innovation Hub and the Duke-Margolis Institute for Health Policy titled, “On the RISE: Controls in Rare Disease Clinical Trials for Small and Diminishing Populations.” As FDA notes, the goal of these workshops is “to focus on the challenges that are common to multiple diseases or a class of diseases, and for which evolving science offers innovative solutions.” The September 3, workshop will explore considerations when choosing a control, discuss existing and innovative control options internal and external to the trial, and identify how these controls can be used to generate evidence that supports regulatory decision-making.

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