In April 2026, Haystack Project announced its submission of a Petition for Rulemaking to the U.S. Food and Drug Administration (FDA) requesting that the FDA change how it reviews treatments for rare diseases. The request is for the FDA to adjust its rules so that each treatment is evaluated in a way that makes sense for that specific rare disease rather than using a one‑size‑fits‑all approach. This includes tailoring the study design, goals, and analysis to match how the disease works and how the treatment is expected to help. The petition also proposes that experts who specialize in each rare disease play a bigger, more formal role in deciding how studies are set up and what results should count as meaningful.

The Cutaneous Lymphoma Foundation supports this initiative and signed on to the Haystack Project's petition to the FDA.

You can learn more about the Petition on the Haystack Project here.