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The case for patient-controlled rare disease data across science, policy, and the lived experience.

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Vision

It is no longer good business to leave rare diseases behind

The math changed. The institutions that retool first capture leadership.

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This week

Regulatory

Our FDA Comment: AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program

Cureledger's May 27, 2026 comment to Docket FDA-2026-N-4390: rare disease as the pilot's most generalizable use case, within-person variability as the decision-quality threshold, privacy for cohorts under 100, and data custody that outlives the sponsor.

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Data Sovereignty

Preventing AI medicine's biggest trap for rare disease

Why AI drug discovery becomes extraction without ownership infrastructure.

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The rare disease singularity
Vision

The rare disease singularity

Four capabilities converged. Cures are reachable.

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Read all4 of 109 · Tag: Regulatory
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  1. May 27, 2026Our FDA Comment: AI-Enabled Optimization of Early-Phase Clinical Trials Pilot ProgramRegulatory
  2. Apr 22, 2026Our FDA Comment: Plausible Mechanism Framework Draft GuidanceRegulatory
  3. Apr 22, 2026The FDA Is Ready. The Infrastructure Is Not.Regulatory
  4. Apr 22, 2026The Regulatory Landscape Is Finally ReadyRegulatory
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