FDA ‘reset’ continues with new plan for reviewing rare disease drugs

The FDA on Oct. 14, 2026 unveiled the "Rare Disease Framework Initiative," a plan to "reimagine" how it regulates rare disease therapies by setting standards for individual conditions rather than a one-size-fits-all approach. The initiative will review policies from preclinical engagement through post-marketing requirements, seek patient and expert input, and, per Bloomberg News, targets initial recommendations for February. The agency will take feedback at an Oct. 28 meeting on its Silver Spring, Maryland campus.