The FDA announced a “Rare Disease Framework Initiative” aimed at reworking how it regulates therapies for rare diseases. Under the plan, the agency intends to move away from one-size-fits-all policy and evaluate development and regulatory requirements on a condition-by-condition basis, spanning preclinical engagement through post-marketing obligations. The FDA said it will solicit patient and expert input and publish a fit-for-purpose framework, though it did not set a specific timeline for initial recommendations. Bloomberg News previously reported a target of February. Analyst Joseph Schwartz at Leerink Partners characterized the effort as less about lowering standards and more about reducing uncertainty in approvals—an issue that has long complicated rare disease trial design, endpoints, and evidence generation.