Existing Diseases Orphaned: Proposed Rule May Split Large Classes Into Subsets
FDA will amend its orphan drug regulations to specify the requirements for a disease subset to qualify as a rare disease for the purpose of orphan designations
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"Based on our surveys of patient groups and sponsors and our review of the FDA database on designations and approvals, we conclude that no regulatory or legislative changes are needed at this time," General Accounting Office report on the Orphan Drug Act concludes