Existing Diseases Orphaned: Proposed Rule May Split Large Classes Into Subsets
Executive Summary
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
You may also be interested in...
Orphan, But Not Rare: Pipeline Is Full And Approvals Are Up
If current trends persist, in 2006 FDA could surpass the number of orphan status designations granted in the past two years
FDA To Provide Updates On Critical Path Opportunities List Projects
FDA will highlight the agency's involvement in Critical Path projects in the coming months, Deputy Commissioner for Operations Janet Woodcock said March 16
Orphan Drug Act
"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