Read Dr. Tim Coté‘s thoughts on the “Unwritten Rules” and “Written Rules” of Orphan Designation.
The Unwritten Rules of Orphan Designation WP
Dr. Coté defines the “Unwritten Rules” and Written Rules” of Orphan Designation based upon his experience as the former Director of the Office of Orphan Products Development. He defines those terms and provides extensive examples of its utilization with the ultimate goal of Orphan Designation.