FDA Announces Strategic Plan to Eliminate Orphan Designation Request Backlog

The number of orphan designation requests has more than doubled in the last five years. Last fiscal year saw 568 new requests, and as of July 2017 there are 200 pending review. The announcement of the new Orphan Drug Modernization Plan comes one week after the new FDA Commissioner committed to eliminating the backlog within 90 days. The plan anticipates response to all new requests for designation within 90 days of receipt. Here’s the full FDA News Release and here is a link to contact PDG for help with your request for orphan drug designation.