Orphan Drug Designation Requests and Designations Dipped in 2018, But Orphan Approvals Are Up Again!

In 2018, which marked the 35th anniversary of the passage of the Orphan Drug Act, FDA’s orphan drug program continued to go strong.  Orphan drug designation requests and orphan drug designations dipped compared to 2017 (see our previous post here), but aren’t too shabby.