USA – FDA to Allow Online Submissions of Orphan Designation Requests

As part of work building on the US Food and Drug Administration’s (FDA) orphan drug modernization plan from 2017, the agency said Friday that later this year it will move from a paper-based process to a new cloud-based online submission portal for orphan drug designation requests.

The shift to online submissions will ease the process of making orphan drug designation requests, which are currently mailed into the Office of Orphan Products Development (OOPD) on a CD.

“The Orphan Drug Technology Modernization effort will allow for a more connected information technology system, advanced analytics, and improvements in facilitating knowledge management. In addition, it will provide external sponsors with more efficient submission of documents and enhanced direct communication with the FDA,” Amy Abernethy, principal deputy commissioner and acting CIO and Janet Maynard, director of FDA’s OOPD, wrote in a blog post.

Abernethy and Maynard said this effort is also part of FDA’s technology modernization plan