USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.

USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.

Upcoming in the later part of 2020, we will see them move from a paper-based process to a new cloud-based online submission portal for orphan drug designation requests.

This new initiative would ease the process of making orphan drug designation requests, which are currently being physically mailed to the Office of Orphan Products Development (OOPD) on a CD, allowing an even connected information technology system alongside, advanced analytics and improvements in facilitating knowledge management.

Additionally, this change will provide external sponsors with an even more efficient submission of documents and enhanced direct communication directly with the FDA.