FDA Announces Plan for Electronic Orphan Drug Designation Submissions

January 27, 2020

The FDA plans to allow sponsors to submit orphan drug designation requests electronically later this year.

The submission process will switch to a cloud-based, online submission portal. The move is part of the agency’s Orphan Drug Technology Modernization effort.

In addition to the new portal, the modernization effort includes a new workflow management tool that will facilitate key tasks necessary to review an orphan drug designation.

The effort will “allow for a more connected information technology system, advanced analytics, and improvements in facilitating knowledge management,” according to Amy Abernethy, the FDA’s principal deputy commissioner, and Janet Maynard, director of the Office of Orphan Products Development.

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