FDA to allow online submissions of orphan designation requests
As part of work building on the FDA’s 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.
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