THE US Food and Drug Administration has unveiled a new plan to address a significant backlog of requests for orphan designation of new medicines.
The Orphan Drug Modernisation Program follows a commitment by FDA Commissioner Scott Gottlieb to slash the queue within 90 days.
The program provides orphan status to drugs and biologics for the treatment of diseases that affect less than 200,000 people in the US.
Currently there are 200 requests pending review, and the FDA will now deploy a "Backlog SWAT team" of experienced reviewers who will exclusively focus on the backlogged applications.
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