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News From the Food and Drug Administration
August 15, 2017

Faster Orphan Drug Decisions

JAMA. 2017;318(7):604. doi:10.1001/jama.2017.10130

The FDA has announced that it will eliminate the backlog of existing requests for orphan drug designation by September 21. Going forward, the agency also pledged to respond to all requests for the designation within 90 days of receipt.

Although the FDA currently has about 200 pending requests for orphan drug designation, agency officials said the number of requests has increased steadily for the past 5 years. The 568 new requests that the FDA’s Office of Orphan Products Development received in 2016 was more than double the number received in 2012.

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