FDA Commits to Eliminating Orphan Drug Backlog by September

06:13 EDT 30 Jun 2017 | Genetic Engineering News

The FDA has unveiled a plan to eliminate its backlog of requests for orphan drug designations by September 21, then respond to all new designation requests within 90 days of receipt—actions the agency said would bring more such treatments to market and begin rolling back their prices. FDA Commissioner Scott Gottlieb, M.D., said the agency’s Orphan Drug Modernization Plan will begin by deploying a “Backlog SWAT team” to process the backlog of about 200 orphan drug designation requests, starting with the oldest requests. The team will consist of senior, experienced reviewers with “significant” expertise in orphan drug designation. The number of designation requests handled through the Orphan Drug Designation Program has risen steadily over the past five years, the FDA said. Last year, the agency’s Office of Orphan Products Development received 568 new requests for designation—more than double the number of requests received in 2012. “People ...

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