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FDA Working To Eliminate Orphan Designation Backlog

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The U.S. Food and Drug Administration announced Thursday a plan to eliminate its existing orphan designation request backlog for orphan drugs. The Orphan Drug Designation Program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis and prevention of rare diseases affecting fewer than 200,000 people. The FDA committed to not only eliminate the backlog but also to ensure a timely response to all new requests for designation of orphan drugs within 90 days. Dr. Scott Gottlieb, commissioner of the FDA, said in a press release: "People who suffer with rare diseases are too often faced with no, or limited, treatment options, and what treatment options they have may be quite expensive due in part to significant costs of developing therapies for smaller populations".The plan is part of the agency's new Medical Innovation Development Plan aimed at making the FDA's policies and regulatory tools modern, efficient and risk based. http://www.upi.com/Health_News/2017/0... http://www.wochit.com This video was produced by YT Wochit News using http://wochit.com

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Food and Drug Administration orphan drug FDA Food And Drug Administration Fda Orphan Products Council Orphan Drug Pharmaceuticals Policy Drug Discovery Breakthrough Therapy Health UPI
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