Tuesday, November 29, 2016 9:17:53 AM
Thanks
The FDA grants orphan drug designation to investigational drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the United States. The idea behind the Orphan drug status is to facilitate drug development for rare diseases that may provide several benefits to drug developers, including assistance with clinical study design and drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.
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