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In the December 23, 2014, Federal Register, FDA clarified its policy regarding certain aspects of orphan-drug exclusivity due to a recent court decision interpreting provisions of the Food Drug and Cosmetic Act...
United StatesFood, Drugs, Healthcare, Life Sciences
within Media, Telecoms, IT, Entertainment and International Law topic(s)
In the December 23, 2014, Federal Register,
FDA clarified its policy regarding certain aspects of orphan-drug
exclusivity due to a recent court decision interpreting provisions
of the Food Drug and Cosmetic Act ("FDCA"), as amended by
the Orphan Drug Act. (See "Top News" story above for
additional details.) Effective December 23,
2014.
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