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Home » D.C. Circuit: Once an orphan, always an orphan – at least in the past
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D.C. Circuit: Once an orphan, always an orphan – at least in the past

Aug. 18, 2020
By Mari Serebrov
The FDA’s bright line between orphan designation and exclusivity was erased, again, Monday for some drugs when the U.S. Court of Appeals for the District of Columbia denied the agency an en banc rehearing of Eagle Pharmaceuticals Inc. v. Alex Azar.
BioWorld Regulatory U.S. Orphan drug

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