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BioWorld - Thursday, April 18, 2024
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» 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
No Comments
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
.
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Orphan drug