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Resistance Or Defiance The FDA And The 11th Circuit Spar Over Statute On Orphan Drug Statutory Exclusivity

Last September, the 11th Circuit Court of Appeals sided with a challenge to the FDA’s long-standing interpretation of the Orphan Drug Act by.

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Recent US Court Decision Threatens Orphan Exclusivity And Marketing Approval For Certain Orphan Drugs - Food, Drugs, Healthcare, Life Sciences

In yet another high profile loss for the Food and Drug Administration (FDA or Agency) in a challenge to the Agency's interpretation of the Orphan Drug Act (ODA), the Eleventh Circuit's decision.

United statesJacobus ruzurgiNdas blasSupreme courtJacobus pharmaceutical company incCatalyst pharmaceuticals incCatalyst pharms incCatalyst pharmaceuticalsPharms incOrphan drug actEleventh circuitJacobus pharmaceutical companyCatalyst pharmaceuticalsFederal foodCosmetic actRecent us court decision threatens orphan exclusivity and marketing approval for certain drugs

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