Eleventh Circuit finds FDA fell foul of Orphan Drug Act

04-10-2021

Eleventh Circuit finds FDA fell foul of Orphan Drug Act

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The US Court of Appeals for the Eleventh Circuit has found that the US Food and Drug Administration (FDA) violated the exclusivity of a patent covering a drug for a rare autoimmune disorder, by approving the same treatment specifically for children.


Catalyst Pharmaceuticals, Food and Drug Administration, US Court of Appeals for the Eleventh Circuit, autoimmune, orphan drugs, Jacobus Pharmaceuticals

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