Eleventh Circuit finds FDA fell foul of Orphan Drug Act

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.

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House passes Biden-backed orphan drug reform

23 May 2021 The US House of Representatives has passed a bill to amend exclusivity laws for drugs on the US Food and Drug Administration’s orphan drugs list.

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FDA introduces orphan drug pilot scheme

28 February 2018 The US Food and Drug Administration has introduced a pilot scheme for processing orphan designation requests more efficiently, as part of its commitment to support and expedite the development of rare disease products.

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Big Pharma

House passes Biden-backed orphan drug reform

23 May 2021 The US House of Representatives has passed a bill to amend exclusivity laws for drugs on the US Food and Drug Administration’s orphan drugs list.

Americas

FDA introduces orphan drug pilot scheme

More on this story

Big Pharma

House passes Biden-backed orphan drug reform

23 May 2021 The US House of Representatives has passed a bill to amend exclusivity laws for drugs on the US Food and Drug Administration’s orphan drugs list.

Americas

FDA introduces orphan drug pilot scheme