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28 February 2018Americas

FDA introduces orphan drug pilot scheme

The US Food and Drug Administration (FDA) 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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More on this story

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4 October 2021 The US Court of Appeals for the Eleventh Circuit has found that the US Food and Drug Administration violated the exclusivity of a patent covering a drug for a rare autoimmune disorder, by approving the same treatment specifically for children.

FDA reveals further steps to encourage generic competition

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