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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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14 September 2017 The Food and Drugs Administration has cleared the backlog of orphan drug designation requests, one month early.

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3 January 2018 The US Food and Drug Administration revealed additional steps aimed at encouraging generic competition today.

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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.

More on this story

FDA clears orphan drug backlog

14 September 2017 The Food and Drugs Administration has cleared the backlog of orphan drug designation requests, one month early.

FDA reveals further steps to encourage generic competition

3 January 2018 The US Food and Drug Administration revealed additional steps aimed at encouraging generic competition today.

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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.

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