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14 September 2017Americas

FDA clears orphan drug backlog

The Food and Drugs Administration (FDA) has cleared the backlog of orphan drug designation requests, one month early.

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Americas
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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More on this story

Americas
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.
Americas
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.
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.

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