FDA clears orphan drug backlog

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

Already registered?

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk

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

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.

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.

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

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.

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

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.