carmendorin / iStockphoto.com
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.
Already registered?
Login to your account
If you don't have a login or your access has expired, you will need to purchase a subscription to gain access to this article, including all our online content.
For more information on individual annual subscriptions for full paid access and corporate subscription options please contact us.
To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.
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
Americas
3 January 2018 The US Food and Drug Administration revealed additional steps aimed at encouraging generic competition today.
Americas
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
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.
Editor's picks
Editor's picks
Americas
3 January 2018 The US Food and Drug Administration revealed additional steps aimed at encouraging generic competition today.
Americas
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
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
3 January 2018 The US Food and Drug Administration revealed additional steps aimed at encouraging generic competition today.
Americas
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
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.