Subscribe
fda-1
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

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

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

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.


Editor's picks

Unified Patent Court
‘Be prepared, and don’t assume at the UPC’: Christopher Stothers
12 September 2024

Editor's picks

Unified Patent Court
‘Be prepared, and don’t assume at the UPC’: Christopher Stothers
12 September 2024
Americas
Litigation implications of the USPTO’s terminal disclaimer proposal
29 August 2024
Europe
UPC confirms validity of Edwards Lifesciences heart valve tech patent
23 July 2024
Europe
Labour govt appoints new Minister with IP oversight
9 July 2024
Americas
New-look WIPR Leaders 2024 is ‘most rigorous’ yet
2 July 2024
Americas
Earthquake Chevron: A massive shock to the system?
2 July 2024

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.

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.

More features

Gilead scores win in fake HIV drug dispute
Polsinelli grows roster with ex-corporate counsel
‘Don’t rely on national case law’ at the UPC: Wouter Pors, Bird & Bird
Sandoz wins $137.2m payout for lost profits in generic launch
Sanofi signs global rights deal to develop rare cancer therapy
Unified Patent Court visualised: Cases, divisions, and classes in charts
WBD to merge with firm to create ‘powerhouse’ practice
‘Be prepared, and don’t assume at the UPC’: Christopher Stothers