Ingredient name changes: a medicine ingredient by any other name…

11 June 2019 - Consistent names are important, especially the names we use for important things like medicine ingredients. ...

Read more →

FDA officials call for patient-friendly terminology in oncology

29 May 2019 - Officials from the US FDA's oncology offices say they plan to develop a glossary of patient-friendly ...

Read more →

Statement from FDA Commissioner on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

7 March 2019 - We’re at a critical point for the future of biosimilars in the U.S. Millions of American ...

Read more →

Diverging from FDA, Health Canada announces suffix-free biologic and biosimilar naming convention

18 February 2019 - Health Canada has announced that all biologics, including biosimilars, will be identified by their brand names and ...

Read more →

Mylan and Novartis to FDA: where are the suffixes?

26 September 2018 - Mylan and Novartis are taking issue with the fact that the US FDA has yet to ...

Read more →

White House proposes a narrowing of FDA’s mission — and a new name

21 June 2018 - The Trump administration has proposed a fundamental change to the mission of the FDA, one that ...

Read more →

Feds broaden the definition of ‘pharmacy’ in a bid to level playing field for startup

6 April 2018 - Across the US, upstart pharmacies are turning the prescription drug business on its head, offering digitally ...

Read more →

Biosimilar medicines regulation

22 February 2018 - This guidance assists sponsors of biosimilar medicines to complete an application to register their medicine on the ...

Read more →

International harmonisation of ingredient names – update on PBS changes

6 December 2017 - While some of the changes to active ingredient names have already appeared in the PBS Schedule, ...

Read more →

FDA begins adding suffixes to newly approved biologics' names

17 November 2017 - The US FDA this week began adding four-letter meaningless suffixes at the end of newly approved ...

Read more →

Will the FDA add suffixes to approved biologics' names?

20 October 2017 - Back in January, the US FDA finalised guidance on how biosimilars and their biologic reference products' ...

Read more →

Unlicensed and off-label uses of medicines: definitions and clarification of terminology

5 August 2017 - The terms “licensed”, “unlicensed”, and “off-label”, often used in relation to marketing and prescribing medicinal products, ...

Read more →

Nomenclature of biological medicines

28 July 2017 - The TGA is seeking comments from interested parties on proposed options on whether there is a need ...

Read more →

International harmonisation of ingredient names – PBS changes

3 May 2017 - Some active ingredient names used in Australia differ from those used internationally.  ...

Read more →

FDA finalises guidance on non-proprietary naming of biologics and biosimilars

12 January 2017 - In a departure from the way the WHO and Europe name biologics, the US FDA has ...

Read more →