Blog
RSS FeedPosted by Michael Wonder on 08 Mar 2023
The unique device identifier: a unique opportunity
7 March 2023 - A unique device identifier is an individualised alphanumeric signature associated with a single medical device. Since 2013, ...
Posted by Michael Wonder on 05 Oct 2021
FDA’s naming rule for biosimilars has undermined Congress and health care
4 October 2021 - I recently tried to order white blood cell growth factor (pegfilgrastim) biosimilar for one of my ...
Posted by Michael Wonder on 11 Nov 2019
TGA approved terminology for therapeutic goods
11 November 2019 - The Therapeutic Goods Administration develops and maintains approved terminology to ensure the accuracy and consistency of ...
Posted by Michael Wonder on 26 Sep 2019
Change of name of liposomal medicines at high risk of medication errors
26 September 2019 - Marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit a variation ...
Posted by Michael Wonder on 31 Jul 2019
Names of liposomal medicines to be changed to avoid medication errors
31 July 2019 - All marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit to ...
Posted by Michael Wonder on 29 Jul 2019
Platelet rich plasma treatment is not classified as a drug, Health Canada says
27 July 2019 - Agency clarifies its position on controversial treatment made popular by superstar athletes. ...
Posted by Michael Wonder on 24 Jul 2019
FDA seeks input on biomarker, endpoint glossary
24 July 2019 - Two-and-a-half years after its release, the US FDA is asking for input from the public on ...
Posted by Michael Wonder on 11 Jun 2019
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. ...
Posted by Michael Wonder on 29 May 2019
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 ...
Posted by Michael Wonder on 07 Mar 2019
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 ...
Posted by Michael Wonder on 20 Feb 2019
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 ...
Posted by Michael Wonder on 26 Sep 2018
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 ...
Posted by Michael Wonder on 21 Jun 2018
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 ...
Posted by Michael Wonder on 22 Feb 2018
Biosimilar medicines regulation
22 February 2018 - This guidance assists sponsors of biosimilar medicines to complete an application to register their medicine on the ...
Posted by Michael Wonder on 19 Nov 2017
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 ...