Blog
RSS FeedPosted by Michael Wonder on 18 Jan 2022
TGA in review (2021)
19 January 2022 - Using a liberal definition of what constitutes a 'new medicine', we have determined the TGA approved ...
Posted by Michael Wonder on 17 Jan 2022
TGA approves ‘game changing’ ovarian cancer drug bringing new hope to patients
18 January 2022 - Federal health authorities have approved a breakthrough drug for ovarian cancer, bringing a game-changing treatment option ...
Posted by Michael Wonder on 17 Jan 2022
TGA recognises the Gamaleya Institute vaccine (Sputnik V, Russian Federation) for international travel to Australia
17 January 2022 - Today, the TGA determined that an additional COVID-19 vaccine, the two dose course of the Gamaleya ...
Posted by Michael Wonder on 14 Dec 2021
Access Consortium statement on COVID-19 medicines
14 December 2021 - Vaccines have played a critical role in fighting the COVID-19 pandemic. However, medicines can still play ...
Posted by Michael Wonder on 08 Dec 2021
Improvements to clinical trials will strengthen Australia’s economy and benefit patients
8 December 2021 - Clinical trials in Australia need improvements if we are to increase our global competitiveness says Medicines ...
Posted by Michael Wonder on 24 Nov 2021
COVID-19 vaccine indemnity
24 November 2021 - The Australian Government is reducing the claim threshold of the no fault COVID-19 Vaccine Claims Scheme to ...
Posted by Michael Wonder on 24 Nov 2021
Review of real world evidence and patient reported outcomes
24 November 2021 - The TGA recently commissioned a review into its usage of real world evidence and patient reported ...
Posted by Michael Wonder on 09 Nov 2021
Australia to wait for data from US children before clearing vaccine here
10 November 2021 - Australia’s top immunisation advisers will wait on safety data from at least several hundred thousand young ...
Posted by Michael Wonder on 30 Sep 2021
Medicines industry continues to protect Australians from medicine shortages
30 September 2021 - ACCC extends approval for ongoing collaboration ...
Posted by Michael Wonder on 29 Sep 2021
Data protection scheme for assessed listed medicines
29 September 2021 - The TGA has implemented a data protection scheme for assessed listed medicines. ...
Posted by Michael Wonder on 22 Sep 2021
TGA approves Leqvio
22 September 2021 - Inclisiran is a cholesterol lowering double-stranded small interfering ribonucleic acid. ...
Posted by Michael Wonder on 13 Sep 2021
Joint statement of support for an Australian Patent Box
13 September 2021 - Australia’s health innovators support the introduction of a Patent Box, and we welcome this initiative by the ...
Posted by Michael Wonder on 12 Aug 2021
Reclassification of software based medical devices
12 August 2021 - Recent changes to regulation of software based medical devices came into effect in early 2021, which ...
Posted by Michael Wonder on 11 Aug 2021
New Alzheimer's drug aducanumab is dividing doctors and patients, as the TGA weighs up its risk-benefit profile
12 August 2021 - After a decades-long career as a biology teacher, John Rodgers applies the strict logic of a ...
Posted by Michael Wonder on 09 Aug 2021
COVID-19 vaccine: international collaboration
6 August 2021 - The Therapeutic Goods Administration has strong working relationships with a wide range of international agencies and ...