Blog
RSS FeedPosted by Michael Wonder on 01 Feb 2021
When is a medicine currently under review by the TGA not under evaluation?
1 February 2021 - The approval of the first new medicine for 2021 raises an interesting question. ...
Posted by Michael Wonder on 24 Jan 2021
TGA provisionally approves Pfizer COVID-19 vaccine
25 January 2021 - The Therapeutic Goods Administration has granted provisional approval to Pfizer Australia for its COVID-19 vaccine, Comirnaty, ...
Posted by Michael Wonder on 24 Jan 2021
TGA to give Australians confidence to get the COVID-19 jab
22 January 2021 - COVID-19 vaccines will play a major role in fighting the coronavirus pandemic. ...
Posted by Michael Wonder on 20 Jan 2021
TGA grants additional provisional determination for a COVID-19 vaccine
20 January 2021 - The TGA, part of the Department of Health, has granted a provisional determination to Biocelect (on ...
Posted by Michael Wonder on 19 Jan 2021
New labelling for antibiotics in Australia
19 January 2021 - The Pharmaceutical Society of Australia is to be applauded for changing the way pharmacists label the antibiotics ...
Posted by Michael Wonder on 18 Jan 2021
Norwegian investigation of COVID-19 vaccination risks for elderly, very frail patients
17 January 2021 - In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals ...
Posted by Michael Wonder on 15 Jan 2021
Regulation of software based medical devices
15 January 2021 - The TGA has updated its guidance on the regulation of software as a medical device. ...
Posted by Michael Wonder on 04 Jan 2021
TGA still waiting for 'further data' on AstraZeneca vaccine
4 January 2020 - Concerns over new coronavirus cases in Sydney and Melbourne look unlikely to prompt an accelerated approval ...
Posted by Michael Wonder on 15 Dec 2020
Over-the-counter access to low dose cannabidiol
15 December 2020 - Today the Therapeutic Goods Administration announced a final decision to down-schedule certain low dose cannabidiol preparations ...
Posted by Michael Wonder on 04 Dec 2020
Access Consortium statement on COVID-19 vaccines evidence
4 December 2020 - The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the ...
Posted by Michael Wonder on 02 Dec 2020
TGA statement on UK government emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech
2 December 2020 - The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer ...
Posted by Michael Wonder on 18 Nov 2020
TGA grants third provisional determination for a COVID-19 vaccine
18 November 2020 - On 16 November 2020 the TGA granted a provisional determination to Janssen Cilag in relation to ...
Posted by Michael Wonder on 12 Nov 2020
Coronavirus: vaccine rollout for five million Aussies tipped for March
11 November 2020 - The regulator of medicines in Australia has confirmed it expects to be able to approve the ...
Posted by Michael Wonder on 11 Nov 2020
Therapeutic Goods Administration gives green light for early Pfizer vaccine
11 November 2020 - The nation’s medicines regulator has paved the way for an early release of Pfizer’s breakthrough COVID-19 ...
Posted by Michael Wonder on 06 Nov 2020
Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme
6 November 2020 - The TGA has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical ...