Blog
RSS FeedPosted by Michael Wonder on 01 Feb 2023
Changes applying to evaluation of new substances for listed medicines
1 February 2023 - The TGA has introduced Mandatory requirements for applications to vary the Permissible Ingredients Determination under section 26BD ...
Posted by Michael Wonder on 30 Jan 2023
Life sciences industry calls for better funding for medicine and technology regulator
31 January 2023 - The life sciences, health and medicine sectors have come together to call for improved funding of ...
Posted by Michael Wonder on 29 Jan 2023
COVID-19 vaccine safety report (27 January 2023)
27 January 2023 - Since the beginning of the vaccine rollout to 22 January 2023, almost 65 million doses of COVID-19 ...
Posted by Michael Wonder on 26 Jan 2023
Evolus receives regulatory approval for Nuceiva in Australia
23 January 2023 - Australia among the largest countries in the world for aesthetic neurotoxins. ...
Posted by Michael Wonder on 23 Jan 2023
TGA grants provisional approval to Pfizer’s COVID-19 bivalent (Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine) booster dose vaccine
23 January 2023 - On 20 January 2023, the TGA granted provisional approval to Pfizer’s bivalent COVID-19 vaccine: tozinameran and famtozinameran ...
Posted by Michael Wonder on 23 Jan 2023
TGA commences evaluation of Moderna COVID-19 vaccine (Spikevax) for potential transition to full registration
20 January 2023 - The TGA has commenced evaluation of an application from Moderna to transition its COVID-19 vaccine, Spikevax, ...
Posted by Michael Wonder on 16 Jan 2023
The game-changing plan to cut barriers to medical abortion
16 January 2023 - A push is under way to make medical abortion more accessible across Australia by cutting down ...
Posted by Michael Wonder on 13 Jan 2023
COVID-19 vaccine safety report (12 January 2023)
12 January 2023 - Since the beginning of the vaccine rollout to 8 January 2023, almost 65 million doses of COVID-19 ...
Posted by Michael Wonder on 22 Dec 2022
COVID-19 vaccine safety report (22 December 2022)
22 December 2022 - This is an abbreviated version of the COVID-19 vaccine safety report. ...
Posted by Michael Wonder on 20 Dec 2022
COVID-19 vaccine safety report (15 December 2022)
15 December 2022 - To 11 December 2022, the TGA has received 706 reports which have been assessed as likely to ...
Posted by Michael Wonder on 03 Dec 2022
COVID-19 vaccine safety report (1 December 2022)
1 December 2022 - To 27 November 2022, the TGA has received 709 reports which have been assessed as likely to ...
Posted by Michael Wonder on 28 Nov 2022
Croma Australia, a subsidiary of Hugel Aesthetics, receives TGA approval in Australia for Letybo (letibotulinumtoxinA) for the treatment of glabellar lines
28 November 2022 - Approval is supported by positive results from three completed Phase 3 trials that enrolled more than 1000 ...
Posted by Michael Wonder on 28 Nov 2022
An open letter to doctors from the TGA
28 November 2022 - The TGA welcomes feedback and is committed to continuously improving processes and communications. ...
Posted by Michael Wonder on 25 Nov 2022
Hugel's 'Letybo' first in Korea to obtain marketing approval from Australia
24 November 2022 - Obtained marketing approval on the 23rd (local time) from the TGA of Australia for the indication of ...
Posted by Michael Wonder on 19 Nov 2022
COVID-19 vaccine safety report (17 November 2022)
17 November 2022 - To 13 November 2022, the TGA has received 706 reports which have been assessed as likely to ...