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RSS FeedPosted by Michael Wonder on 09 Jun 2021
Glaukos Announces Australia’s TGA regulatory approval for Preserflo MicroShunt
8 June 2021 - Glaukos Corporation today announced that the TGA has granted regulatory approval for the Preserflo MicroShunt intended for ...
Posted by Michael Wonder on 07 Jun 2021
Proposed refinements to the regulation of personalised medical devices
7 June 2021 - Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 ...
Posted by Michael Wonder on 07 Jun 2021
TGA investigating Pfizer jabs for children over 12
7 June 2021 - Australia’s medical regulator is considering allowing children over the age of 12 to be vaccinated with ...
Posted by Michael Wonder on 07 Jun 2021
New regulatory arrangements support businesses and health care professionals to communicate and incentivise COVID-19 vaccination
7 June 2021 - The TGA has implemented arrangements to facilitate the communication of information about approved COVID-19 vaccines. ...
Posted by Michael Wonder on 03 Jun 2021
COVID-19 vaccine weekly safety report (3 June 2021)
3 June 2021 - Eight additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 27 May 2021
COVID-19 vaccine weekly safety report (27 May 2021)
27 May 2021 - Nine additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 25 May 2021
TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine
24 May 2021 - Today, the TGA approved an application from Pfizer to change its current storage conditions for its ...
Posted by Michael Wonder on 24 May 2021
Gilead withdraws submission for Jyseleca
24 May 2021 - Decision should not come as a major surprise given FDA rejection last year. ...
Posted by Michael Wonder on 24 May 2021
ATAGI/THANZ statement provides further guidance for the AstraZeneca vaccine and narrows contra-indication
23 May 2021 - The Australian Technical Advisory Group on Immunisation and the Thrombosis and Haemostasis Society of Australia and New ...
Posted by Michael Wonder on 23 May 2021
Prescription medicines: applications under evaluation (May 2021 update)
21 May 2021 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 22 May 2021
US biotech Novavax could make COVID vaccine onshore in Australia
20 May 2021 - American biotechnology company Novavax has outlined plans to make doses of its coronavirus vaccine in Australia ...
Posted by Michael Wonder on 21 May 2021
TGA evaluating first monoclonal antibody treatment for COVID-19 sotrovimab - GlaxoSmithKline
21 May 2021 - The Therapeutic Goods Administration granted a provisional determination to GlaxoSmithKline in relation to the monoclonal antibody ...
Posted by Michael Wonder on 20 May 2021
Government calls for pitches for mRNA vaccine production facilities
21 May 2021 - Plans to build a new Australian vaccine facility will be launched on Friday in a call ...
Posted by Michael Wonder on 20 May 2021
COVID-19 vaccine weekly safety report
20 May 2021 - Six additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 19 May 2021
TGA considering changing storage rules of Pfizer jab, could allow Aussies to get dose at GPs or pharmacists: Hunt
20 May 2021 - Australians could get access to the Pfizer jab through GPs or pharmacists, on top of state-run ...