Regulation of software based medical devices

15 January 2021 - The TGA has updated its guidance on the regulation of software as a medical device. ...

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Push for Australia to develop a world-leading coronavirus vaccine

13 January 2021 - Australia could take the lead in a worldwide quest to find a long-term solution to COVID-19, ...

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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 ...

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'Digital contraceptive' gets approval by Australian health authorities

15 December 2020 - A smartphone app can officially be used as a contraceptive tool by Australians after becoming the ...

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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 ...

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Australia secures 20 million extra Astra Zeneca vaccines

11 December 2020 - Australia secures 20 million extra Astra Zeneca vaccines for onshore manufacturing to cover entire population and a ...

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CSL, University of Queensland coronavirus vaccine trials halted

11 December 2020 - CSL and University of Queensland researchers knew of the potential for false HIV positives in the ...

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Australian COVID vaccine terminated due to HIV ‘false positives’

11 December 2020 - A billion-dollar deal for the Morrison government to buy more than 50 million doses of the ...

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Telix granted TGA priority review for prostate cancer imaging

7 December 2020 -  Telix announces today that the Company’s preliminary application to the TGA for TLX591-CDx was made at ...

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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 ...

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Australia 'ahead of schedule' on COVID-19 vaccine plan

3 December 2020 - Australia could approve a COVID-19 vaccine almost two months ahead of schedule, the head of the ...

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What the UK's COVID-19 vaccine means for Australia

2 December 2020 - The race for a COVID-19 vaccine appears to have hit the final stretch, with the UK ...

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COVID-19: Australia on track for Pfizer vaccine in March

2 December 2020 - Health Minister Greg Hunt says the UK’s approval of the Pfizer vaccine, to be rolled out from ...

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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 ...

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TGA announces approval of new medicine from ASX listed company

26 November 2020 - Afamelanotide acetate (Scenesse) was approved on 22 October 2020. ...

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