TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran

24 June 2021 - Today, the Therapeutic Goods Administration granted provisional determination to Moderna Australia in relation to the COVID-19 ...

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Fees and charges: summary from 1 July 2021

23 June 2021 - The TGA is required to recover its costs for all activities that fall within the scope of ...

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TGA approves first generic pomalidomide

23 June 2021 - The TGA has approved first generic version of Celgene's Pomalyst. ...

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Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium

22 June 2021 - The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of ...

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COVID-19 delta strain requires two vaccine doses for protection, Therapeutic Goods Administration boss says

22 June 2021 - Australians will need two doses of a COVID-19 vaccine to adequately protect themselves against the highly ...

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Statement in response to latest ATAGI advice regarding COVID-19 vaccines

17 June 2021 - A statement from the Professor Paul Kelly, Australian Government Chief Medical Officer in response to the latest ...

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COVID-19 vaccine weekly safety report (17 June 2021)

17 June 2021 - Twelve additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...

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COVID-19 vaccine weekly safety report (10 June 2021)

10 June 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with ...

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ATAGI update following weekly COVID-19 meeting – 9 June 2021

10 June 2021 - An update from the Australian Technical Advisory Group on Immunisation following their weekly meeting on 9 June ...

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New Alzheimer’s drug unlikely to be approved in Australia soon, say experts

9 June 2021 - A controversial new drug that has offered hope to Alzheimer’s sufferers by slowing cognitive decline still ...

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Australia tipped to approve Pfizer vaccine for children this year

9 June 2021 - Infectious diseases paediatricians and vaccine experts anticipate the Pfizer shot could be approved for use in ...

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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 ...

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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 ...

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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 ...

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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.  ...

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