Blog
RSS FeedPosted by Michael Wonder on 10 Mar 2021
Australia’s Therapeutic Goods Administration approves Feraccru to treat iron deficiency with or without anaemia in adults
9 March 2021 - Shield Therapeutics notes that Australia’s Therapeutic Goods Administration has registered Feraccru in the Australian Register of ...
Posted by Michael Wonder on 10 Mar 2021
TGA approves Zolgensma
10 March 2021 - Onasemnogene abeparvovec is a new gene therapy for children with spinal muscular atrophy. ...
Posted by Michael Wonder on 05 Mar 2021
TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variant
5 March 2021 - TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from ...
Posted by Michael Wonder on 24 Feb 2021
TGA reviewing COVID-19 tests to rule out issues diagnosing variants
24 February 2021 - Adjunct Professor John Skerritt has tasked the nation’s medical regulator with ensuring COVID-19 tests are successfully ...
Posted by Michael Wonder on 19 Feb 2021
Clinical decision support software
18 February 2021 - From 25 February 2021, the way that software-based medical devices are regulated in Australia will change. ...
Posted by Michael Wonder on 16 Feb 2021
Medicines Australia statement on TGA’s provisional approval of AstraZeneca’s COVID-19 vaccine
16 February 2021 - Medicines Australia welcomes the TGA’s decision granting provisional approval of the AstraZeneca/Oxford University COVID-19 vaccine, marking ...
Posted by Michael Wonder on 16 Feb 2021
TGA provisionally approves AstraZeneca's COVID-19 vaccine
16 February 2021 - The Therapeutic Goods Administration has granted provisional approval to AstraZeneca for its COVID-19 vaccine, making it ...
Posted by Michael Wonder on 15 Feb 2021
TGA approves new formulation of glatiramer acetate
16 February 2021 - The TGA thinks glatiramer acetate (Glatopa) is a new chemical entity. ...
Posted by Michael Wonder on 15 Feb 2021
One billion dollar bid to go it alone with COVID-19 vaccine hub
15 February 2021 - A proposal for a state-of-the-art $1 billion facility to manufacture vaccines and prescription drugs in Australia ...
Posted by Michael Wonder on 11 Feb 2021
COVID-19 vaccine shipment could arrive in Australia as early as next week
11 February 2021 - Coronavirus vaccines are a step closer to arriving in Australia after the European Commission formally approved ...
Posted by Michael Wonder on 11 Feb 2021
CSL confident it can make vaccine to cover variants, if needed
11 February 2021 - CSL is confident it can make an updated version of AstraZeneca’s COVID-19 vaccine to cover any ...
Posted by Michael Wonder on 09 Feb 2021
Pfizer vaccine bound for Australia won’t be blocked
9 February 2021 - Europe will not delay the first doses of Pfizer vaccine bound for Australia despite moves to block ...
Posted by Michael Wonder on 08 Feb 2021
COVID-19 vaccine certificates to be available online within days of immunisation
8 February 2021 - Australians will have access to their COVID-19 immunisation certificates within days of receiving the vaccine, with ...
Posted by Michael Wonder on 08 Feb 2021
TGA one of only five non-European regulators invited to participate on European committees on COVID-19 vaccines and therapeutics
8 February 2021 - Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate ...
Posted by Michael Wonder on 04 Feb 2021
Repurposing of prescription medicines
4 February 2021 - The Therapeutic Goods Administration is conducting a public consultation that seeks to understand potential obstacles and ...