Blog
RSS FeedPosted by Michael Wonder on 18 Mar 2021
AstraZeneca ChAdOx1-S COVID-19
18 March 2021 - The TGA is closely reviewing reports of anaphylaxis after four cases were reported following the AstraZeneca ChAdOx1-S ...
Posted by Michael Wonder on 16 Mar 2021
ATAGI statement in response to European decisions about the AstraZeneca vaccine
16 March 2021 - ATAGI notes the suspension of the AstraZeneca vaccine program in several European countries due to reports ...
Posted by Michael Wonder on 16 Mar 2021
Doctors complain of ‘gag’ over AstraZeneca vaccine
16 March 2021 - High-profile doctors have complained they are being gagged from speaking out about their concerns on the ...
Posted by Michael Wonder on 14 Mar 2021
Approval of updated storage conditions for the Pfizer COVID-19 vaccine
13 March 2021 - The TGA has received and assessed additional data submitted by Pfizer for their COVID-19 vaccine (COMIRNATY - ...
Posted by Michael Wonder on 13 Mar 2021
COVID-19 vaccines - safety and effectiveness in older adults
10 March 2021 - Data on real-world use of COVID-19 vaccines approved in Australia provides reassurance about their safety in ...
Posted 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
New legislation to support medicine substitutions
5 March 2021 - New legislation has been passed to allow pharmacists to substitute a different medicine when a patient's ...
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 23 Feb 2021
TGA bans Pfizer, AstraZeneca brand mentions in COVID-19 vaccine advertising
24 February 2021 - Pharmacies, GPs and healthcare organisations will be banned from displaying advertisements identifying whether they are using ...
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. ...