Blog
RSS FeedPosted by Michael Wonder on 12 Feb 2020
Australia's biotech innovations heading offshore, prompting calls for greater funding to bring them to market
11 February 2020 - The demand on the health sector has never been more evident, as the world scrambles to ...
Posted by Michael Wonder on 20 Jan 2020
Fees and charges proposal 2020-21
20 January 2020 - The TGA is undertaking a consultation through its website to seek stakeholder's views on TGA’s proposed fees ...
Posted by Michael Wonder on 20 Jan 2020
New science strategy prepares regulatory scientists for the future
20 January 2020 - The Health Products Regulation Group in the Department of Health has published a new regulatory science ...
Posted by Michael Wonder on 14 Jan 2020
TGA - 2019 in review
14 January 2020 - According to the TGA, it approved 34 new chemical entities in 2019. ...
Posted by Michael Wonder on 03 Dec 2019
EpiPen Jr
2 December 2019 - Due to the critical nature of the ongoing EpiPen Jr shortage, the TGA is allowing one ...
Posted by Michael Wonder on 25 Nov 2019
Acalabrutinib receives TGA approval for CLL and SLL cancers
25 November 2019 - The Therapeutic Goods Administration has approved the use of acalabrutinib (Calquence) for the treatment of patients ...
Posted by Michael Wonder on 21 Nov 2019
FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia
21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...
Posted by Michael Wonder on 11 Nov 2019
TGA approved terminology for therapeutic goods
11 November 2019 - The Therapeutic Goods Administration develops and maintains approved terminology to ensure the accuracy and consistency of ...
Posted by Michael Wonder on 24 Oct 2019
Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation
24 October 2019 - The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed new ...
Posted by Michael Wonder on 21 Oct 2019
Annual performance statistics report: July 2018 to June 2019
21 October 2019 - At 30 June 2019 there were 88,788 therapeutic goods on the ARTG, including 31,987 new products added ...
Posted by Michael Wonder on 14 Oct 2019
STA to market sarcoma drug in Australia, New Zealand and SE Asia following license deal
14 October 2019 - Specialised Therapeutics now filing for TGA approval. ...
Posted by Michael Wonder on 25 Sep 2019
TGA approves drug to fight ovarian cancer
26 September 2019 - Some women diagnosed with ovarian cancer could have their survival rates significantly increased after the Therapeutic ...
Posted by Michael Wonder on 17 Sep 2019
Provisional approval of lenvatinib in combination with pembrolizumab for the treatment of advanced endometrial carcinoma
18 September 2019 - The Therapeutic Goods Administration has provisionally approved the use of lenvatinib (Lenvima) in combination with pembrolizumab ...
Posted by Michael Wonder on 03 Sep 2019
The TGA launches new tool to help sponsors find information on registering prescription medicines
3 September 2019 - Today the Therapeutic Goods Administration launched a new tool to assist users with finding information within ...
Posted by Michael Wonder on 28 Aug 2019
Australian Public Assessment Reports for prescription medicines
28 August 2019 - TGA is reviewing the operation of transparency measures and are considering activities to increase transparency of ...