Blog
RSS FeedPosted 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 06 Dec 2019
Proposed changes to research and development tax incentive will discourage investment and undermine innovation
6 December 2019 - Medicines Australia is disappointed that proposed changes to the Research and Development Tax Incentive were tabled ...
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 26 Nov 2019
'Outrageous': banned breast implant maker flouts TGA and safety concerns
25 November 2019 - The Therapeutic Goods Administration is demanding answers from the manufacturer of a banned breast implant after ...
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 02 Oct 2019
Progressing the long-term plan for stem cell research
2 October 2019 - This is the next step in the $150 million Stem Cell Therapies Mission, helping world-class Australian researchers ...
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 ...