Blog
RSS FeedPosted by Michael Wonder on 17 Mar 2017
Expedited pathways for prescription medicines
17 March 2017 - The TGA would like to thank respondents who provided submissions in response to the October 2016 ...
Posted by Michael Wonder on 16 Mar 2017
Nine submissions done and two due by month end…
16 March 2017 - Industry advocacy at AusBiotech is in ‘top gear’ with nine submissions completed on behalf of members ...
Posted by Michael Wonder on 08 Mar 2017
Donald Trump's FDA plans could affect drug regulation in Australia, leading medic warns
9 March 2017 - Drug safety and regulation in Australia are under threat from US President Donald Trump, says leading ...
Posted by Michael Wonder on 21 Feb 2017
AusBiotech suggests FSANZ amend cost recovery plan
21 February 2017 - AusBiotech has responded to Food Standards Australia New Zealand (FSANZ) call for comment on the draft ...
Posted by Michael Wonder on 15 Feb 2017
Proposed changes to accessing unapproved therapeutic goods through the Authorised Prescriber and Special Access Schemes
15 February 2017 - The TGA is seeking comments from interested parties on the proposed changes to the Special Access Scheme ...
Posted by Michael Wonder on 12 Feb 2017
TGA approval timelines for new cancer medicines
13 February 2017 - The publication of submission dates in the TGA's Annual Report for 2016 enables more insightful analysis ...
Posted by Michael Wonder on 06 Feb 2017
Greg Hunt's innovation fund sent back to drawing board
5 February 2017 - Former industry minister Greg Hunt's $500 million national innovation fund has been sent back to the ...
Posted by Michael Wonder on 01 Feb 2017
Diabetes drug that cuts sugar will also reduce heart problems
2 February 2017 - Diabetes will no longer be a death sentence for many sufferers, with a drug often prescribed ...
Posted by Michael Wonder on 31 Jan 2017
Trump health pick Tom Price pressed over purchase of shares in ASX-listed biotech Innate
31 January 2017 - US Republican politician Tom Price got a privileged offer to buy an Australian biomedical stock at ...
Posted by Michael Wonder on 31 Jan 2017
Registration of new chemical entities in Australia (2016)
31 January 2017 - The TGA has published its annual summary for 2016. ...
Posted by Michael Wonder on 10 Jan 2017
Australian approval for drug that 'melts' leukaemia
10 January 2017 - A new anti-cancer drug with the power to ‘melt away’ certain advanced forms of chronic lymphocytic ...
Posted by Michael Wonder on 03 Jan 2017
TGA rejects Fetzima
3 January 2016 - The TGA rejects the registration dossier for Pierre Fabre's serotonin noradrenaline reuptake inhibitor (SNRI). ...
Posted by Michael Wonder on 22 Dec 2016
TGA approves new lung cancer drug osimertinib for patients dealt cruel double blow
23 December 2016 - Elly Calabia doesn't talk about survival rates and life expectancy with her oncologist. ...
Posted by Michael Wonder on 20 Dec 2016
Productivity Commission’s report recommendations would hurt Australian innovation and delay access to breakthrough medicines
20 December 2016 - The Productivity Commission report recommendations, if adopted, would put local jobs, investment and Australian patients’ early ...
Posted by Michael Wonder on 20 Dec 2016
TGA approves new uses for Janssen's Imbruvica
20 December 2016 - The TGA has approved the use of ibrutinib for first-line use in patients with chronic lymphocytic ...