Blog
RSS FeedPosted by Michael Wonder on 01 Jul 2016
TGA fees and charges from 1 July 2016
1 July 2016 - The TGA has published a summary of fees and charges, which are in the Australian therapeutic goods ...
Posted by Michael Wonder on 29 Jun 2016
Prescription medicines: pre-submission pilot
29 June 2016 - The TGA is introducing pilot changes to the pre-submission phase of the prescription medicines registration process. ...
Posted by Michael Wonder on 28 Jun 2016
TGA publishes AusPAR for Proshaeos (alprostadil)
28 June 2016 - The TGA has published an AusPAR for Montrose Pharma's Proshaeos (alprostadil). ...
Posted by Michael Wonder on 20 Jun 2016
TGA approves new indication for Glypressin (terlipressin acetate)
20 June 2016 - The TGA has approved a new indication for Ferring Pharmaceuticals' Glypressin (terlipressin acetate). ...
Posted by Michael Wonder on 17 Jun 2016
TGA publishes AusPAR for simoctocog alfa rhu (Nuwiq)
17 June 2016 - The TGA has published an AusPAR for Octapharma's Nuwiq (simoctocog alfa). ...
Posted by Michael Wonder on 15 Jun 2016
Hepatitis C sufferers’ ire at activist-website ban
14 June 2016 - A website which raises awareness about a medical cure for hepatitis C could be hidden from Australians. ...
Posted by Michael Wonder on 15 Jun 2016
$4.5 million behind new pill to tackle Australia’s number one killer
15 June 2016 - A new pill designed to reduce the devastating toll of heart disease and stroke in Australia and ...
Posted by Michael Wonder on 09 Jun 2016
TGA publishes AusPAR for Nuvigil (armodafinil)
9 June 2016 - The TGA has published an AusPAR for Teva's Nuvigil (armodafinil). ...
Posted by Michael Wonder on 06 Jun 2016
TGA publishes 2 new AusPARs
6 June 2016 - The TGA has published AusPARs for talimogene laherparepvec (Imlygic) & naloxegol oxalate (Movantik). ...
Posted by Michael Wonder on 02 Jun 2016
TGA approves lesinurad (Zurampic)
2 June 2016 - The TGA has approved Astra Zeneca's lesinurad (Zurampic). ...
Posted by Michael Wonder on 01 Jun 2016
TGA approves new indication for Perjeta
1 June 2016 - The TGA has approved a new use for Roche's Perjeta (pertuzumab). ...
Posted by Michael Wonder on 26 May 2016
Prescription medicines: TGA annual report for 2015 (part 3 - timelines)
26 May 2016 - The TGA claims it takes, on average, 12 months for the agency to register a new ...
Posted by Michael Wonder on 26 May 2016
TGA updates prescription medicine clinical units
26 May 2016 - The TGA conducts a minor reallocation of prescription medicine authorisation unit work streams. ...
Posted by Michael Wonder on 23 May 2016
Prescription medicines: TGA annual report for 2015
23 May 2016 - The report notes submission dates; a TGA first. ...
Posted by Michael Wonder on 20 May 2016
TGA approves idarucizumab (Praxbind)
20 May 2016 - The TGA approved idarucizumab (Praxbind) on 11 May 2016. ...