Blog
RSS FeedPosted by Michael Wonder on 20 Jan 2020
Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study
17 January 2020 - Failure to report the results of a clinical trial can distort the evidence base for clinical practice, ...
Posted by Michael Wonder on 09 Jan 2020
Human medicines: highlights of 2019
9 January 2020 - EMA has published a review of its key recommendations in 2019 on the authorisation and safety ...
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 29 Aug 2019
Academics and consumer groups protest FDA plan to summarise review documents
29 August 2019 - A Food and Drug Administration proposal to substitute detailed reviews of new drugs written by specific ...
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 ...
Posted by Michael Wonder on 17 Jan 2019
FDA is urged to mandate disclosure of clinical trial summaries as pilot program stalls
16 January 2019 - One year after the FDA launched a voluntary pilot program to release clinical study reports, which ...
Posted by Michael Wonder on 17 Apr 2018
Final minutes of December 2017 EMA/EUnetHTA meeting
16 April 2018 - The EMA has published the final minutes from the 15 December 2017 meeting. ...
Posted by Michael Wonder on 03 Apr 2018
Half yearly performance snapshot: July to December 2017
3 April 2018 - The TGA has maintained a high level of activity while also progressing regulatory reforms over the reporting ...
Posted by Michael Wonder on 30 Jan 2018
Prescription medicines and biologicals: TGA annual summary 2017
30 January 2018 - This is TGA's fourth annual summary report on the registration of prescription medicines, which includes new generic ...
Posted by Michael Wonder on 02 Oct 2017
Statement from FDA Commissioner Scott Gottlieb on the FDA’s adverse event reporting system and new search tool
2 October 2017 - The FDA’s adverse event reporting system is a database that contains adverse event reports, medication error reports ...
Posted by Michael Wonder on 26 Apr 2017
EMA publishes withdrawal assessment report for Graspa
25 April 2017 - On 14 November 2016, Erytech Pharma officially notified the CHMP that it wishes to withdraw its application ...
Posted by Michael Wonder on 20 Feb 2017
The European Medicines Agency and publication of clinical study reports: a challenge for the US FDA
20 February 2017 - The US FDA has been the standard of drug regulation worldwide for decades. ...
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 17 Jan 2017
Human medicines: highlights of 2016
17 January 2017 - 81 medicines recommended for approval, including 27 new active substances. ...
Posted by Michael Wonder on 06 Jan 2017
2016 financial year report from the Director
5 January 2017 - This letter is the Director's first annual report to various stakeholders. It summarises what Center have ...