Blog
RSS FeedPosted by Michael Wonder on 22 Mar 2023
Advancing regulatory science in the EU – mid-point report published
22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...
Posted by Michael Wonder on 14 Sep 2022
Independent review of paracetamol overdose
14 September 2022 - The TGA has published an independent expert report examining the incidence of serious injury and death ...
Posted by Michael Wonder on 17 Mar 2022
COVID-19 vaccine weekly safety report (17 March 2022)
17 March 2022 - To 13 March 2022, the TGA has received 457 reports which have been assessed as likely to ...
Posted by Michael Wonder on 15 Feb 2022
Office of Generic Drugs 2021 Annual Report
14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...
Posted by Michael Wonder on 14 Jan 2022
Advancing health through innovation: new drug therapy approvals 2021
13 January 2022 - The FDA’s Center for Drug Evaluation and Research has issued its report, Advancing Health Through Innovation: New ...
Posted by Michael Wonder on 19 Aug 2021
TGA reduces timeframe for publishing adverse event reports
19 August 2021 - With strong public interest in adverse event reports relating to COVID-19 vaccinations, and improvements in our ...
Posted by Michael Wonder on 08 Jul 2021
COVID-19 vaccine weekly safety report (8 July 2021)
8 July 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 27 May 2021
COVID-19 vaccine weekly safety report (27 May 2021)
27 May 2021 - Nine additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 20 May 2021
COVID-19 vaccine weekly safety report
20 May 2021 - Six additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 22 Apr 2021
TGA publishes AusPAR for Zolgensma
22 April 2021 - Rapid publication following approval. ...
Posted by Michael Wonder on 17 Dec 2020
FDA updates list of off-patent, off-exclusivity drugs without an approved generic
17 December 2020 - Today, the U.S. FDA published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved ...
Posted by Michael Wonder on 21 Jul 2020
TGA publishes AusPAR for Vemlidy
21 July 2020 - AusPAR published within days of its provisional registration; why do other take years? ...
Posted by Michael Wonder on 06 May 2020
Half yearly performance snapshot: July to December 2019
6 May 2020 - The TGA prepares an annual TGA Business Plan, which identifies the priority activities being undertaken over the ...
Posted by Michael Wonder on 05 May 2020
EMA publishes minutes of joint meeting with EUnetHTA - November 2019
5 May 2020 - This was the 18th meeting between the EMA and representatives from the EUnetHTA and attended by the ...
Posted by Michael Wonder on 20 Feb 2020
Serving public health paramount in a successful 2019 for FDA’s generic drug program
19 February 2020 - Safe, effective, high-quality generic drugs play a vital role in the U.S. health care system. ...