Blog
RSS FeedPosted by Michael Wonder on 17 Aug 2021
Final terms of reference and public consultation to the post-market review of opiate dependence treatment program medicines
17 August 2021 - The public consultation process for the post-market review of opiate dependence treatment program medicines is now ...
Posted by Michael Wonder on 05 Jul 2021
Medical devices reforms: enhancements to post-market monitoring
5 July 2021 - This project has been established to enhance the adverse event reporting processes. ...
Posted by Michael Wonder on 22 Jun 2021
FDA 'may require' post-marketing studies to analyse long-term effects of breast cancer drugs
21 June 2021 - The US FDA "may require” or seek agreement from sponsors to conduct post-marketing studies to analyse ...
Posted by Michael Wonder on 07 Jun 2021
Post-market review of medicines for smoking cessation – public consultation on the draft report
7 June 2021 - The draft report for the post-market review of medicines for smoking cessation is available for public comment ...
Posted by Michael Wonder on 28 May 2021
Post-market review of opiate dependence treatment program medicines
28 May 2021 - On 24 March 2021 it was announced the Department of Health will conduct a post-market review ...
Posted by Michael Wonder on 24 Mar 2021
Post-market review of medicines available on the PBS Opiate Dependence Treatment Program
24 March 2021 - The Department of Health will conduct a post-market review of the medicines available under the Pharmaceutical ...
Posted by Michael Wonder on 15 Feb 2021
Post-market review of medicines for smoking cessation – stakeholder forum outcome
15 February 2021 - A stakeholder forum was held for the post-market review of medicines for smoking cessation via webinar on ...
Posted by Michael Wonder on 21 Dec 2020
Closure of the post-market review of the use of biologics in the treatment of severe chronic plaque psoriasis
21 December 2020 - A plain language summary for the post-market review of the use of biologics in the treatment ...
Posted by Michael Wonder on 09 Nov 2020
Post-market review of medicines for smoking cessation – targeted stakeholder forum
9 November 2020 - A Stakeholder Forum will be held via webinar for the post-market review of medicines for smoking cessation ...
Posted by Michael Wonder on 25 May 2020
Final report for the post-market review of pulmonary arterial hypertension medicines
25 May 2020 - The final report and outcomes of the post-market review of pulmonary arterial hypertension medicines are now publicly ...
Posted by Michael Wonder on 13 Mar 2020
Final terms of reference and public consultation to the post-market review of medicines for smoking cessation
13 March 2020 - The final terms of reference of the post-market review of medicines for smoking cessation are now ...
Posted by Michael Wonder on 24 Oct 2019
Post-market review of medicines for smoking cessation
24 October 2019 - A public consultation process for the post-market review of medicines for smoking cessation will be open ...
Posted by Michael Wonder on 10 Sep 2019
Why do post-marketing drug studies required by the FDA take so long?
10 September 2019 - Often times when a new drug is approved by the FDA, the agency requires more studies be ...
Posted by Michael Wonder on 13 Jun 2019
Review of Rotarix
12 June 2019 - TLV has decided to initiate a review of the drug Rotarix due to the Government's decision ...
Posted by Michael Wonder on 16 Nov 2018
Statement by FDA Commissioner Scott Gottlieb on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
16 November 2018 - The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As ...