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 ...

Read more →

Medical devices reforms: enhancements to post-market monitoring

5 July 2021 - This project has been established to enhance the adverse event reporting processes. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

Review of Rotarix

12 June 2019 - TLV has decided to initiate a review of the drug Rotarix due to the Government's decision ...

Read more →

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 ...

Read more →