U.S. Food and Drug Administration reasoning in approval decisions when efficacy evidence is borderline (2013–2018)

21 September 2021 - The U.S. FDA has substantial flexibility in its approval criteria in the context of life-threatening disease and ...

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Covid-19 delta outbreak: major PHARMAC review report delayed by lockdown

22 September 2021 - Act says it is "not good enough" an interim report for a much touted independent PHARMAC ...

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EU-HTA regulation: methodical preparations for implementation start with IQWiG and G-BA

21 September 2021 - The institute and the G-BA are part of a consortium that is developing the methodological basis ...

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Final report on the Australian Government response to the recommendations of the Senate Community Affairs References Committee Report

15 September 2021 - The Government acknowledges the efforts and actions detailed in this progress report to implement the Senate ...

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Medicare Benefits Schedule continuous review to improve patient care

13 September 2021 - Medicare items and services will be reviewed by experts on an on-going basis to ensure the Medicare ...

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Review of the National Medicines Policy – call for submissions

30 August 2021 - The National Medicines Policy Review Committee is now welcoming submissions to support the review of the National Medicines ...

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Method paper: IQWiG puts draft version 6.1 up for discussion

23 August 2021 - The IQWiG has presented the draft for the next version of its General Methods.  ...

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NICE’s health technology assessment methods and processes to be evaluated

19 August 2021 - NICE has launched a public consultation on proposed changes to the way it develops recommendations across ...

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Congress should fix FDA’s accelerated approval program for the next 30 years

12 August 2021 - The FDA's approval of the Alzheimer’s drug Aduhelm has sparked a broader debate on the merits ...

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US tropical disease priority review vouchers: lessons in promoting drug development and access

6 August 2021 - The COVID-19 global pandemic has devastated lives and economies. It has served as a reminder of how ...

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FDA regulation and approval of medical devices: 1976-2020

3 August 2021 - US law generally requires testing of high-risk medical devices prior to approval, as well as pre-market evaluation ...

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National Medicines Policy Review Committee and Terms of Reference

3 August 2021 - The National Medicines Policy has influenced a number of important strategies, frameworks and programs developed since ...

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FDA’s Pazdur challenges attack on accelerated approval program

2 August 2021 - In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill ...

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National Medicines Policy Review will be significant for all Australians

30 July 2021 - Medicines Australia is eager to be part of a significant moment in history for Australian health ...

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FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway

30 July 2021 - Criticisms of the US FDA’s accelerated approval process have resurfaced after the recent approval of aducanumab ...

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