Blog
RSS FeedPosted by Michael Wonder on 21 Sep 2021
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 ...
Posted by Michael Wonder on 21 Sep 2021
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 ...
Posted by Michael Wonder on 21 Sep 2021
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 ...
Posted by Michael Wonder on 15 Sep 2021
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 ...
Posted by Michael Wonder on 13 Sep 2021
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 ...
Posted by Michael Wonder on 30 Aug 2021
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 ...
Posted by Michael Wonder on 24 Aug 2021
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. ...
Posted by Michael Wonder on 19 Aug 2021
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 ...
Posted by Michael Wonder on 13 Aug 2021
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 ...
Posted by Michael Wonder on 08 Aug 2021
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 ...
Posted by Michael Wonder on 04 Aug 2021
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 ...
Posted by Michael Wonder on 03 Aug 2021
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 ...
Posted by Michael Wonder on 02 Aug 2021
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 ...
Posted by Michael Wonder on 02 Aug 2021
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 ...
Posted by Michael Wonder on 31 Jul 2021
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 ...