Blog
RSS FeedPosted by Michael Wonder on 03 Mar 2025
Canada’s Drug Agency publishes new guidance for rare disease registries in Canada
28 February 2025 - On Rare Disease Day — a global event dedicated to raising awareness for the millions of ...
Posted by Michael Wonder on 17 Jan 2025
International collaboration provides new guidance on the use of surrogate outcomes in cost effectiveness analysis
17 January 2025 - Recommendations will help organisations that evaluate new drugs establish whether their use will result in longer-term benefits ...
Posted by Michael Wonder on 13 Jan 2025
International collaboration provides new guidance on the use of surrogate endpoints in cost effectiveness analysis
9 January 2025 - Recommendations will help organisations that appraise new drugs establish whether their use will result in longer-term ...
Posted by Michael Wonder on 05 Dec 2024
Canada’s Drug Agency launches consultation on methods guide
28 November 2024 - Canada’s Drug Agency is launching a consultation on its first ever methods guide. ...
Posted by Michael Wonder on 31 May 2024
FDA plans to release AI drug development guidance this year
30 May 2024 - The US FDA plans to release a draft guidance this year on the use of artificial intelligence/machine ...
Posted by Michael Wonder on 04 Apr 2024
New model validation tool to support economic evaluations of health technologies
1 April 2024 - CADTH has developed a comprehensive and accessible tool to support the validation of economic models used in ...
Posted by Michael Wonder on 31 Oct 2023
NICE launches first modular update to its methods and processes
31 October 2023 - NICE’s methods and processes now include a proportionate approach to technology appraisals, and a new way of ...
Posted by Michael Wonder on 09 Oct 2023
The evolving nature of health technology assessment: a critical appraisal of NICE’s new methods manual
6 October 2023 - NICE recently completed a review of its methods for health technology assessment, involving a 2 stage ...
Posted by Michael Wonder on 19 Sep 2023
How IQWiG assesses – version 7.0 of the method paper comes into force
19 September 2023 - Fundamental revision of the cost benefit assessment and addition of the concept of application-accompanying data collection. ...
Posted by Michael Wonder on 30 Aug 2023
FDA issues final guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
30 August 2023 - Today, the US FDA issued a final guidance for industry titled Considerations for the Use of Real-World ...
Posted by Michael Wonder on 27 Jun 2023
NICE launches public consultation on updates to health technology evaluations manual
27 June 2023 - A public consultation on updates to NICE’s health technology evaluations manual is now open. ...
Posted by Michael Wonder on 05 Jun 2023
ICER proposes updates to value assessment framework methods and procedures
5 June 2023 - Proposed updates reflect experience with current framework, benchmarking with other health technology assessment groups, and external stakeholder ...
Posted by Michael Wonder on 05 Jun 2023
Guidance for reporting real world evidence
31 May 2023 - CADTH has partnered with Health Canada, the Institut national d’excellence en santé et en services sociaux (INESSS), ...
Posted by Michael Wonder on 27 May 2023
Adjusting for covariates in randomized clinical trials for drugs and biological products
26 May 2023 - This final guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomised ...
Posted by Michael Wonder on 18 May 2023
Guidance for industry to prevent and mitigate medicine shortages
17 May 2023 - EMA has published recommendations for industry on good practices to ensure continuity in the supply of ...