Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 27 Mar 2023
Clinical trial considerations to support accelerated approval of oncology therapeutics
24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious ...
Posted by Michael Wonder on 27 Mar 2023
FDA outlines plan for digital health technologies for clinical trials
24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...
Posted by Michael Wonder on 08 Feb 2023
Stakeholders want more clarity on FDA's statistical approach to assessing bioequivalence
7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...
Posted by Michael Wonder on 26 Jan 2023
Draft methods (version 7.0): IQWiG is extending the comment period
26 January 2023 - The new deadline is 28 February 2023. ...
Posted by Michael Wonder on 24 Jan 2023
HAS updates its recommendations for the proper use of osteoporosis drugs
24 January 2023 - Osteoporosis is a disease whose first cause is ageing and which is characterised by the reduction ...