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30 May 2024 - The US FDA plans to release a draft guidance this year on the use of artificial intelligence/machine ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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. ...

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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 ...

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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), ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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Draft methods (version 7.0): IQWiG is extending the comment period

26 January 2023 - The new deadline is 28 February 2023. ...

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