Blog
RSS FeedPosted by Michael Wonder on 16 Mar 2026
EMA proposes new paper on proof of concept studies for paediatric oncology drugs
13 March 2026 - The EMA has released a concept paper proposing a future reflection paper on the development of ...
Posted by Michael Wonder on 26 Feb 2026
Clinical equivalence and non-inferiority within health technology assessment
23 February 2026 - Non-inferiority and clinical equivalence clinical trials can be used to determine whether a health technology is no ...
Posted by Michael Wonder on 24 Feb 2026
FDA launches framework for accelerating development of individualised therapies for ultra-rare diseases
23 February 2026 - The U.S. FDA today issued draft guidance for sponsors seeking approval for targeted individualised therapies by ...
Posted by Michael Wonder on 23 Jan 2026
Minimal residual disease and complete response in multiple myeloma: use as outcomes to support accelerated approval
20 January 2026 - This guidance provides recommendations to sponsors about using minimal residual disease and complete response in multiple myeloma ...
Posted by Michael Wonder on 16 Jan 2026
Guiding principles of good AI practice in drug development
14 January 2026 - The CDER and CBER have collaborated with the EMA to develop 10 guiding principles that industry ...
Posted by Michael Wonder on 16 Jan 2026
FDA issues guidance on modernising statistical methods for clinical trials
12 January 2026 - The US FDA today published draft guidance designed to facilitate the use of Bayesian methodologies in ...
Posted by Michael Wonder on 20 Dec 2025
The IQWiG methods: new version is effective immediately
19 December 2025 - With the General Methods 8.0, the new IQWiG methodology for determining minimum staffing levels for service ...
Posted by Michael Wonder on 15 May 2025
Health inequalities - an update to NICE’s methods for health technology evaluation
14 May 2025 - Our new modular update focuses on how we consider health inequalities when evaluating technologies for use in ...
Posted 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 ...