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RSS FeedPosted by Michael Wonder on 15 Feb 2024
Launch of new HMA-EMA catalogues of real world data sources and studies
15 February 2024 - The EMA and the Heads of Medicines Agencies have launched two public electronic catalogues: one for ...
Posted by Michael Wonder on 22 Nov 2023
Updates to the HTA Review Research and Analysis papers collection: draft HTA expert paper published
22 November 2023 - The draft paper 'Optimising the availability and use of real world data and real world evidence to ...
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 28 Aug 2023
CADTH to establish industry task force on real world data for post market drug evaluations
18 August 2023 - CADTH is establishing an industry task force that will build upon the recently released guidance for reporting ...
Posted by Michael Wonder on 28 Jun 2023
Facilitating review of real world data studies: the oncology QCARD initiative
27 June 2023 - Expanding ways to generate evidence can lead to an array of benefits for medical product development, including ...
Posted by Michael Wonder on 25 Jun 2023
Use of real world evidence in regulatory decision making – EMA publishes review of its studies
23 June 2023 - Real world evidence from studies led by regulators can complement evidence from other sources including clinical trials. ...
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 23 May 2023
Health Canada’s position on the CADTH guidance for reporting RWE to support decision-making
18 May 2023 - Canada’s CADTH collaborated with Health Canada and other stakeholders to develop the guidance for reporting real world ...
Posted by Michael Wonder on 18 May 2023
Collaboration creates roadmap in Canada to report real world evidence studies
16 May 2023 - CADTH, Health Canada, and the Institut national d’excellence en santé et en services sociaux (INESSS) are ...
Posted by Michael Wonder on 27 Apr 2023
CADTH formalises offering on real-world evidence through its scientific advice program
25 April 2023 - During a 1-year learning period, CADTH expanded its Scientific Advice program to include advice on real-world evidence ...
Posted by Michael Wonder on 28 Mar 2023
DARWIN EU has completed its first studies and is calling for new data partners
28 March 2023 - DARWIN EU, the Data Analysis and Real World Interrogation Network, has accomplished its first year of establishment. ...
Posted by Michael Wonder on 05 Mar 2023
Replacing RCTs with real world data for regulatory decision-making: a self-fulfilling prophecy?
2 March 2023 - Real world data are advocated as an alternative approach to randomised clinical trials for closing knowledge gaps ...
Posted by Michael Wonder on 02 Mar 2023
Efficient RCTs with real world data for benefit assessments: accelerating evidence-based care
2 March 2023 - Together with colleagues from the Belgian HTA agency KCE, three employees of IQWiG in the BMJ are ...
Posted by Michael Wonder on 23 Dec 2022
FDA’s new real world evidence program offers early agency feedback
21 December 2022 - The US FDA is aiming to improve the quality of real world evidence used in regulatory ...
Posted by Michael Wonder on 23 Nov 2022
DARWIN EU welcomes first data partners
23 November 2022 - EMA has selected the first set of data partners to collaborate with DARWIN EU, the Data Analysis ...