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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 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 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 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 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 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 ...
Posted by Michael Wonder on 19 Oct 2022
Advancing real world evidence program
19 October 2022 - As announced in the Federal Register notice published on 20 October 2022, the FDA is conducting an ...
Posted by Michael Wonder on 10 Oct 2022
High quality data to empower data-driven medicines regulation in the European Union
10 October 2022 - EMA and the Heads of Medicines Agencies in the EU Member States are moving ahead with ...
Posted by Michael Wonder on 13 Sep 2022
FDA finalises guidance on submitting RWD/RWE in application cover letters
13 September 2022 - To help better track submissions that include real world data and real world evidence, the US ...
Posted by Michael Wonder on 08 Sep 2022
Submitting documents using real world data and real world evidence to FDA for drug and biological products
8 September 2022 - To facilitate FDA’s internal tracking of submissions to the Agency that include real world data and real ...
Posted by Michael Wonder on 05 Sep 2022
Clinical trials: real world data plays early role in efforts to increase diversity
5 September 2022 - The use of real world data to help design clinical trials is nothing new but increasingly it ...
Posted by Michael Wonder on 31 Aug 2022
Reproducibility of real world evidence studies using clinical practice data to inform regulatory and coverage decisions
31 August 2022 - Studies that generate real world evidence on the effects of medical products through analysis of digital data ...