Blog
RSS FeedPosted by Michael Wonder on 07 Mar 2026
FDA official offers insights on agency’s criteria for real world data in regulatory submissions
6 March 2026 - The US FDA will consider several factors when determining whether to accept real world data and ...
Posted by Michael Wonder on 17 Dec 2025
FDA eliminates major barrier to using real world evidence in drug and device application reviews
15 December 2025 - The US FDA today removed a key limitation on the use of real world evidence used in ...
Posted by Michael Wonder on 28 Nov 2025
Utilisation of real world evidence in regulatory approvals for multiple myeloma therapies
27 November 2025 - Multiple myeloma is a rare, incurable haematologic malignancy that demands ongoing innovation in treatment approaches given frequent ...
Posted by Michael Wonder on 24 Sep 2025
FDA use of real world evidence in regulatory decision-making
22 September 2025 - The FDA has a long history of using real world data and real-world evidence to monitor and ...
Posted by Michael Wonder on 16 Sep 2025
The use of real world evidence among health care payers: a scoping review
12 September 2025 - Real world evidence is increasingly used to assess and make regulatory decisions on health technologies. However, its ...
Posted by Michael Wonder on 27 Apr 2025
The role and value of real-world evidence in health technology decision-making in France, Germany, Italy, Spain, and the UK: insights on external control arms
22 April 2025 - Real-world evidence is increasingly used and accepted by health technology assessment (HTA) bodies as supportive evidence ...
Posted by Michael Wonder on 03 Apr 2025
Real-world evidence to support health technology assessment and payer decision making: is it now or never?
31 March 2025 - The aim of this policy article is twofold: (i) to provide a summary and update of recent ...
Posted by Michael Wonder on 01 Feb 2025
The use of real world data for estimating relative treatment effects in NICE health technology assessment submissions: a review
1 February 2025 - This paper investigates the current use of real world data for estimating relative treatment effects in NICE ...
Posted by Michael Wonder on 13 Dec 2024
CDER establishes new Center for Real World Evidence Innovation
12 December 2024 - Today, the US FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center ...
Posted by Michael Wonder on 09 Aug 2024
Canada’s Drug Agency taking steps to expand access to real world evidence
7 August 2024 - Canada’s Drug Agency has published a summary report from its time-limited Industry Task Force. ...
Posted by Michael Wonder on 01 Jul 2024
Real world evidence submissions to the Center for Biologics Evaluation and Research
26 June 2024 - As part of the reauthorisation of the Prescription Drug User Fee Act (PDUFA VII), FDA committed ...
Posted by Michael Wonder on 23 May 2024
COTA announces extended collaboration with FDA to advance the use of real world data in cancer research
22 May 2024 - Today, COTA announced an extension of its research collaboration with the US FDA Oncology Center of Excellence. ...
Posted by Michael Wonder on 16 May 2024
Acceptability of using real world data to estimate relative treatment effects in health technology assessments: barriers and future steps
15 May 2024 - Evidence about the comparative effects of new treatments is typically collected in randomised controlled trials (RCTs). In ...
Posted 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 ...