Blog
RSS FeedPosted 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 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 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 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 ...
Posted by Michael Wonder on 10 Aug 2022
Real-world data can help expedite drug approvals for serious diseases with few options
10 August 2022 - My grandmother was diagnosed with dementia in the early 2000s. We started taking it seriously when she ...
Posted by Michael Wonder on 03 Aug 2022
Connecting electronic health records to clinical trials: how to embrace the promise of real world data
3 August 2022 - We all know that real world data from electronic health records could boost clinical trial efficiency ...
Posted by Michael Wonder on 20 Jul 2022
Simulating colorectal cancer trials using real world data
20 July 2022 - Using real world data –based trial simulation approach, we aim to simulate colorectal cancer trials and ...
Posted by Michael Wonder on 05 May 2022
Real world evidence - where are we now?
4 May 2022 - Notwithstanding on-going confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 ...
Posted by Michael Wonder on 12 Feb 2022
Industry cites outdated standards as flaw in FDA’s real world data draft guidance
11 February 2022 - The US FDA should adopt updated data standards that accommodate the “evolving and emerging” nature of ...
Posted by Michael Wonder on 01 Feb 2022
CDER explores series of draft guidances on real world data, real world evidence - drug information update
31 January 2022 - Collection and analysis of real world data continue to gain traction in the biomedical community, accompanied by ...
Posted by Michael Wonder on 09 Dec 2021
FDA issues draft guidance for industry, considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
9 December 2021 - The U.S. FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data ...