Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic

20 June 2022 - Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global ...

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Target trial emulation for transparent and robust estimation of treatment effects for health technology assessment using real world data: opportunities and challenges

25 May 2022 - Evidence about the relative effects of new treatments is typically collected in randomised controlled trials.  ...

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CADTH expands scientific advice program to include advice on real world evidence

28 April 2022 - CADTH is expanding its scientific advice program to include applications for advice on real world evidence generation ...

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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 ...

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ISPOR launches “About Real-World Evidence” content

8 March 2022 - Introductory information is designed to make RWE more accessible for health care audiences. ...

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Industry cites outdated standards as flaw in FDA’s real world data draft guidance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 ...

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Initiation of DARWIN EU Coordination Centre advances integration of real world evidence into assessment of medicines in the EU

9 February 2022 - EMA is initiating today the establishment of the Coordination Centre for the Data Analysis and Real ...

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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 ...

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FDA issues draft guidance for industry, considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products

9 December 2021 - The U.S. FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data ...

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FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products

29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...

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A vision for use of real world evidence in EU medicines regulation

24 November 2021 - Enabling the use of real world evidence and establishing its value for regulatory decision-making on the development, ...

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Review of real world evidence and patient reported outcomes

24 November 2021 - The TGA recently commissioned a review into its usage of real world evidence and patient reported ...

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FDA acknowledges hurdles in utilising real world data

28 October 2021 - FDA is seeking to address the added complexities for incorporating real-world data and real-world evidence into ...

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FDA issues draft guidance for industry on data standards for drug and biological product submissions containing real world data

21 October 2021 - Today, the U.S. FDA issued a draft guidance for industry titled Data Standards for Drug and Biological ...

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Aetion and NICE announce collaboration to explore use of real world evidence for comparative effectiveness studies to inform clinical guidance

6 October 2021 - Collaboration will leverage the Aetion Evidence Platform to study when and how real world evidence can support ...

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