FDA issues draft guidance for industry, considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products

9 December 2021 - The U.S. FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data ...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FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products

29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...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FDA issues draft guidance for industry on data standards for drug and biological product submissions containing real world data

21 October 2021 - Today, the U.S. FDA issued a draft guidance for industry titled Data Standards for Drug and Biological ...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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FDA, sponsors advance reliance on real world data & evidence

2 October 2021 - Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional ...

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EMA study reveals need for RWE framework, submission structure

14 September 2021 - The EMA has identified a need for more consistency in how real world evidence is submitted. ...

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Real world outcomes associated with new cancer medicines approved by the FDA and EMA: a retrospective cohort study

August 2021 - Real world data studies are increasingly used to support regulatory approvals, reimbursement decisions, and changes in clinical practice ...

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ICER uses observational real world evidence to update 2018 assessment on therapies for hereditary angioedema, finds therapies far less cost effective than earlier estimates

24 August 2021 - Patients initiating therapy in real world dataset had less frequent baseline attack rates than rates from clinical ...

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‘We don’t unlearn’: what the pandemic has taught regulators about real world data

11 August 2021 - During the pandemic, regulatory agencies deployed emergency measures left and right to speed care to patients. ...

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From Our Perspective: FDA approval demonstrates the role of real world evidence in regulatory decision-making on drug effectiveness

4 August 2021 - In this CDER From Our Perspective, experts discuss the recent FDA approval of Prograf (tacrolimus) in combination ...

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Fit for purpose real world data assessments in oncology: a call for cross stakeholder collaboration

21 July 2021 - Real world evidence remains a promising frontier in evidence generation to support improved health related patient outcomes. ...

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FDA approves new use of transplant drug based on real world evidence

16 July 2021 - Today, the U.S. Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a ...

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