Spotlight: Real-World Evidence Guidance

Real-World Evidence Guidance
Welcome to The Evidence Base Spotlight on ‘Real-World Evidence Guidance’.

Guidance and recommendations for the conduct and analysis of real-world evidence (RWE) studies to ensure they are of high quality and can be used to inform healthcare decision-making. Read selected coverage from The Evidence Base.

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Featured content

Infographic: Global landscape for RWD and RWE initiatives in regulatory decision making

The global landscape for RWD and RWE initiatives in regulatory decision making is rapidly evolving. In this infographic, we’ve pulled together the various initiatives from around the globe, from the latest EMA report on the use of RWE in regulatory decision-making, to the FDA’s RWE Program and the NMPA guidances from China, to provide our readers with an at-a-glance overview of the field.

Infographic: Milestones in the FDA’s Real-World Evidence activities

This infographic charts the history of the FDA’s RWE activities since 2016 and is intended to help our readers navigate the landscape of the various FDA resources and guidelines.

 

 

FDA real-world evidence guidance Aug 2023FDA final guidance for industry on use of real-world data and real-world evidence to support regulatory decision-making

The guidance, entitled, ‘Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products’, reflects the agency’s current thinking about the use of real-world evidence in regulatory decision-making.

 

FDA case studies using real-world evidenceCase studies of FDA recently approved product applications using real-world evidence: an interview with Jie Li, Gerald Dal Pan and John Concato, FDA

Since the passing of the 21st Century Cures Act in 2016, the FDA has made significant progress towards the use of RWE to support regulatory decision-making. In this interview, Jie Li, Gerald Dal Pan and John Concato from the FDA discuss the learnings from several case studies where product approvals have been supported with RWE.

 

FDA issues latest RWD/RWE draft guidance on the use of externally controlled trials

The new draft guidance released by the FDA provides recommendations to sponsors and researchers who are seeking to use externally controlled trials to generate evidence on the safety and effectiveness of a drug product.

 

 

CRDSA roundtable analysis and recommendations from the public feedback on the FDA draft external controls guidance

CRDSA has recently issued a report developed from its July roundtable discussion of the public feedback received on the FDA draft guidance on externally controlled trials. Here we summarize the key findings from the report.

 

FDA advances real-world evidence in regulatory decision-making with new draft guidance on non-interventional studies

A new US FDA draft guidance provides advice for industry on ‘Data Standards for Drug and Biological Product Submissions Containing Real-World Data’, looking to include evidence from non-interventional studies to support the effectiveness or safety of a drug for regulatory purposes.

 

FDA guidance on registries for RWDFDA finalizes guidance on using registries to generate real-world data for regulatory decision-making

The FDA has released its finalized guidance for industry titled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.” Published on December 22, 2023, this guidance is part of the FDA’s RWE Program, fulfilling the Federal Food, Drug, and Cosmetic Act’s mandate under section 505F to provide guidance on using RWE for regulatory decisions.

 

Stakeholders comment on FDA draft real-world evidence guidance for medical devices

In seeking to advance the use of RWE in regulatory decision-making for medical devices, in December 2023 the FDA released a new draft guidance, ‘Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices’. The guidance aims to build on the previous FDA guidance issued in August 2017 and satisfies the requirements of the Food and Drug Omnibus Reform Act of 2022 (FDORA) as well as meeting the commitments set out in the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V).

Chasing the holy grail of using real-world evidence in regulatory decision-making for medical devices: an interview with Paul Coplan, Johnson & Johnson

In this interview, we speak with Paul Coplan (Vice President and Head of MedTech Epidemiology & Real-World Data Sciences, Johnson & Johnson) to learn more about the role of RWE and its emerging use to support medical device regulatory decisions.

 

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