FDA issues final guidance on data standards for drug and biological product submissions containing real-world data

New US FDA final guidance for industry on ‘Data Standards for Drug and Biological Product Submissions Containing Real-World Data’ covers challenges and resources for applying currently supported data standards to real-world data sources.

At the close of 2023, the FDA issued a cluster of final guidance documents, featuring two regarding use of real-world data (RWD) and real-world evidence (RWE) for regulatory decision-making. One of these, entitled ‘Data Standards for Drug and Biological Product Submissions Containing Real-World Data: Guidance for Industry’, presents the FDA’s current thinking on challenges to using currently supported data standards for RWD sources and details available FDA resources on the use of data standards for submitted trial data.

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View our infographic timeline of recent FDA draft and final guidance:
Infographic: Milestones in the FDA’s Real-World Evidence activities

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This new guidance is a finalization of the draft guidance of the same title that was issued in October 2021, updated to incorporate consideration of comments received on the draft version. The FDA announced the availability of the final guidance in the US Government Federal Register on December 22, 2023.

Changes from the draft to the final guidance include clarification of FDA’s understanding of considerations and challenges when using currently supported data standards for RWD sources. The guidance subdivides these into:

• Challenges in RWD standardization
• Documentation of processes for managing RWD
• Considerations for conforming RWD to currently supported FDA study data standards
• Considerations for mapping RWD to study data submission standards
• Considerations for data transformations

Additional updates include elaboration of available FDA resources for consultation about the use of data standards for study data submitted to FDA, plus editorial changes to improve clarity, such as movement of concepts from glossary entries or footnotes into the main document text.

The guidance is part of a series of documents developed under the FDA RWE Framework and Program that was initiated in 2018. It provides recommendations to sponsors to help support compliance with the Federal Food, Drug, and Cosmetic Act when submitting study data derived from RWD sources in applicable regulatory submissions using standards specified in the Data Standards Catalog.

FDA encourages sponsors to discuss their planned approaches with FDA early on:
“Sponsors should discuss, as early as possible, with the appropriate FDA review division, any planned submission of study data derived from RWD sources in an applicable submission.”