The FDA issued a draft guidance for industry titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data. The guidance provides recommendations to sponsors for complying with the Federal Food, Drug and Cosmetic Act (FD&C Act) when submitting study data derived from real-world data sources in an applicable regulatory submission using standards specified in the Data Standards Catalog (Catalog).
Real-world data submitted as study data in new drug applications, abbreviated new drug applications, certain biologics license applications, and certain investigational new drugs are subject to the requirements in the FD&C Act and the guidance for industry titled Providing Regulatory Submissions in Electronic Format – Standardized Study Data (Study Data Guidance). Currently, the Study Data Guidance says the agency can process, review, and archive electronic submissions of clinical and nonclinical study data (including data derived from real-world data sources) that use the standards specified in the Catalog posted to FDA’s Study Data Standards Resources webpage. Accordingly, those submissions that contain study data derived from real-world data sources must be in electronic format using the study data standards currently supported by FDA as specified in the Catalog.
This draft guidance is part of a series of guidances FDA has already published, or plans to publish, as part of the agency’s Real-World Evidence Program and in support of the 21st Century Cures Act and the Prescription Drug User Fee Act.
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