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# Comments on FDA Real-World Data Guidance
- URL: https://www.fdaweb.com/comments-on-fda-real-world-data-guidance/
- Published: 2021-11-30T12:00:00.000Z
- Updated: 2026-09-14T17:23:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150662

Amgen says it supports FDA issuance of a draft guidance, *Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision Making for Drug and Biological Products*, that gives sponsors, researchers, and other stakeholders considerations when proposing to use electronic health records or medical claims data in clinical studies to support a regulatory decision for safety or effectiveness. In a comment [letter](https://downloads.regulations.gov/FDA-2020-D-2307-0019/attachment%5F1.pdf?ref=fdaweb.com), Amgen asks that as FDA continues to develop the draft, it consider these points: 

- Amgen agrees with FDA’s encouragement for sponsors to seek early feedback from the agency on the proposed electronic health record or medical claims studies;
- Amgen agrees with the recommendations made throughout the guidance related to data quality during the data accrual, curation, and transformation process; and
- the guidance could more clearly outline ways to seek agreement with FDA on key variables requiring validation.

The letter also includes line-by-line specific comments.

In their [submission](https://downloads.regulations.gov/FDA-2020-D-2307-0016/attachment%5F1.pdf?ref=fdaweb.com), three physicians from the University of California San Francisco and Yale University say they applaud the FDA draft for its comprehensiveness and thoughtfulness in providing guidance about leveraging real-world data (RWD) to generate real-world evidence for drug and biological products. The doctors say they support several key provisions of the guidance and provide specific comments organized by section of the document.

Janssen [says](https://downloads.regulations.gov/FDA-2020-D-2307-0033/attachment%5F1.pdf?ref=fdaweb.com) the draft is “an important step in ensuring that all stakeholders involved in the real-world evidence ecosystem are aware of FDA’s expectations for real-world data.” The company says it appreciates the amount of detail provided in the draft. It asks the agency to consider mechanisms for stakeholders to provide feedback to FDA on the RWD guidance series once all the component documents have been issued. The company also provides comments on contributions of RWD stakeholders, meeting opportunities to support robust RWD studies, streamlining validation, external control arms, registration of RWD studies, data submission, and best practices for RWD analysis methods.

Otsuka [responded](https://downloads.regulations.gov/FDA-2020-D-2307-0012/attachment%5F1.pdf?ref=fdaweb.com) with specific line-by-line comments.