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# Stakeholder Comments on Real-World Data Guidance
- URL: https://www.fdaweb.com/stakeholder-comments-on-real-world-data-guidance/
- Published: 2022-03-01T12:00:00.000Z
- Updated: 2026-09-14T17:34:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151263

IQVIA says it appreciates the FDA effort to provide guidance on the use of registry data to support regulatory decision-making for drug and biological products and the agency’s conceptual approach to defining multiple key terms. The firm’s 2/25 [letter](https://www.regulations.gov/comment/FDA-2021-D-1146-0011?ref=fdaweb.com) commented on an FDA draft guidance, *Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products*. IQVIA provides comments and recommendations about data standardization and terminology, along with line-by-line specific comments.

The [comment](https://www.regulations.gov/comment/FDA-2021-D-1146-0024?ref=fdaweb.com) submitted by the Real-World Evidence Alliance commends FDA for issuing the guidance and says it agrees with the agency’s recognition that registry data can be useful in regulatory decision-making. The alliance says it advocates for policies that will **(1)** advance FDA’s real-world evidence (RWE) framework; **(2)** encourage the use of RWE to better understand treatment effects in underrepresented populations; **(3)** enhance opportunities for RWE organizations to consult with the agency, and **(4)** increase communication on generation and use of RWE.

The Biotechnology Innovation Organization [offers](https://www.regulations.gov/comment/FDA-2021-D-1146-0022?ref=fdaweb.com) “overarching comments” on collaborating with registry holders/partners, the scope of the guidance (types of registries), and harmonization of RWE guidance. It also provides specific line-by-line comments.