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# BIO Recommendations for RWD Guidance
- URL: https://www.fdaweb.com/bio-recommendations-for-rwd-guidance/
- Published: 2022-02-08T12:00:00.000Z
- Updated: 2026-09-14T17:31:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151110

The Biotechnology Innovation Organization (BIO) has submitted [comments](https://downloads.regulations.gov/FDA-2021-D-0548-0028/attachment%5F1.pdf?ref=fdaweb.com) on an FDA draft guidance, *Data Standards for Drug and Biological Product Submissions Containing Real-World Data*, listing four “overarching recommendations to improve the draft guidance.” The recommendations are: 

- considerations for prospective and retrospective real-world data (RWD);
- considerations for mapping and transforming RWD;
- considerations for regulatory flexibility for data standardization; and
- harmonization of RWD/E (real-world data/real-world evidence) guidance.

BIO also provides line-by-line technical comments and recommendations.