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# Comments Sought on Pharmacogenomic Data Guidance
- URL: https://www.fdaweb.com/comments-sought-on-pharmacogenomic-data-guidance/
- Published: 2017-06-19T12:00:00.000Z
- Updated: 2026-09-14T22:30:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138966

*Federal Register* notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry on Pharmacogenomic Data Submissions; OMB Control Number 0910–0557.” The guidance provides recommendations to sponsors submitting or holding INDs, NDAs, or BLAs on what pharmacogenomic data should be submitted during the drug development process. It distinguishes between pharmacogenomic tests that may be considered valid biomarkers appropriate for regulatory decisionmaking, and other, less well-developed exploratory tests. The submission of exploratory pharmacogenomic data is not required under the regulations, although the agency encourages the voluntary submission of such data. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-06-19/pdf/2017-12604.pdf?ref=fdaweb.com).