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# Suggestions for Pharmacogenomic Data
- URL: https://www.fdaweb.com/suggestions-for-pharmacogenomic-data/
- Published: 2023-06-22T12:00:00.000Z
- Updated: 2026-09-14T18:40:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154750

Novartis says it welcomes FDA efforts to draft a guidance for pharmacogenomics (PGx) work and submission in the context of drug development. The company’s comment [letter](https://www.regulations.gov/comment/FDA-2022-D-2856-0007?ref=fdaweb.com) says the guidance as drafted “would significantly influence the way we report exploratory pharmacogenomic research.” It asks for further FDA guidance on the categories of genomics findings that would enable the adoption of suitable standards. It also recommends that submissions require the addition of a standard PGx information summary detailing the PGx information expected within the submission.

In its [comment](https://www.regulations.gov/comment/FDA-2022-D-2856-0011?ref=fdaweb.com), Regeneron offers a possible framework for the submission of exploratory PGx studies for review by FDA. It suggests categorizing PGx studies into two broad categories for consideration for data submissions.

Takeda [says](https://www.regulations.gov/comment/FDA-2022-D-2856-0010?ref=fdaweb.com) the draft assumes that high dimensional biomarker analysis will use hypothesis testing. It recommends updating specific text lines to acknowledge the need to include multiplicity corrections or overfitting control, as appropriate, and to allow for other types of analyses beyond traditional hypothesis testing in pharmacogenomic submissions.

GlaxoSmithKline [says](https://www.regulations.gov/comment/FDA-2022-D-2856-0008?ref=fdaweb.com) it welcomes the draft guidance that has been written to facilitate progress in pharmacogenomics and update reporting requirements for submission of pharmacogenomic study findings.

Finally, the Personalized Medicine Coalition [applauds](https://www.regulations.gov/comment/FDA-2022-D-2856-0009?ref=fdaweb.com) FDA for updating its guidance so stakeholders can better understand and navigate data submissions to the agency in the modern technological landscape. “We believe the new draft guidance helps clarify when and how to submit required PGx data in INDs, NDAs, and BLAs, as well as FDA’s expectations regarding the format for reporting of this data,” it says. “However, to facilitate clearer and more consistent labeling for new products with PGx implications, we encourage FDA to more thoroughly standardize the placement of PGx information within submissions and standardize the types and categories of metabolic PGx information to be submitted.”