USA – FDA issues guidance on submission of pharmacogenomic data

The US Food and Drug Administration (FDA) has issued draft guidance to clarify which pharmacogenomic study findings and data should be included in regulatory submissions for investigational new drug applications (INDs), new drug applications (NDAs) and biologics license applications (BLAs).

The guidance, issued on 16 March 2023, also provides recommendations to sponsors on the format and level of detail for reporting pharmacogenomic data submissions, which will vary based on how the genomic biomarkers are used and the potential risks. When finalized, this new guidance will replace final guidance for industry that FDA published in 2005.

“Sponsors and applicants submitting or holding INDs, NDAs, or BLAs are subject to FDA requirements for submitting data to the FDA that are relevant to drug safety and effectiveness. However, the regulations were developed before the advent of widespread animal or human genetic testing (e.g., high-throughput DNA sequencing) or gene expression testing and do not specifically describe the submission requirements for such data as a separate category,” FDA wrote in the draft guidance…