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USFDA Guidance: Pharmacogenomic Data Submissions

Earlier today (16 March 2023) the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and National Center for Toxicological Research (NCTR) released a draft guidance on "Pharmacogenomic Data Submissions" which will replace the 2005 guidance.

USFDA defines the term "Pharmacogenomics as the study of variations of DNA and RNA characteristics as related to drug response".


Pharmacogenomic studies can help identify factors that influence interindividual differences in drug exposure and response (both effectiveness and toxicity), allowing for individualized therapy.


Results of pharmaceutical genomic studies supporting the use of a genomic biomarker in planned clinical trials must be reported to the FDA with detailed information.


The draft guidance is intended to facilitate progress in pharmacogenomics and the use of pharmacogenomic data in drug development as well as clarify the contexts in which pharmacogenomic study findings and data must be included in applications for investigational new drugs (INDs), new drug applications (NDAs), and biologic license applications (BLAs) based on FDA regulations.


Moreover, this document provides recommendations for submitting pharmacogenomic data to sponsors and applicants.


To know more about the Contexts for When Pharmacogenomic Data Submissions Are Required and Recommended Reporting Levels click this LINK.

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