FDA Announces Availability of the Guidance, “E18 Genomic Sampling and Management of Genomic Data”

On March 2, 2018, the U.S. Food and Drug Administration (FDA) announced the availability of the final guidance for industry entitled “E18 Genomic Sampling and Management of Genomic Data”. The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. FDA finalized the guidance after carefully reviewing comments received on the draft guidance with the same name published in June 2016. The final guidance contains the same basic principles from the draft guidance, and includes revisions to the guideline to address comments received and to provide greater clarity.  

The guidance provides guidelines for genomic sampling and management of genomic data from interventional and non-interventional clinical studies. Awareness of, and interest in, genomic data obtained from clinical studies are growing. In particular, genomic research could be used in all phases of drug development to assess genomic correlates of drug response, and to understand mechanisms of disease or drug pharmacology. The identification of genomic biomarkers underlying variability in drug response may be valuable to optimize patient therapy, design more efficient studies, and inform drug labeling. Furthermore, the generation and interpretation of genomic data, both within and across clinical studies and drug development programs, allow for a better understanding of pharmacological and pathological mechanisms and enable the identification of new drug targets.

This guidance focuses on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data in clinical studies. The guidance is intended to provide harmonized principles of genomic sampling and of management of genomic data in clinical studies to foster interactions amongst stakeholders, including drug developers, investigators, and regulators; and to encourage genomic research within clinical studies.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The “E18 Genomic Sampling and Management of Genomic Data” guidance is available at https://go.usa.gov/xnzBY. Please refer to the guidance for more details.

Instructions for submitting either electronic or written comments on Agency guidances at any time may be found in the federal register notice for this guidance (https://go.usa.gov/xnujv).