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FDA announce the guidance for industry entitled “E18 Genomic Sampling and Management of Genomic Data.”

 

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a 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.

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.

The announcement of the guidance is published in the Federal Register on March 2, 2018.

In recent years, regulatory authorities and industry associations from around the world have participated in many important initiatives to promote international harmonization of regulatory requirements under the ICH. FDA has participated in several ICH meetings designed to enhance harmonization and FDA is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development.

The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. The ICH Assembly is responsible for the endorsement of draft guidelines and adoption of final guidelines. FDA publishes ICH guidelines as FDA guidance.

The guidance provides guidance on genomic sampling and management of genomic data from interventional and non-interventional clinical studies. The guidance addresses use of genomic samples and data irrespective of the timing of analyses and both prespecified and non-prespecified use.

The focus is on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data, within the scope of an informed consent policy or practice. The technical aspects of genomic sampling are also discussed when appropriate, recognizing the rapidly evolving technological advances in genomic sampling and data generation.

The guidance also intends to increase awareness and provide a reminder regarding subjects' privacy, protection of the data generated, the need to obtain suitable informed consent, and the need to consider transparency of findings in line with local legislation and regulations.

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