FDA E18 Genomic Sampling and Management of Genomic Data Guidance for Industry
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E18 Genomic Sampling and Management of Genomic Data Guidance for Industry[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。标准截图
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E18 Genomic Sampling and Management of Genomic Data 1
Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. 2
I. INTRODUCTION (1) A. Objectives of the Guidance (1.1) The main objective of this guidance is to provide harmonized principles of genomic sampling and management of genomic data in clinical studies. This guidance will facilitate the implementation of genomic studies by enabling a common understanding of critical parameters for the unbiased collection, storage, and optimal use of genomic samples and data. This 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. This guidance is intended to foster interactions among 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 use of the word should in Agency guidances means that something is suggested or recommended, but not required. B. Background (1.2) Awareness of, and interest in, genomic data obtained from clinical studies are growing. In 1
This guidance was developed within the Expert Working Group (Efficacy) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been endorsed by the ICH Assembly at Step 4 of the ICH process, September 2017. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the ICH regions. 2
Arabic numbers reflect the organizational breakdown in the document endorsed by the ICH Assembly at Step 4 of the ICH process, September 2017.
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