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GUIDANCE DOCUMENT

E18 Genomic Sampling and Management of Genomic Data Guidance for Industry March 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2016-D-1255
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-1255.

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