- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Devices and Radiological HealthCenter 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.
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:
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.