FDA Releases Draft Guidance for Creating FDA-Approved Public Genomic Databases

August 8, 2016

By: Linda A. Malek and Allyson M. Beach

On July 8, 2016, as part of its role in President Obama’s Precision Medicine Initiative, the Food & Drug Administration (FDA) released draft guidance “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics” as part of its focus on oversight of NGS-based tests for germline diseases and other disorders.  The draft guidance is open for public comment until October 6, 2016

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