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Zdrowie i gospodarka · 22.08.2016

Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests; Public Workshop; Request for Comments

The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests." The purpose of this workshop is to obtain feedback on two FDA draft guidances, "Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases" and "Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics" that describes new approaches to regulate NGS-based tests.

Source: Federal Register — Food and Drug AdministrationOpen original release →