Promoting flexibility and efficiency, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents in early July, addressing oversight of next generation sequencing (NGS)-based tests and the databases that support clinical claims for these tests. Acknowledging input from genomics experts, providers, patients and other industry stakeholders via public workshops and other efforts, Jeffrey…
FDA Workshops and Stakeholder Engagement Culminate in Draft Guidance on NGS-Based Testing
by Glenn S. Demby | Jul 14, 2016 | FDA-nir, National Lab Reporter