FDA Workshops and Stakeholder Engagement Culminate in Draft Guidance on NGS-Based Testing

Promoting flexibility and efficiency, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents in early July, addressing oversight of next generation sequencing (NGS)-based tests and the databases that support clinical claims for these tests.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…