On 12 April 2018, the Food and Drug Administration (FDA) finalized a guidance document, Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases, in efforts to accelerate the establishment of a regulatory approach for next generation sequencing (NGS) testing
Learn more at: By Frank Luh & Yun Yen