FDA Watch: Agency Issues New Guidance to Ease Approval of NGS Tests & IVD Devices

摘要

April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing (NGS) tests, as well as a draft guidance outlining a proposed new voluntary, streamlined submission process for evaluating the risks of investigational in vitro diagnostics (IVDs) being codeveloped alongside a trial cancer drug.