FDA Unveils Streamlined Path for Authorizing Tumor-Profiling Tests Alongside Its Latest Product Action

April 20, 2018 – The U.S. Food and Drug Administration (FDA) recently finalized two guidances to drive the efficient development of next-generation sequencing, which scans a person’s DNA to diagnose genetic diseases, and guide medical treatments. The guidances provide recommendations for designing, developing, and validating tests that use the technology and will play an important role in the continued advancement of individualized, genetic-based medicine … (leggi tutto)