Investigational in Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination

April 17, 2018 – On April 16, 2018, the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Investigational in Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination,” to describe for sponsors of certain oncology trials an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic (IVD) in a trial of investigational cancer drug or biologic products is … (leggi tutto)