FDA has published a guidance for industry on an optional streamlined submission process for determining whether investigational in vitro diagnostic in clinical trials for an oncology therapeutic is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements.
While doing somewhat-routine reporting on this year’s Senate Appropriations Committee bills, Paul Goldberg, editor and publisher of The Cancer Letter, quickly realized that he was seeing a full bipartisan rejection of President Donald J. Trump’s plan to defund and therefore dismantle biomedical research in the United States.
