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.
In his new book, “No More Tears: The Dark Secrets of Johnson & Johnson,” Gardiner Harris, who was previously the public health and pharmaceutical business reporter for The New York Times, talks about the history of the overuse of red blood cell growth factors in oncology.
