Tag Archives: Oncology

FDA Issues Guidance Regarding Obtaining Risk Determinations for Investigational IVDs in Oncology Trials

By Kurt R. Karst — On April 12, 2018, the three FDA Centers jointly issued the draft guidance, “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination” (draft available here). The draft guidance outlines a … Continue reading

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Ensuring Quality Cancer Care through the Oncology Workforce: Sustaining Care in the 21st Century. Wo

The American Society of Clinical Oncology (ASCO) predicts that by 2020, there will be an 81 percent increase in people living with or surviving cancer but only a 14 percent increase in the number of practicing oncologists. As a result, … Continue reading

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