Director: Richard Pazdur, M.D.
Team Leader, Project Management Officer: Dianne Spillman
The Oncology Program works with Centers within FDA and with external stakeholders to initiate, develop, co-ordinate, and communicate cross-cutting FDA initiatives in oncology. The Program's strategic goals are to identify emerging technologies that may speed the development of new therapies for cancer; examine the regulatory implications of such breakthroughs; and devise strategies for consistent, rational alignment of regulatory policy with scientific advances.
Major areas of focus in the program include:
- FDA's Critical Path Initiative
- Clinical Data Interchange Standards Consortium (CDISC)
- Conducting Clinical Trials