Joint Fellowship Training Program
Program 3
Oncology Product Research/Review Fellows:
This fellowship will train individuals in the aspects of research and review of medical product development process to facilitate the movement of drugs, biologics, and devices from the bench to the bedside. Graduates of this program will develop skills of value to academia, the pharmaceutical industry, and government agencies. Those eligible to participate will possess a Ph.D., M.D., or M.D./Ph.D. degree and a minimum of three years of postdoctoral training in a cancer-related topic and hold US citizenship or US permanent residency. Participants will spend up to two years at FDA. While at FDA, fellows will receive formal training and mentoring in the relevant federal statutes, regulations, principles, and practices of FDA medical product review, including issues related to product development, e.g., manufacturing processes, production, purification, characterization, testing, quality control, and quality assurance, understanding the biology, chemistry, pharmacoepidemiology, manufacturing, postmarketing surveillance, and mechanism of action/pathogenesis of disease. Fellows will also participate in medical product development research projects. Fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff. The program time frame will be for up to two years and include up to six fellows per year.
