Joint Fellowship Training Program
Program 2
Clinical Oncology Product Research/Review for Board Certified (BC) Oncologists
This fellowship will train physicians who have already completed their oncology clinical fellowship and hold US citizenship or US permanent residency. As part of this program, participants will be trained in aspects of the drug, biologic, or device development and related issues and standards for assessing medical product safety and efficacy, to facilitate the movement of drugs, biologics, and devices from basic bench science to commercialization. While at FDA, fellows will receive formal training and mentoring in the relevant federal statutes, regulations, principles and practices of FDA medical review, including issues related to the assessment of safety and efficacy, for limited human exposure in clinical trials, and later potential exposure to the broader patient population postmarketing approval. While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff. This is a one-year program for up to three fellows per year.