Joint Fellowship Training Program
Program 2
Clinical Oncology Product Research/Review for Board Certified (BC) Oncologists
First Year Curricula and Responsibilities
Fellows will choose one of the product or clinical divisions in FDA Centers for supplemental training. In a particular product or clinical division, these fellows will be matched to a pre-screened pool of principal investigators for regulatory research and review or to a branch chief for regulatory review and policies. These fellows will have the option to participate in translational research in the participating division.
Fellows will undertake and participate in various regulatory activities of the chosen division. The division director or their designee will oversee these activities. Regulatory activities include but are not limited to training courses and reviews of files to become proficient in the process of product, pharmacology/toxicology or clinical reviews; and policy and guidance document development. Fellows will also participate in branch, lab, division, and office meetings; grand rounds; and regulatory presentations offered at the participating Center. They will also participate in regulatory meetings with investigators and sponsors.
Fellows have the option to participate in translational research activities under the guidance of PIs in ongoing projects in the lab. These fellows will have the option to choose their PI at the beginning of the program.
During the training program, these fellows will be expected to attend and take and pass required tests in reviewer training and various courses offered by participating FDA Centers.
