Joint Fellowship Training Program
Program 3
Oncology Product Research/Review Fellows
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 division, these fellows will be matched to a pre-screened pool of principal investigators or to a branch chief for regulatory research and regulatory experience.
Fellows with a Ph.D. degree will be matched to a product division or pharmacology/toxicology branch in a clinical division. Fellows will have the option to perform translational research in the participating division or office. These fellows will undertake and participate in various training activities of the chosen division. The division director or their designee will oversee these activities. Fellows will spend approximately 40% of their time in training to become proficient in the process of product or pharmacology/toxicology 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 are expected to conduct research activities under the guidance of PIs in ongoing projects in the lab. These fellows will have option to choose their PI at the beginning of program.
During the training program, fellows will be expected to attend and take and pass required tests in reviewer training and various courses offered by participating FDA Centers.
Second Year Curricula and Responsibilities
The first-year curricula and activities may be continued in the second year of the program based on the fellow's performance evaluated by PI, branch chief, division director and associate directors of research at both institutions.
