On Feb. 16, 2005, in preparation for the new generation of molecular-based oncology medical products, the National Cancer Institute and FDA established an NCI-FDA Research and Regulatory Review Fellowship program. The program is designed to train a cadre of researchers to bridge the processes from scientific discovery through clinical development and regulatory review of new oncology products. The new generation of targeted therapies and diagnostic products will demand new skills and processes that must be incorporated into the current research and regulatory system. The NCI-FDA fellowship program represents an innovative and collaborative approach to that objective. The NCI-FDA Research and Regulatory Fellowship program is an initiative of NCI’s and FDA’s Interagency Oncology Task Force (IOTF), a major collaboration between the 2 agencies. The IOTF was established in recognition of the fact that cross-fertilization between the NCI and FDA is critical for developing the knowledge base necessary to bring new, molecular-based therapies and diagnostics into the clinical practice of oncology.