Pursuant to the 21st Century Cures Act, FDA established the Oncology Center of Excellence (OCE). It leverages the combined skills of regulatory scientists and reviewers with expertise in the development of drugs, biological products, devices, and diagnostics to support an integrated approach to the clinical evaluation of medical products addressing cancer. For medical oncology products, OCE forms an interdisciplinary medical oncology review and evaluation team with representatives from the appropriate centers.

OCE oversees a robust regulatory science effort focusing on scientific research questions that arise during regulatory review of oncology products. In general, OCE emphasizes applied research that focuses on solving a specific practical problem rather than expanding general knowledge. Based on an analysis of scientific outreach activities, internal presentations, publications and technology transfer agreements, OCE identified nine scientific priority areas and one cross-cutting area of high interest for research. These are not the only areas of interest to OCE but represent topics with substantial existing activity.

OCE supports several intramural research projects, with a strong focus on conducting pooled analyses of clinical trial data. OCE supports extramural research projects through the BAA and CERSI programs and collaborates with some external partners using technology transfer agreements.