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  1. Focus Areas of Regulatory Science Report

Opening Statement from the Chief Scientist

Namandjé N. Bumpus  and Jacqueline A. O’Shaughnessy
                    Namandjé N. Bumpus                                                              Jacqueline A. O’Shaughnessy

Chief Scientist Dr. Namandjé N. Bumpus and
Deputy Chief Scientist Dr. Jacqueline A. O’Shaughnessy

Every day, FDA research scientists address regulatory challenges to provide scientific and objective data, tools, and expertise to support evaluation of FDA-regulated products. As an agency, we are committed to making important regulatory decisions that use sound science and data. We do this by performing intramural research and scientific activities, collaborating with stakeholders in the scientific community, and harnessing the best science to ensure that we have the expertise and resources to improve processes, inform decision-making, and enable innovation in support of FDA’s mission.

A key purpose of the Focus Areas of Regulatory Science (FARS) is to communicate the importance and impact of FDA’s cross-cutting on-going regulatory science research activities on a regulator basis. Because we aim to stay ahead of evolving regulatory needs, we have reviewed each of the FARS from the 2021 report and provided important updates to the examples highlighted in the FARS. The ability to stay agile with regular updating ensures that the FARS include the most current topics and examples of FDA’s regulatory science to fulfill our regulatory responsibilities.

Additionally, we aim to advance regulatory science in several cross-cutting areas. In the 2021 report, we identified priorities in women’s health, minority health, health equity across diverse groups, and the One Health initiative. In 2022, we bolstered our cross-cutting topics to include pediatric health, rare diseases, and oncology. Lastly, we continue to emphasize that the FARS are not intended to be a comprehensive list of all FDA areas of regulatory science and recognize there are many on-going efforts and initiatives at the Agency that are not included in this report. Center- and office-specific research outside of the current FARS are no less important than the identified FARS.

We are proud to highlight these achievements of our scientists, supporting our mission to protect and advance public health by helping to speed innovations in regulatory science. And the Office of the Chief Scientist will continue to support FDA’s centers and offices as we partner with the broader scientific community to advance regulatory science, research, and innovation as we aim to harness the vast potential of rapidly evolving technologies in support of FDA’s mission.




Minority Health and Health Equity Women’s Health Maternal Health Pediatric Health
Oncology Rare Diseases One Health Initiative  



Research Capabilities, Tools, and Resources

Research Management and Collaborations Technology Transfer and Public-Private Partnerships Physical Standards and Reference Materials Intramural Grant Programs Extramural Funding Mechanisms

Scientific Education, Training, and Communication

Fellowship and Training Opportunities Professional Development and Continuing Education Communication and External Meetings


Facilities and Shared Resources Safety and Compliance



Office of the Chief Scientist

Office of Regulatory Science and Innovation

Contact Us: FARS@fda.hhs.gov


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