Focus Areas of Regulatory Science Report
2022 Update to the Focus Areas of Regulatory Science (FARS) Report
The FDA conducts research that advances regulatory science, the science of developing tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Regulatory science facilitates evaluation or development of FDA-regulated products, and supports regulatory decision-making and policy development. It also enables the FDA to understand and assess risk, prepare for and respond to public health emergencies, and help ensure the safety or reduce the harm of products used or consumed by patients and consumers.
The 2022 update to the Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted investment. This new web layout enables stakeholders to more easily access and search content related to each individual focus area, using the navigational links on this page, including quick links to cross-cutting topics below. Additionally, we have published the update in a new report accessible in PDF format.
A key purpose of the FARS report is to communicate the importance and impact of FDA’s cross-cutting ongoing regulatory science research activities on a regular basis. Because the FDA aims to stay ahead of evolving regulatory needs, we have reviewed each of the focus areas from the 2021 report and provided important updates to the examples highlighted in the report. 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.
- New! 2022 Report: Printer-Friendly PDF [5.21MB] (September 2022)
- 2021 Report: Printer-Friendly PDF [2.69MB]
Resources For You
- Advancing FDA’s Mission by Targeting Key Areas for Regulatory Science Investment and Innovation (FDA Voices, May 2021)
- FDA In Brief: FDA Publishes Report on Focus Areas of Regulatory Science (January 2021)
- Office of Regulatory Science and Innovation
|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||Contact Us: FARS@fda.hhs.gov|