Centers and offices manage regulatory science research by evaluating it both prospectively and retrospectively, using internal and/or external scientific review. Many centers and offices also have research governance bodies to engage leadership in discussions of policies and decisions around research goals, priorities, and processes. Outcomes of such reviews are incorporated into decision-making, which informs resource allocation, such as funding, staffing, equipment, and laboratory space.
To identify best practices across the agency and better understanding of approaches used to evaluate the impact of research that is conducted or funded by FDA, the SSC-chartered the Research Impact Work Group.
FDA uses the FDA Science Board to perform periodic external reviews of the research programs conducted in centers and offices. These reviews are high-level and often focused on evaluation of the current portfolio, assessment of future trends, and needs for new research endeavors as well as providing input into the processes used to manage the research resources.
Researchers throughout the Agency comply with the requirement to increase access to federally funded scientific research by using data management plans to prospectively identify how and what types of research data underlying research published in peer-reviewed scientific journals may be shared, as appropriate. In addition, FDA’s researchers are encouraged to publish their scientific findings in peer-reviewed scientific journals. In some rare cases (such as investigations of regulated products), the findings may not be published publicly, but the results are internally catalogued. All external research publications are collected in the publicly accessible FDA-wide research publication database.
Since FDA is a regulatory agency, the impact of its regulatory science research goes beyond just what FDA publishes in scientific journals. Often the expertise and results from our research directly informs development of regulatory policies, guidance documents, the FDA Foods Program Compendium of Analytical Methods, and review of regulatory submissions through guidance and regulatory decision-making on a daily basis.
FDA often partners with standard development organizations to identify and develop community consensus standards. The use of voluntary consensus standards can facilitate product development and reduce the amount of documentation needed in a regulatory submission, thus contributing to a more efficient submission evaluation and, ultimately, improving time to market. Yearly, FDA participates in the development of The National Technology Transfer and Advancement Act (NTTAA) report. The Act mandates that all federal agencies use technical standards developed and adopted by voluntary consensus standards bodies, as opposed to using government-unique standards.
|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|