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FDA In Brief: FDA Publishes Report on Focus Areas of Regulatory Science

January 11, 2021

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The following quote is attributed to RADM Denise Hinton, FDA Chief Scientist:

“The FDA conducts regulatory science research, which is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of certain FDA-regulated products. It also enables the FDA to understand and assess risk, prepare for and respond to public health emergencies and help ensure the safety of products used by patients.   

“Today, we released the Focus Areas of Regulatory Science (FARS) report, which outlines topics that the FDA has identified as needing continued targeted investment in regulatory science research to facilitate the development of innovative products, provide data and methodology to inform regulatory decision-making and improve guidance to sponsors. Each FARS aligns with one of four strategic initiatives.

“The focus areas are not intended to be a comprehensive list of all the FDA’s research needs, but generally encompasses research affecting more than one center or office. The areas identified have been designed to be flexible so they can be updated as needed to address evolving regulatory needs.”

Additional Information:

  • The U.S. Food and Drug Administration is publishing the report, 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS), to communicate the importance and impact of the FDA’s scientific research and activities. 
  • The FARS are organized across three strategic initiatives identified by FDA Commissioner Stephen M. Hahn, M.D. in 2020: Increasing Choice and Competition through Innovation; Unleashing the Power of Data; and Empowering Patients and Consumers. The agency-wide committee tasked with developing the FARS added a fourth initiative, Public Health Emergency Preparedness and Response, due to the critical role of research dedicated to this need.  
  • Data arising from regulatory science research are typically made publicly available through peer-reviewed scientific publication, and supports education and best practices, sharing with industry, regulatory decision-making, development of agency guidance documents, review and approval decisions, regulations, consumer advisories, labeling, industry warnings and recalls.

Additional Resources:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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