Overview

The United States (U.S.) Department of Health and Human Services (HHS), Food and Drug Administration (FDA) regulates and oversees a broad range of products used by the American public every day, from human and animal food, cosmetics, and tobacco, to medical products, such as drugs, biologics, and medical devices. Together, FDA’s multi-disciplinary workforce of approximately 18,000 employees supports the oversight of FDA-regulated products. FDA is responsible for oversight of more than $2.8 trillion of food, medical products, cosmetics, and tobacco, accounting for roughly 20 cents of every dollar spent by U.S. consumers.

The health and well-being of the American public depend on FDA’s science-based regulatory decisions. Under the authority of Congress, FDA creates rules and regulations based on the laws set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act, Public Law 97-414), and other laws, to fulfill its public health mission. FDA scientists conduct regulatory science to create data, tools, models, and methods to facilitate evaluation or development of FDA-regulated products as well as to support regulatory decision-making and policy development. While industry mainly focuses on product development and academia focuses on the scientific underpinnings, FDA, in addition to its other activities, conducts or supports regulatory science research that concentrates on developing test methods, models and knowledge of the science needed to support regulatory evaluation.

Regulatory science is essential because it enables FDA to understand and assess risks, prepare for public health emergencies, and ultimately help ensure the safety or reduce the harm of products used or consumed by the public. FDA does this by providing scientific, non-biased, and objective expertise for the products under FDA’s jurisdiction. Our use of regulatory science supports FDA’s mission in a variety of ways, like developing assays, animal models, data analysis tools, scientifically sound guidance, and reference materials or standards used by FDA in the regulatory process and sponsors developing FDA-regulated products. Moreover, output from regulatory science supports education by sharing best practices through guidance with national and international stakeholders; supports regulatory decision-making through marketing authorization decisions, regulations, consumer advisories, labeling, industry warnings, and recalls.