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  6. Focus Areas of Regulatory Science - Introduction
  1. Focus Areas of Regulatory Science Report

Focus Areas of Regulatory Science - Introduction

 

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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 the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of some FDA-regulated products.

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.

 

 

 

CROSS-CUTTING TOPICS

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

 

EXPLORE THE FOCUS AREAS OF REGULATORY SCIENCE

Advanced Manufacturing Antimicrobial Resistance Artificial Intelligence Biomarkers
Complex Innovative Trial Design Digital Health Technologies Empowering Patients and Consumers to Make Better-Informed Decisions Food Safety
Increasing Access to Complex Generic Drug Products Individualized Therapeutics and Precision Medicine Medical Countermeasures and Preparedness for Emerging Infectious Diseases Microbiome Research
Model-Informed Product Development Novel Foods and Food Ingredients Novel Technologies to Improve Predictivity of Non-clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing Patient and Consumer Preferences and Perspectives
Patient-Reported Outcomes and other Clinical Outcome Assessments Product Safety Surveillance Quality of Compounded Drugs Regenerative Medicine
  Substance Use Disorders Technologies to Reduce Pathogen Contamination Use of Real-World Evidence to Support Biologic, Device, and Drug Development and Regulatory Decision-Making

 

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

Infrastructure

Facilities and Shared Resources Safety and Compliance

 

ADDITIONAL ORGANIZATIONAL INFORMATION

Office of the Chief Scientist

Office of Regulatory Science and Innovation

 Contact Us: FARS@fda.hhs.gov

 

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