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  1. Advancing Regulatory Science

Focus Areas of Regulatory Science Report

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Graphic showing the front cover of the “Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS)” 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.

Resources For You

 

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 and Emerging Science

 Contact Us: FARS@fda.hhs.gov


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