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 In this section:

        Advancing Regulatory Science

Focus Areas of Regulatory Science Report

                        
                Opening Statement from the Commissioner
          Opening Statement from the Chief Scientist
          Focus Areas of Regulatory Science - Introduction
          Focus Areas of Regulatory Science - Approach
          Cross-cutting Topics: Minority Health and Health Equity Regulatory Science Research
          Cross-cutting Topics: Women’s Health Regulatory Science Research
          Cross-cutting Topics: Maternal Health Regulatory Science Research
          Cross-cutting Topics: Pediatric Health Regulatory Science Research
          Cross-cutting Topics: Oncology Regulatory Science Research
          Cross-cutting Topics: Rare Diseases Regulatory Science Research
          Cross-cutting Topics: One Health Initiative
          Lifecycle of FDA-Regulated Products
          Public Health Preparedness and Response
          Focus Area: Medical Countermeasures and Preparedness for Emerging Infectious Diseases
          Focus Area: Technologies to Reduce Pathogen Contamination
          Focus Area: Substance Use Disorders
          Focus Area: Antimicrobial Resistance​
          Focus Area: Food Safety
          Focus Area: Quality of Compounded Drugs
          Increasing Choice and Competition through Innovation
          Focus Area: Individualized Therapeutics and Precision Medicine
          Focus Area: Complex Innovative Trial Design
          Focus Area: Microbiome Research
          Focus Area: Novel Foods and Food Ingredients
          Focus Area: Regenerative Medicine
          Focus Area: Advanced Manufacturing
          Focus Area: Increasing Access to Complex Generic Drug Products
          Medical Product Development Tools
          Focus Area: Biomarkers
          Focus Area: Novel Technologies to Improve Predictivity of Non-clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing
          Focus Area: Model-Informed Product Development
          Unleashing the Power of Data
          Focus Area: Product Safety Surveillance
          Focus Area: Artificial Intelligence
          Focus Area: Digital Health Technologies
          Focus Area: Use of Real-World Evidence to Support Biologic, Device, and Drug Development and Regulatory Decision-Making
          Empowering Patients and Consumers
          Focus Area: Patient and Consumer Preferences and Perspectives
          Focus Area: Patient-Reported Outcomes and other Clinical Outcome Assessments
          Focus Area: Empowering Patients and Consumers to Make Better-Informed Decisions
          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
          Infrastructure: Facilities and Shared Resources
          Safety and Compliance Home
          Science & Research
          Science and Research Special Topics
          Advancing Regulatory Science
          Focus Areas of Regulatory Science ReportAdvancing 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.

New! 2022 Report: Printer-Friendly PDF [5.21MB] (September 2022)
	2021 Report: Printer-Friendly PDF [2.69MB]Resources For You

Advancing FDA’s Mission by Targeting Key Areas for Regulatory Science Investment and Innovation (FDA Voices, May 2021)
	FDA In Brief: FDA Publishes Report on Focus Areas of Regulatory Science (January 2021)
	Office of Regulatory Science and Innovation



**CROSS-CUTTING TOPICS**

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

**EXPLORE THE FOCUS AREAS OF REGULATORY SCIENCE**

Advanced Manufacturing
			Antimicrobial Resistance
			Artificial Intelligence
			BiomarkersComplex Innovative Trial Design
			Digital Health Technologies
			Empowering Patients and Consumers to Make Better-Informed Decisions
			Food SafetyIncreasing Access to Complex Generic Drug Products
			Individualized Therapeutics and Precision Medicine
			Medical Countermeasures and Preparedness for Emerging Infectious Diseases
			Microbiome ResearchModel-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 PerspectivesPatient-Reported Outcomes and other Clinical Outcome Assessments
			Product Safety Surveillance
			Quality of Compounded Drugs
			Regenerative MedicineSubstance 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 MechanismsScientific Education, Training, and Communication

Fellowship and Training Opportunities
			Professional Development and Continuing Education
			Communication and External MeetingsInfrastructure

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

                                                                                  Content current as of:
      09/06/2022Focus Areas of Regulatory Science Report                
                          

                        Opening Statement from the Commissioner
          Opening Statement from the Chief Scientist
          Introduction
          Approach
          Minority Health and Health Equity Regulatory Science Research
          Women’s Health Regulatory Science Research
          Maternal Health Regulatory Science Research
          Pediatric Health Regulatory Science Research
          Oncology Regulatory Science Research
          Rare Diseases Regulatory Science Research
          One Health Initiative
          Lifecycle of FDA-Regulated Products
          Public Health Preparedness and Response
          Medical Countermeasures & Preparedness - Emerging Infectious Diseases
          Technologies to Reduce Pathogen Contamination
          Substance Use Disorders
          Antimicrobial Resistance​
          Food Safety
          Quality of Compounded Drugs
          Increasing Choice and Competition through Innovation
          Individualized Therapeutics and Precision Medicine
          Complex Innovative Trial Design
          Microbiome Research
          Novel Foods and Food Ingredients
          Regenerative Medicine
          Advanced Manufacturing
          Increasing Access to Complex Generic Drug Products
          Medical Product Development Tools
          Biomarkers
          Novel Technologies to Improve Predictivity of Non-clinical Studies
          Model-Informed Product Development
          Unleashing the Power of Data
          Product Safety Surveillance
          Artificial Intelligence
          Digital Health Technologies
          Use of Real-World Evidence to Support Biologic, Device, & Drug Develop
          Empowering Patients and Consumers
          Patient and Consumer Preferences and Perspectives
          Patient-Reported Outcomes and other Clinical Outcome Assessments
          Empowering Patients and Consumers to Make Better-Informed Decisions
          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
          Infrastructure
          Safety and Compliance
 
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