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  1. Focus Areas of Regulatory Science Report

Focus Areas of Regulatory Science - Approach

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

In 2020, FDA formed an Agency-wide committee of scientific leaders to develop an efficient way to communicate to its stakeholders its regulatory science needs and activities. The committee surveyed the Agency’s working groups, councils, and research teams, and developed the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS). The intention of the report was to communicate areas FDA identified as needing continued targeted investment to fulfill FDA’s regulatory and public health mission. The format is designed to easily accommodate frequent updates and revisions to align with the rapid pace of scientific advancement as well as evolving priorities and research activities. Each focus area section follows the same format: a description of why the focus area is important to FDA and examples of recent and ongoing research. In 2021, the main updates were to the examples, although minor updates were also made to the importance statements of some of the focus areas.

We continue to emphasize that the FARS are not intended to be a comprehensive list of all FDA areas of regulatory science and recognize there are many efforts and initiatives on-going at the Agency that are not included here. Center- and office-specific research outside of the current FARS are no less important than the identified FARS. Additionally, some of the research FDA conducts is preliminary in nature, and inclusion in FARS does not necessarily imply any determination about use for or role in regulatory decision-making.

The FARS are organized across four initiatives established in 2020:

FARS-related research is conducted through a variety of mechanisms and collaborations, such as intramural and extramural regulatory science programs identified by FDA centers and offices. This report also highlights the Research Capabilities, Tools, and Resources available that centers and offices utilize when performing any regulatory science research. That section includes descriptions of:

Cross-cutting Topics

In developing the FARS, FDA determined that certain topics encompass multiple focus areas because of broad application. As such, FDA identified the following cross-cutting topics underlying much of FDA’s regulatory science research: Minority Health and Health Equity, Women’s Health, Pediatric Health, Oncology, Rare Diseases and the One Health Initiative. Moreover, additional consideration was given to describing the lifecycle of FDA-regulated products; the committee included details for how FARS can influence different aspects of that lifecycle.

The Coronavirus Disease 2019 (COVID-19) pandemic is central to many of the research examples listed in the FARS. COVID-19 is a contagious respiratory disease caused by infection with a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In 2020, FDA initiated an ongoing rapid response to the pandemic including conducting regulatory evaluations of medical products used to diagnose, treat, or prevent COVID-19, and developed new research programs to facilitate development and regulatory evaluation of these critical medical countermeasures.

 

 

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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