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  1. Focus Areas of Regulatory Science Report

Research Capabilities, Tools, and Resources

 

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Introduction

Research addressing each of the FARS is funded through a combination of intramural and extramural grants and contracts managed by centers and Agency-wide offices. Agency resources are critical to fully support intramural and extramural research addressing the FARS. The Office of the Chief Scientist (OCS) facilitates coordination and administration of some of the shared resources in collaboration with centers and offices. OCS also oversees the Agency-wide Senior Science Council (SSC), comprising scientific leadership from each of the centers, the Office of Regulatory Affairs (ORA), and the Office of the Commissioner’s component offices, as relevant. OCS provides advice and guidance to the Agency and center leadership on cross-cutting regulatory science issues, including on planning, reporting, programs, policies, and communication. FDA centers and offices have primary authority over their own research resources in terms of setting strategic priorities, allocating research resources to high-quality, mission-relevant scientific projects, and having in place systems for periodic and systematic evaluation of the research productivity, outcomes, and impacts.

 

 

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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