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  6. Increasing Choice and Competition through Innovation
  1. Focus Areas of Regulatory Science Report

Increasing Choice and Competition through Innovation

 

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Introduction

Scientific and technological innovation addressing public health needs are important drivers for FDA’s regulatory portfolio. To support the development of innovative products, FDA’s regulatory science research addresses knowledge gaps and improves the Agency’s familiarity with how new science and technology are applied to FDA-regulated products. FDA’s Emerging Sciences Working Group scans the horizon to identify new scientific trends that may affect products coming to FDA in the future. The identification of trends in this horizon-scanning may result in a new scientific working group, new employee recruitment, funding of intramural and extramural projects to address FDA’s needs, and new training programs or provision of other resources to FDA reviewers. FDA adapts and responds by actively promoting scientific and technological innovations, using innovative research tools to further advance development of innovative regulated products, and providing support and information about regulatory requirements to other innovators.

 

 

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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