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  1. Focus Areas of Regulatory Science Report

Empowering Patients and Consumers

 

A collage of photos showing an African-American woman grocery shopping with her toddler daughter, an elderly man looking at a prescription pill bottle, a mixed-race couple speaking to a female doctor, and a veterinarian holding a small puppy.

Introduction

FDA is developing new ways to engage patients and consumers to better understand the American patients’ and the public’s perspectives and preferences including related to outcomes. The scope of products regulated by FDA affects consumers and patients, including the veterinary client-patient relationship (VCPR). Understanding patient, consumer, and VCPR perspectives and preferences including related to outcomes enables FDA to understand what matters most in new treatments and develop targeted and easy-to-understand communications and resources to empower the diverse American public to make better informed decisions. If consumers, patients, caregivers, and healthcare professionals become more informed about the products FDA regulates, they can live healthier and more productive lives.

 

 

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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