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  6. Medical Product Development Tools
  1. Focus Areas of Regulatory Science Report

Medical Product Development Tools

 

A collage of photos showing a teenage girl entering an MRI machine, a gloved hand inserting a syringe into a vaccine vial, and a pile of prescription pill bottles.

Publicly available, FDA-qualified, medical product development tools facilitate industry’s ability to harness innovative science and technology. These tools, methods, and models are used to reduce the time, complexity, or cost of developing FDA-regulated products, while increasing the reliability and robustness of the results used to support product development.

 

 

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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