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  5. Focus Areas of Regulatory Science Report
  6. Physical Standards and Reference Materials
  1. Focus Areas of Regulatory Science Report

Physical Standards and Reference Materials

Medical science professionals working in a laboratory.

Physical standards and reference materials are substances or materials produced in a controlled environment that are used as a “calibrator” to produce additional substances or materials (e.g., materials of documented purity certified by an analytical laboratory or other noncommercial establishment). FDA scientists may develop standards and reference materials and may depend on internal or external lab consortia for validation and distribution. In addition, external parties (e.g., U.S. National Institute of Standards and Technology and National Institute of Biological Standards and Control in the United Kingdom) develop standards and reference materials and depend on FDA laboratories to participate in validation studies. For example, annually, FDA develops, validates, and distributes the strain-matched standard of the seasonal and pandemic strains of the influenza vaccine for potency (effectiveness) testing. The Agency also participates in developing standards for a variety of regulated products that are often later adopted as international standards by the World Health Organization (WHO). Currently, FDA laboratories are involved in an international multi-laboratory study endorsed by WHO to validate reference materials for SARS-CoV-2 ribonucleic acid (RNA) and antibody detection assays. Some of FDA’s laboratories also function as a WHO Collaborating Center.

Another example where FDA facilitates product development through references is the FDA-ARGOS database which provides reference-grade microbial sequences to enable sequence-based diagnostic assays.

 

 

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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