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.
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