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  1. CDER Biomarker Qualification Program

Biomarker Full Qualification Package

Full Qualification Package (PDF - 162KB)

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Below is a suggested template that requestors may modify to accommodate their submission data, as needed:

  1. Executive Summary
  2. Background
  3. Proposed Context of Use (COU)
  4. Summary of Supporting Data
  5. Methodologies
  6. Results
  7. Appendices
  1. Executive Summary

  2. Background

    • Importance of the specified biomarker as a drug development tool
    • The background for the disease and/or organ toxicity
  3. Proposed Context of Use (COU)

    • Proposed COU (Use Statement and Conditions for Qualified Use) to include:
      • Disease area/organ toxicity
      • Targeted population
  4. Summary of Supporting Data

    • Supportive nonclinical and clinical studies
    • Additional evidence from published literature
  5. Methodologies

    • Performance characteristics and methodologies of the analytically validated biomarker assays used
    • Imaging modalities, as applicable
    • Chart, graphs, plots, flowcharts etc., as applicable
    • Data collection and analysis methodologies such as analysis endpoint/s, baseline data, missing data, sensitivity analysis etc.
    • Statistical Analysis Plan
    • Codes such as SAS codes used in data analyses, as applicable
  6. Results

    • Raw data from clinical/nonclinical studies, protocols, testing conditions, populations tested, and the outcome of the performed study
    • All data sources, datasets (exploratory, confirmatory etc.), Registry and database(s)
    • A report that combines results from all studies, analyses (statistical and modeling) and conclusions
    • A conclusion summary that describes key findings from all the studies conducted and discusses how the key findings support the use of the proposed biomarker as a drug development tool.
  7. Appendices

    • Any supporting material such as references, peer-reviewed literature, summaries or statements from other regulatory agencies, academia, consortia, medical boards that may highlight the use of biomarkers
    • Upon qualification, reviews of the submitted qualification package and the qualification recommendation will be available on the Biomarker Qualification Program website. Please include a statement acknowledging that you are aware of this plan and do not object to written summary reviews being made publicly available.


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