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U.S. Department of Health and Human Services

Drugs

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Letter of Intent to Propose Biomarker Qualification

  1. Administrative structure

Description of the Submitter including, but not limited to Principal Investigator(s), Working Group Member(s), institutions, and contact information not contained within the cover letter

  1. Biomarker Qualification Overview
    1. Introduction
    2. Proposed context of use
    3. High-level data description (1 to 2 pages in length). This description should provide a data overview that not only supports the use of the biomarker for the proposed context of use, but also encourages FDA engagement because of drug development applicability.
    4. Additional resources that support the context of use as well as data the submitter plans to obtain from ongoing or future studies.
    5. Indicate if there are plans to submit the biomarker for qualification by other international regulatory agencies
  2. Process-related questions for FDA