Below is a suggested template that submitters may modify to accommodate their submission data, as needed:
- 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
- Biomarker Qualification Overview
- Proposed context of use
- 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.
- Additional resources that support the context of use as well as data the submitter plans to obtain from ongoing or future studies.
- Indicate if there are plans to submit the biomarker for qualification by other international regulatory agencies
- Process-related questions for FDA
For downloadable version: