U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Development Tool (DDT) Qualification Programs
  5. Biomarker Cover Letter Template
  1. Drug Development Tool (DDT) Qualification Programs

Biomarker Cover Letter Template

  • Date:
  • Subject: (in bold print) DDT QUALIFICATION SUBMISSION
  • DDT Type: (in bold print), BIOMARKER
  • DDT Tracking Record Number (if previously assigned): (in bold print) DDT BIOMARKER XXXXXX
  • Submission Type: (in bold print)
        • PRE-SUBMISSION REQUEST   or
        • LETTER OF INTENT    or
        • INITIAL BRIEFING PACKAGE SUBMISSION   or 
        • SUPPORTING DOCUMENT FOR CONSULTATION AND ADVICE STAGE    or  
        • QUALIFICATION PACKAGE
  • DDT Name(s): (in bold print): Identify the specific DDT (by name) that is being submitted
  • Context of Use: Describe the intended use of the DDT (1 to 2 sentences)
  • Complete submitter contact information including name(s), affiliation, mailing address, email address, phone and fax numbers

ResourcesForYou

Back to Top