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  1. Biomarker Qualification Program

Resources for Biomarker Requestors

How to engage with the Biomarker Qualification Program (BQP)

If you have pre-submission or general inquiry questions or you want to make a meeting request, please contact BQP at: CDER-BiomarkerQualificationProgram@fda.hhs.gov

Qualification Process

Biomarker qualification is a process involving three stages that provide increasing levels of detail for the development of a biomarker for its proposed context of use (COU). Here we provide resources to assist requestors in making complete submissions to the CDER Biomarker Qualification Program.

See 21st Century Cures Act: Qualification of DDT for a description of how the process for qualification of drug development tools is changing under new FD&C Act Section 507. For guidance on the Drug Development Tool Qualification Process, click HERE or for additional information to aid in completion of a submission, please see links under the heading Important Information for Requestors below.

Qualification Stages & Submissions

Stage Content Element Outlines
1 Letter of Intent (LOI) (PDF)
2 Qualification Plan (QP) (PDF)
3 Full Qualification Package (FQP) 
FQP Flyer (PDF)
4 BQP Cover Letter (PDF)

Biomarker Qualification Submission Procedures

As part of an ongoing effort to modernize FDA interactions with requestors, we are pleased to announce the launch of the NextGen Collaboration Portal.

NextGen Portal is intended to provide requestors with an easier and more efficient way to make submissions, receive submission related communications, track and manage BQP projects. The Portal is used for requestor submission of LOI, QP and FQP. Currently the Portal is not used for meeting related correspondence. Meeting requests and other general enquiries are made via email using the CDER-BiomarkerQualificationProgram@fda.hhs.gov address.

Once on the CDER’s NextGen Collaboration Portal website, follow the step-by-step guide to create and activate an account using Portal's secure multi-factor authentication process.

For detailed instructions and video guidance on how to transmit a submission through NextGen Collaboration Portal to the Biomarker Qualification Program, please select the “Get Started with your Submission (FAQs)” button below:

Get Started With Your DDT Submission (FAQs)

Request a Pre-LOI Meeting with the Biomarker Qualification Program (BQP):

A Pre-LOI meeting serves as an opportunity for Requestors to receive guidance from FDA regarding their biomarker programs. This is a 30-45-minute teleconference intended to provide non-binding advice to requestors who plan to submit a LOI submission to the Biomarker Qualification Program (BQP). Topics may include discussions about the requirements for the CDER biomarker qualification program, intended use of the biomarker and various pathways to engage with FDA. To request a Pre-LOI meeting, please email us at CDER-BiomarkerQualificationProgram@fda.hhs.gov. Your written request should include:

  • Cover Letter to BQP Program which includes three proposed dates (within 60 days of your request) and proposed agenda for a 30-45 minute meeting
  • Specific questions to the Biomarker Qualification Program (BQP) in PowerPoint format. Please provide a 10-15-minute background slide presentation containing biomarker name, Context of Use (COU) and Drug Development Need and any relevant information
  • Draft Letter of Intent (LOI) (Refer to Qualification Stages & Submissions section)

Important Information for Requestors

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