Resources for Biomarker Requestors
How to engage with the Biomarker Qualification Program (BQP)
If you have a preliminary submission, 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 requesters in making complete submissions to FDA’s 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 the 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/drugs/biomarker-qualification-program/resources-biomarker-requestors#important
| Stage | Content Element Outlines |
|---|---|
| 1 | Letter of Intent (LOI) (PDF) |
| 2 | Qualification Plan (QP) (PDF) |
| 3 | Full Qualification Package (FQP) FQP Flyer (PDF) |
| All Stages | 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.
The NextGen Collaboration Portal is intended to provide requesters with an easier and more efficient way to make submissions, receive submission-related communications, track and manage BQP projects, and request meetings. The Portal is used for requester submission of LOI, QP, and FQP. Currently the Portal is not used for Pre-LOI meeting related correspondence. Pre-LOI meeting requests and other general inquiries 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 the Portal's secure multi-factor authentication process.
For detailed instructions and video guidance on how to transmit a submission through the NextGen Collaboration Portal to the Biomarker Qualification Program, please select the “Get Started with your DDT Submission (FAQs)” button below:
Get Started With Your DDT Submission (FAQs)
Request a Meeting with the Biomarker Qualification Program:
The Biomarker Qualification Program (BQP) offers two types of meetings: pre-submission meetings and debrief meetings.
Preliminary Qualification Meetings
A pre-submission meeting serves as an opportunity for requesters who plan to submit an LOI, QP, or FQP submission to the BQP, to receive non-binding advice from the FDA. A pre-submission meeting is a 30-45 minute video/teleconference to discuss topics such as requirements for the Biomarker Qualification Program, intended use of the biomarker, and other topics related to the biomarker’s potential qualification.
Requesting a Pre-LOI Meeting
To request a preliminary meeting, please email us at CDER BiomarkerQualificationProgram@fda.hhs.gov. Your written request should include:
- Cover Letter to the BQP which includes three proposed dates (within 60 days of your request) and proposed agenda for a 30-45 minute meeting.
- Specific questions to the BQP in PowerPoint format. Please provide a 10-15 minute background slide presentation containing biomarker name, proposed Context of Use (COU), and Drug Development Need and any relevant information.
- Draft Letter of Intent. Note, to assist you in preparing this draft, refer to the Qualification Stages & Submissions section, where you can find the LOI content element outline. Although detailed information is not required at this stage, organizing your draft according to the outline will help you formulate any questions you may have for staff and better prepare for the upcoming meeting. Using this structure ensures a more efficient and productive review process.
In cases where it is not feasible to grant a meeting, we may provide you with written responses to your specific questions.
Requesting a Pre-QP or Pre-FQP Meeting
To request a pre-submission meeting, submit a meeting request through the NextGen Collaboration Portal by selecting your DDT Number from the landing page, clicking the Actions dropdown and then selecting Meeting Request. Please refer to the step-by-step instructions for submitting a meeting request and presentation materials to the Biomarker Qualification Program.
Your meeting request should include:
- Cover Letter to the BQP which includes three proposed dates (within 60 days of your request) and proposed agenda for a 30-45 minute meeting.
- Specific questions to the BQP in PowerPoint format. Please provide a 10-15 minute background slide presentation containing biomarker name, proposed Context of Use (COU), and Drug Development Need and any relevant information.
- Draft QP or FQP. Note, to assist you in preparing this draft, refer to the Qualification Stages & Submissions section, where you can find the content element outline for each document type. Although detailed information is not required at this stage, organizing your draft according to the outline will help you formulate any questions you may have for staff and better prepare for the upcoming meeting. Using this structure ensures a more efficient and productive review process.
Debrief Meetings
We also offer requestors the opportunity to request a debrief meeting following a decision letter issuance to clarify questions regarding the decision letter. The meeting is not an opportunity for the requester to bring up new topics unrelated to the response letter. A debrief meeting is a 30-45 minute teleconference intended to provide non-binding advice to requestors.
Requesting a Debrief Meeting
To request a debrief meeting, submit a meeting request through the NextGen Collaboration Portal by selecting your DDT Number from the landing page, clicking the Actions dropdown and then selecting Meeting Request. Please refer to the step-by-step instructions for submitting a meeting request and presentation materials to the Biomarker Qualification Program.
Your meeting request should include:
- Cover Letter to the BQP which includes three proposed dates (within 60 days of your request) and proposed agenda for a 30-45 minute meeting.
- Specific questions to the BQP in PowerPoint format and a 10-15 minute slide presentation with relevant information.
In cases where it is not feasible to grant a meeting, we may provide you with written responses to your specific questions.