Drugs
Biomarker Qualification Process
Presubmission Submitter forwards email with Biomarker cover letter as attachment to CDER Biomarker Qualification Program (BQP) contact
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Presubmission administrative and scientific readiness assessed by CDER
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CDER BQP contact advises Submitter of next steps and when to proceed with a Letter of Intent
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Consultation and Submitter forwards paper DDT cover letter and electronic media
Advice containing Letter of Intent (LOI) to CDER Central Document
(Stage 1) Room address
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Upon receipt, LOI is assessed by CDER and a determination is made about whether or not to formally accept this submission into the CDER BQP
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After acceptance of LOI into CDER BQP, a Qualification Review Team (QRT) is formed
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QRT identifies topics that should be addressed in the Initial Briefing Package
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CDER BQP contact forwards QRT-identified topics and invites Submitter to send Initial Briefing Package
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Submitter provides CDER BQP contact with expected submission date for Initial Briefing Package at least one month in advance in order to facilitate meeting scheduling
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Submitter forwards paper DDT cover letter and electronic media containing Initial Briefing Package to CDER Central Document Room address
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Upon receipt of Initial Briefing Package, if not done in advance of Briefing Package receipt, a meeting is scheduled between Submitter and QRT
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QRT formulates preliminary advice and provides this information to the Submitter in advance of the meeting
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Based on advice, Submitter determines topics/responses for discussion at meeting and forwards presentation materials to CDER BQP contact in advance of meeting
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Following the meeting, the Submitter considers advice given (meeting minutes will be sent to submitter) and obtains additional evidence as needed to address important knowledge gaps
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As new information is obtained by Submitter, cycles of submitting new Briefing Documents, meetings, and addressing important knowledge gaps will continue until Submitter believes all needed information has been obtained
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Submitter requests meeting through CDER BQP contact, and provides Briefing Document, to assess completion of data collection and to determine if consensus can be reached between Submitter and QRT about proceeding to submission of Qualification package
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If no obvious knowledge gaps exist and all issues appear to be addressed, CDER BQP contact invites Submitter to forward single, unified, Qualification package. (CDER BQP contacts advise Submitter on format and needed content for submission)
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Submitter prepares Qualification Package, and provides CDER BQP contact with advance notice of expected submission date for Qualification Package as feasible
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Submitter forwards paper DDT cover letter and electronic media containing Qualification Package to CDER Central Document Room address
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Review Stage Upon receipt and acceptance of Full Qualification Package, QRT
(Stage 2) begins formal review process
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QRT lead and BQP alerts Submitter when final Qualification decision is ready to be rendered
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CDER Center Director renders final qualification decision
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Federal Register notice about the qualification decision is published CDER BQP contact forwards final qualification decision to Submitter in the form of a letter signed by CDER Center Director
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Supporting documentation for qualification decision is posted on FDA website
