Status of Biomarker Qualification Submissions
The CDER & CBER DDT Qualification Project Search database was implemented to meet the requirements of the transparency provisions of the 21st Century Cures Act and enable public stakeholders to search across Drug Development Tool (DDT) programs by stage of submission, qualification status, disease and therapeutic area.
The 21st Century Cures Act transparency provisions require that FDA make publicly available and update on a biannual basis, information with respect to each DDT qualification submission. This requirement applies to Letters of Intent (LOIs), Qualification Plans (QPs), and Full Qualification Packages (FQPs) sent to FDA after December 13, 2016 (when the 21st Century Cures Act was enacted). The FDA also enters information about Letters of Support issued to requestors.
The CDER & CBER DDT Qualification Project Search includes legacy projects (those submitted prior to enactment of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and Cosmetic Act (FD&C Act), which was created by Section 3011 of the 21st Century Cures Act).
Access the full database:
CDER & CBER DDT Qualification Project Search
To view the status of biomarker submissions, a full list of qualified biomarkers, and Letters of Support (LOS) issued by the Biomarker Qualification Program, go to the CDER & CBER DDT Qualification Project Search database and perform one of these example queries:
To search for biomarker qualification submissions currently under development, go to the CDER & CBER DDT Qualification Project Search database and search by keyword(s). You may also search by relevant criteria such as “Program”, “Stage”, “FDA Determination”, “Disease or Condition”, “Therapeutic Area”, “Requestor Organization Name”, or “Project Number” (e.g., DDTBMQ-000000). Click on the “Search” button.
To view a full list of qualified Biomarkers, go to the CDER & CBER DDT Qualification Project Search database and select the following: “Program → BMQ - Biomarkers”, “Stage → FQP - Full Qualification Package”, and “FDA Determination → Qualified”. Click on the “Search” button.
Letters of Support sent to FDA after December 13, 2016 (when the 21st Century Cures Act was enacted) are viewable on the CDER & CBER DDT Qualification Project Search database. To access the list, select the following: “Program → BMQ - Biomarkers”, “Stage → LOS - Letter of Support”, and “FDA Determination → Issued/Not Issued”. Click on the “Search” button.
The FDA makes no representations, guarantees, or warranties as to the accuracy, completeness, currency, or suitability of the information in submissions. See the FDA decision letter corresponding to each submission for FDA considerations and recommendations related to each request for qualification. Information submitted to the agency by outside parties requesting qualification of a DDT is not an endorsement or recommendation by FDA of the tool’s use.
For general questions about the CDER & CBER DDT Qualification Project Search database, please contact the Biomarker Qualification Program at [email protected].
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