Biomarkers at CDER
Announcement
New! Change in Process for Qualification of Drug Development Tools
Get updates and details.
Learn More
- Watch and learn about the Biomarker Qualification Program.
- Watch other videos about FDA’s Biomarker Qualification Program
- Explore fictional case studies with “real-world” examples to learn more about biomarkers and biomarker qualification in drug development
For more information about biomarker activities at CDER:
- Current Biomarker Submissions
- FDA-Qualified Biomarkers
- Biomarker Survey Results
- Biomarker Used as Outcomes in Development of FDA-Approved Therapeutics (October 2007-December 2015)
- Active DDT Projects
Current Biomarker Submissions
The Biomarker Qualification Program encourages requestors who have a biomarker qualification project accepted into the Program to voluntarily provide general information about their project and contact information. Learn more about the current Biomarker Qualification Submissions.
FDA-Qualified Biomarkers
Take a look at the FDA-Qualified Biomarkers to see the list of qualified biomarkers with their qualification-specific guidances and reviews.
Biomarker Survey Results
The Biomarker Survey Results webpage identifies potential biomarkers for qualification.
Biomarkers Used as Outcomes in Development of FDA-Approved Therapeutics (October 2007-December 2015)
The Biomarkers Used as Outcomes in Development of FDA-Approved Therapeutics (October 2007- December 2015) provides examples of biomarkers—categorized by therapeutic areas—that were accepted and used as outcomes in clinical trials as the basis for drug and biologic approvals from October 2007 to December 2015. A biomarker may have been used to support approval of multiple drugs or biologics.
Active DDT Projects
The Drug Development Tool (DDT) Qualification Projects at CDER webpage lists the statistics and status of the current DDT projects.