Developing and sharing knowledge with researchers from the public and private sectors is at the heart of what Center for Drug Evaluation and Research (CDER) scientists do. The tools and resources that are currently available are listed below. Please check back for updates.
- Drug Development Tool Qualification Programs
- Drug-Related Guidance Documents
- Information About Emergency Preparedness, Drug Safety and Availability, and FDA Advisory Committees
- Recent Reports on Regulatory Science
- Research Capabilities
- Scientific Publications by FDA Staff
- Table of Pharmacogenomic Biomarkers in Drug Labeling
- CTB2 Biorepository
- Read about how the TB Biorepository aims to bolster development of drugs to treat tuberculosis by facilitating research on biomarkers.
- Drug Approvals and Databases
- FDA Adverse Event Reporting System
- Mortara/FDA ECG Warehouse
- Read about how FDA scientists are streamlining clinical trials by finding better ways to assess the risk drugs pose to the heart.
- UCSF-FDA TransPortal
Drug Development Tool Qualification Programs
CDER's Drug Development Tool (DDT) Qualification Programs allow CDER to work with submitters to guide them as they develop DDTs for specific contexts of use. CDER has programs directed toward the following DDTs:
- Animal Model Qualification Program
- Biomarker Qualification Program
- Clinical Outcome Assessment Program
Drug-Related Guidance Documents
FDA guidance documents represent FDA's current thinking on a particular subject.
- Browse all of CDER's guidance documents by topic.
- See CDER's most recently added guidance documents.
Recent Reports on Regulatory Science
- Drug Safety-Related Regulatory Science Needs and Priorities
- FY 2015-2016: Regulatory Science Progress Report (PDF - 1.4 MB)
- CURE ID App
- FDA’s MyStudies Application (App)
- Office of Computational Science tools for CDER reviewers
Scientific Publications by FDA Staff
CDER scientists frequently share their research findings in scientific journals. Search the database of scientific publications by FDA staff.
Table of Pharmacogenomic Biomarkers in Drug Labeling
The Table of Pharmacogenomic Biomarkers in Drug Labeling is a list of FDA-approved drugs whose labels include pharmacogenomic information. Pharmacogenomics can help identify who will respond to medications, avoid adverse events, and optimize drug doses. Some of the products' labels include specific actions to be taken based on biomarker information.