The Office of Translational Sciences (OTS) promotes and protects public health by:
- Promoting scientific collaboration and innovation in drug regulatory review across CDER
- Assuring the validity of clinical trial design and analysis in regulatory decision making
- Developing and applying quantitative and statistical approaches to decision making in the regulatory review process
- Ensuring alignment of CDER research with CDER goals
- Serving the CDER scientific community in establishing technology transfer agreements that are vital to collaboration with the wider scientific community
- Maintaining knowledge management databases that can be the basis of improvements in the regulatory review process
- Overseeing bioequivalence inspections to ensure the availability of safe and effective generic equivalents of investigational drugs
Director: ShaAvhrée Buckman-Garner, M.D., Ph.D.
- The Office of Biostatistics (OB) provides leadership, direction, policy development, and coordination to CDER on statistical, mathematical, and computational aspects of review, evaluation, and research
- The Office of Computational Science (OCS) provides CDER reviewers innovative solutions that improve the scientific drug review process by integrating data, tools, services, and training.
- The Office of Clinical Pharmacology (OCP) assures the safety and effectiveness of new drugs through the evaluation of clinical pharmacology and biopharmaceutics data in support of CDER’s Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) review programs.
- The Office of Study and Integrity and Surveillance (OSIS) ensures data supporting regulatory decisions are reliable by conducting and directing inspections of bioavailability/bioequivalence (BA/BE) and nonclinical (GLP) studies submitted to FDA.
White Oak Building 21 – 4th Floor
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
- Office of Biostatistics
The Biomarker Qualification Program was established to support the Center for Drug Evaluation and Research’s (CDER's) work with external stakeholders to develop biomarkers that aid in the drug development process.
Critical Path Initiative
The Critical Path Initiative (CPI) is FDA's strategy to drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured.
- Critical Path Innovation Meetings (CPIM)
The CPIM is a means by which the Center for Drug Evaluation and Research (CDER) and investigators from industry, academia, patient advocacy groups, and government can communicate to improve efficiency and success in drug development.
- ORISE Fellowship
The ORISE Research Participation Programs at FDA are educational and training programs designed to provide students, recent graduates, and university faculty opportunities to participate in project-specific FDA research and developmental activity
- CDER Regulatory Science Initiatives
Sign up to receive regular updates from CDER on regulatory science opportunities and initiatives.