Who we are:
The Office of Translational Sciences (OTS) is composed of five offices with 22 divisions. The OTS Immediate Office supports translational medicine efforts for CDER and leads the areas of technology transfer, data mining, health information technology, science and research oversight, and knowledge management. OTS also administers CDER’s Oak Ridge Institute for Science and Education (ORISE) Program through its Office of Administrative Operations.
We empower a diverse, collaborative and high performing workforce to champion innovation and advance global human drug development.
Driving advancements in human health through scientific and regulatory innovation
What we do:
- Promote scientific collaboration and innovation in drug regulatory review across CDER.
- Assure the validity of clinical trial design and analysis in regulatory decision-making.
- Develop and apply quantitative and statistical approaches to decision making in the regulatory review process.
- Ensure alignment of CDER research with CDER goals.
- Serve the CDER scientific community in establishing technology transfer agreements that are vital to collaboration with the broader scientific community.
- Maintain knowledge management databases that can be the basis of improvements in the regulatory review process.
- Oversee bioavailability/bioequivalence and non-clinical inspections to help ensure the availability of safe and effective new and generic drugs.
- Office of Administrative Operations
- Office of Biostatistics
- Office of Clinical Pharmacology
- Office of Computational Science
- Office of Study Integrity and Surveillance
E-mail: CDEROTSFeedback@fda.hhs.gov | Phone: 301-796-2600 | Fax: 301-796-9907
Office of Translational Sciences
White Oak Building 21
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Resources For You
- Office of Translational Sciences 2022 Annual Report
- Critical Path Initiative
- Critical Path Innovation Meetings (CPIM)
- ORISE Fellowship