Office of Translational Sciences
Who We Are
The Office of Translational Sciences (OTS) is composed of four suboffices and the Immediate Office. The OTS Immediate Office supports translational medicine efforts for the Center for Drug Evaluation and Research (CDER) and leads the areas of technology transfer, health information technology, science and research oversight, and knowledge management. OTS also coordinates CDER’s engagement in public-private partnership and consortia activities.
Mission
We empower a collaborative and high performing workforce to champion innovation and advance global human drug development
Vision
Driving advancements in human health through scientific and regulatory innovation
What We Do
- 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.
- Overseeing bioavailability/bioequivalence and non-clinical inspections to help ensure that safe and effective new and generic drugs are available.
- Aligning the research at CDER with the Center's goals.
- Facilitating the establishment of technology transfer agreements for collaboration with the broader scientific community.
- Maintaining knowledge management databases for improvements in the regulatory review process.
Office Organization
- Office of Biostatistics
- Office of Clinical Pharmacology
- Office of Computational Science
- Office of Study Integrity and Surveillance
Contact Us
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