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Office of Translational Sciences

Office of Translational Sciences

Who we are:

The Office of Translational Sciences (OTS) is composed of multiple offices. 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 their Program Management and Analysis Staff.

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.
  • Serve the CDER scientific community by establishing technology transfer agreements that are vital to collaboration with the wider scientific community.
  • Maintain knowledge management databases that can be the basis of improvements in the regulatory review process.
  • Oversee bioequivalence inspections to ensure the availability of safe and effective generic equivalents of investigational drugs.
  • OTS Flyer (PDF - 3 MB)

Office Organization:

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