About FDA

Office of Translational Sciences

OTS was established to promote efficient and informative study designs and data analysis methods to quantitatively evaluate the efficacy, safety, and dosing of drugs through collaboration among the Office of Biostatistics, Office of Clinical Pharmacology, and other offices in CDER and Centers in FDA. We foster novel drug development strategies through research and application of statistical and mathematical modeling and simulation techniques in the review and analysis of data in the areas of exposure-response, pharmacokinetics, pharmacodynamics, pharmacogenomics, bioequivalence assessment, clinical trials, quantitative risk assessment, toxicology, and product quality assessment.

Highlight specific issues
  • SRIG Report
  • Newly added CDER Guidance documents

Our Mission

The Office of Translational Sciences (OTS) promotes and protects public health by assuring that safe and effective drugs are available to Americans by:
  • Developing and applying quantitative and statistical approaches to decision making in the regulatory review process
  • Assuring the validity of clinical trial design and analysis in regulatory decision making
  • Promoting innovation in drug regulatory review across CDER via Critical Path Initiatives
  • Promoting scientific collaboration to advance regulatory review
  • Ensuring alignment of CDER research with CDER goals

Office Leadership

Director: ShaAvhrée Buckman-Garner, M.D., Ph.D.
Deputy Director: Susan McCune, M.D., M.A.Ed.
Deputy Director for Science: Jan Johannessen, Ph.D.

Contact Us

White Oak Building 21 – 4th Floor 10903
New Hampshire Avenue
Silver Spring, MD 20993-0002
Phone: 301-796-2600
Fax: 301-796-9907


Page Last Updated: 07/16/2015
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