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.
- SRIG Report
- Newly added CDER Guidance documents
- 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
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.
White Oak Building 21 – 4th Floor 10903
New Hampshire Avenue
Silver Spring, MD 20993-0002