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  1. About Science & Research at FDA

Excellence in Review Science 2009--Present

Review science includes new and/or uniquely applied approaches to regulatory decision-making and the ability to interpret scientific information submitted to the Agency, for example, application of scientific expertise to the review process, national and international standards development and harmonization, and development of regulatory policies and guidance

Subha Maruvada, PhD
For proven leadership at the International Electrotechnical Commission and the Acoustical Society of America, bringing ultrasonic characterization methodology to world harmonization

Jin Young K. Park, PhD, MPH

For excellence and innovative risk and analytical skills used to demonstrate and quantify the coronary heart disease risk associated with the consumption of industrial-produced trans fats (iTFA) in partially hydrogenated oils that are used in foods.

Anthony Parker, PhD

For outstanding statistical and scientific contributions in the use of alternative statistical designs and meta-analyses for the approval of new animal drugs. 

Maria Teresa Gutierrez Lugo, PhD

For the critical and insightful evaluation of the analytical and functional data that formed the foundation for approval of the first bio similar BLA

Ted Guo, Ph.D., CDER

For the development of the powerful diagnostic tool, eDISH (evaluation of drug-induced serious hepatotoxicity), widely used by industry, academia, and OND reviewers. Now developing more powerful upgrade eDISH2.

Eric Donaldson, PhD, CDER

For initiating collaborations with CDER, CDRH, and CBER to facilitate next-generation sequencing analysis review of viral resistance data for two high-priority New Drug Applications

Margaret Bash, MD, CBER

For outstanding work in the application of first hand scientific knowledge of meningococcal serological assays to the review and licensure of meningococcal vaccines.

Rita Ouellet-Hellstrom, Ph.D., M.P.H., CDER

For innovation and persistence in reviewing the safety of new generations of contraceptives and finding creative ways for estimating true risks among product users

Andrew Dayton, Ph.D., CBER

For outstanding leadership in the development and application of quantitative risk models of behavior‐based blood donor deferral policies

Richard P. Felten, M.S., CDRH

For exemplary scientific contributions in the area of fraxel and fractionated laser light with dermal tissues and applying expertise to the review process

Xuefeng Li, PhD, CDRH

For developing new methods and improving established techniques to address pressing analytical issues encountered in the design and analysis of Bayesian Adaptive Clinical Trials


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