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.
Naomi L. Kruhlak, PhD (CDER)
For advancing the regulatory science and application of (Q)SAR modeling for decision-making in the safety and quality review of new and generic drugs.
Jana Katherine McAninch, MS, MPH, MD (CDER)
For excellence in leading a multidisciplinary team and in developing an innovative and scientifically meaningful review strategy for ADF OxyContin that included public health impact.
Frank W. Samuelson, PhD
For outstanding and creative contributions to review science in CDRH, lending confidence to the premarket evidence requirements for emerging medical imaging systems.
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.