Analytical science includes the development and use of new and/or uniquely applied methods of analysis like analytical methods development, device failure analysis, drug interaction analysis, epidemiological research, predictive modeling, methods correlation and data analysis, and statistical method development. 

2021

Berkman Sahiner, PhD (CDRH)

For outstanding contributions to the development and performance assessment of computer-aided detection and diagnosis systems in radiology and other medical data applications.

 

2020

Susan Genualdi, PhD

For her outstanding work on the development, validation and implementation of an analytical method for the determination of PFAS chemicals in food products.

 

2019

Nandini Duraiswamy, PhD
For leading a multi-year effort involving diverse stakeholders that improved our understanding of the mechanical performance of transcatheter heart valve replacement devices

 

2018

Berk Oktem, PhD
For developing an analytical test method using mass spectrometry to identify hazardous chemical emissions in vapors and aerosols generated from electronic nicotine delivery systems (e-cigarettes).  

 

2017

Minjun Chen, PhD
For regulatory science contributions towards understanding and screening for drug-induced liver injury in the regulatory environment.

 

2016

Shaun MacMahon, PhD
Specialist in mass spectrometric methods for the analysis of food additives, contaminants, and evidence of economic adulteration in foods.  

 

2015

Zhiwei Zhang, Ph.D., CDRH
For making innovative contributions to many areas in the fields of biostatistics and clinical trials while being a full-time, expert statistical reviewer in CDRH.

 

2014

Telba Z. Irony, Ph.D., CDRH
For spearheading innovative regulatory science studies, culminating in the release of novel guidance documents; supporting complex policy decision-making; and changing the submission review paradigm. 

 

2013  

Jun-Jie Yin, Ph.D., CFSAN
For outstanding work in the development of electron spin resonance (ESR) techniques to understand the formation of free radicals in nanomaterials, cosmetics and dietary supplements.

 

2012
Mikhail Ovanesov, Ph.D., CBER
For laboratory investigation that identified the cause of thromboembolic events in patients receiving immunoglobulin treatments, which led to immediate product withdrawal from the market.

2011 

Hsien-Ming James Hung, PhD, CDER
For sustained excellent achievements to regulatory science in the areas of clinical trial methodology

 

2010 

Sue-Jane Wang, Ph.D., CDER
For a sustained record of published regulatory research in statistical design and methodology advancing complex and emerging clinical trial designs and analysis that support regulatory guidance, policies and review.

 

2009 

Keith Peden, PhD, CBER
For the development of assays for the estimation of the risk posed by residual DNA in vaccines manufactured in neoplastic cell substrates.