Science & Research

Excellence in Analytical Science 2009-Present

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. 

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.
 

Page Last Updated: 08/20/2018
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