MD
Quality Assessment Lead (Acting), OLDP, OPQ, CDER, FDA
Mike has been with the Agency in various roles since 2003. He currently serves as Quality Assessment Lead (acting) in the Office of Lifecycle Drug Products of the FDA. Mike is also actively involved in working groups and expert committees as pertain to guidance and USP monograph developments...
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Vice President, Regulatory Affairs, Generics, North America, Teva Pharmaceutical
Scott D. Tomsky is Vice President, Regulatory Affairs, Generics, North America at Teva. He has been actively involved in the pharmaceutical industry for more than 20 years. Scott has held various positions in R&D, Quality Control and Regulatory Affairs at Johnson and Johnson, Ranbaxy...
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Associate Director for Science, Office of Pharmaceutical Quality, CDER, FDA
Dr. Katherine Tyner is the Associate Director of Science (acting) in the Immediate Office of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research at the United States Food and Drug Administration (FDA). As Associate Director, Dr. Tyner leads the OPQ...
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Chemistry Reviewer, OLDP, OPQ, CDER, FDA
Fang Yuan is a Drug Product Quality Reviewer in Office of Life Cycle Drug Product (OLDP), specialized in pre-market submissions of complex generics including oral inhalation and nasal, and long-acting injectable drug products. She is involved in reviewing pre-ANDA meeting packages...
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Chemist, Office of Lifecycle Drug Products, OPQ, CDER, FDA
Xiaohua serves as a review chemist in the Office of Lifecycle Drug Products of the FDA. His work at FDA involves the quality assessment of abbreviated new drug applications. Prior to joining FDA, he worked in the pharmaceutical industry including Schering-Plough and then Merck on...
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Senior Chemist, OPF, OPQ, CDER, FDA
James Norman is a senior chemist in FDA’s Office of Process and Facilities. He joined FDA in 2015, where he primarily reviews complex combination products such as transdermal systems, intravaginal rings, and microneeedles. He completed his PhD in Chemical Engineering at Georgia...
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