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Navigating and Understanding FDA Review Documents

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Contributors

  • Kunyi Wu, Pharm.D.

    Kunyi Wu, PharmD is a Clinical Pharmacologist in the Office of Clinical Pharmacology at CDER, FDA. Dr. Wu has worked at FDA for five years as a clinical pharmacology reviewer for anti-infective, transplant, ophthalmology products, and submissions under the Animal Rule. Dr. Wu received her Doctor of Pharmacy degree from The Ohio State University and completed her Clinical Pharmacology fellowship training at FDA.

  • J. Russell May, Pharm.D., FASHP

    J. Russell May, Pharm.D., FASHP is a Clinical Professor and Associate Department Head in the Department of Clinical and Administrative Pharmacy at the University of Georgia College of Pharmacy. Prior to his move to academia full time in 2003, Dr. May was a drug information specialist and clinical manager in the Pharmacy Department at the Medical College of Georgia (MCG) Health System for 22 years, including serving as Director of Pharmacy from 1998 – 2003. Since graduating from the University of Kentucky Pharm.D. and Hospital Residency Programs in 1981, Dr. May has focused his practice in the areas of drug information and drug policy development. He currently serves on the Residency Advisory Council for the PGY-1 and three PGY-2 (critical care, oncology, and pediatrics) programs at Augusta University Health System (co-sponsored by the University of Georgia). In 2007, he was named Teacher of the Year at the University of Georgia College of Pharmacy. He is a Fellow of the American Society of Health-System Pharmacists and has served on the ASHP Executive Committee of the Section of Clinical Specialists and the ASHP Commission on Credentialing. He is a past president of the Georgia Society of Health System Pharmacists. Dr. May has served as a visiting professor at Misr International University in Cairo Egypt and assisted with the development of their Drug Information Center, the first in Egypt. Dr. May was the recipient of the 2014 Distinguished Drug Information Practitioner Award from the American College of Clinical Pharmacy Drug Information Practice and Research Network. Dr. May received the 2018 Paul F. Parker Award from the University of Kentucky.

  • Brian Furmanski, Ph.D.

    Dr. Furmanski has over 10 years of experience in the development of small molecule, oligonucleotide, radiopharmaceutical, and biologic therapeutics from an industrial and regulatory perspective. He has provided expert guidance on the design and interpretation of human clinical pharmacology, toxicokinetic, drug metabolism, bioanalytical and biopharmaceutical quality findings through the examination of pharmacokinetic and pharmacodynamic analyses across multiple therapeutic areas.

October 24, 2019
Thu 12:30 PM EDT

Duration 1H 30M

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