Office of Clinical Pharmacology, Center of Drug Evaluation and Research, US FDA

个人简介:Dr. Xinning Yang is a Policy Lead in Guidance & Policy team (GPT) under the Office of Clinical Pharmacology (OCP), CDER of FDA. He received his Ph.D. in Pharmaceutical Science from University at Buffalo, mentored by Dr. Marilyn Morris. Before joining GPT in 2017, he worked as a clinical pharmacology reviewer for 8 years, reviewing a number of IND/NDA submissions and contributing to the benefit/risk assessment of neurology drug products. His current primary focus is guidance and policy development and implementation in various areas, with more focus on drug metabolism, pharmacokinetics, and drug-drug interactions related Clinical Pharmacology issues. He is the Co-Chair of Transporter Focus Group of International Society of Studying Xenobiotics (ISSX), Co-vice chair of the Membrane Transporter (MT) community of the American Society of Clinical Pharmacology and Therapeutics (ASCPT), and a member of International Transporter Consortium (ITC) committee. He is participating in the International Council Harmonization (ICH) M12 DDI guidance global harmonization working group and serves as the Deputy Topic Lead. 查看更多