Policy Lead
US Food and Drug Administration
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. In the past, as a clinical pharmacology reviewer, he reviewed a number of IND/NDA submissions 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), a member of Regulatory Affair committee of ISSX, 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. He published more than 20 peer-reviewed articles in journals and book chapters, made a number of presentations at different meetings, and also hosted/chaired symposiums or workshops at conferences.
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Thursday, March 17, 2022
12:15 PM – 1:15 PM ET
Monday, April 25, 2022
8:00 AM – 1:30 PM ET
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