Policy Lead
Food and Drug Administration, Maryland
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 numerous 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 areas of drug metabolism, pharmacokinetics, drug-drug interactions, and drug-food interactions related Clinical Pharmacology issues. He is also active in research and led or co-led multiple research projects funded internally. He is the Co-Chair of Transporter Focus Group of International Society of Studying Xenobiotics (ISSX), a member of ISSX Regulatory Affair committee, 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 from FDA.
Disclosure information not submitted.
Wednesday, October 19, 2022
3:30 PM – 4:00 PM ET