Lei Zhang, PhD
Deputy Director, ORS, OGD, CDER
ORS implements the Generic Drug User Fee Amendments (GDUFA) science and research commitments to ensure the therapeutic equivalence of generic drug products. ORS also provides pre-submission scientific advice on equivalence standards to abbreviated new drug applications (ANDA) applicants through meetings, guidances, and controlled correspondences. Dr. Zhang is an accomplished professional with more than 23 years of combined experiences in the areas of drug research, development and regulatory review and approval. She has contributed to numerous guidance development and research projects focused on the science-based regulatory decision-making. Before joining FDA in 2002, she worked at Bristol-Meyers Squibb Company as a Research Investigator and Preclinical Candidate Optimization Team Leader. Dr. Zhang is an Adjunct Professor in the Department of Bioengineering and Therapeutic Sciences, University of California at San Francisco, Schools of Pharmacy and Medicine. Dr. Zhang received her Ph.D. in Biopharmaceutical Sciences from UCSF. She was a member of the ICH Generic Drug Discussion Group (GDG), serving as the U.S. FDA Topic Leader. Additionally, she is the Rapporteur for ICH M13 Informal Working Group that is developing M13 guideline to harmonize bioequivalence (BE) study design for immediate-release oral dosage form drugs. Dr. Zhang was named American Association of Pharmaceutical Scientists (AAPS) Fellow in 2013. Dr. Zhang has published more than 120 journal articles and book chapters.