Dr. Huiquan Wu received his Ph.D. in Chemical Engineering with a minor in Materials Science and Engineering from Iowa State University in 2001. Dr. Wu worked as a senior process development engineer at LSI Logic and ACM Research from March 2001 to August 2002. Since joining FDA in August 2002,
Dr. Wu has been worked as a visiting associate (August 2002-March 2005), staff fellow (March 2005-December 2011), and research chemical engineer (January 2012-present) at various quality areas within the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), including Office of Pharmaceutical Sciences (OPS) PAT Policy and Research Development Team (August 2002-March 2005), Office of Testing and Research (OTR) Division of Product Quality Research (DPQR) (March 2005-Juanary 2015), Office of Process and Facilities (OPF) Division of Process Assessment 1(DPA 1) (January 2015-October 2019), and then Office of Pharmaceutical Manufacturing Assessment (OPMA) Division of Pharmaceutical Manufacturing I (DPM I) (October 2019-present). Since joining OPF/ OPMA in January 2015, Dr. Wu has been conducted primary regulatory and scientific assessment of NDAs/ANDAs/INDs/NDA Supplements/ANDA Supplements. (NDA: New Drug Application; ANDA: Abbreviated New Drug Application; IND: Investigational New Drug Application).
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