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Author Biography
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).

www.americanpharmaceuticalreview.com

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APR September/October 2020

Table of Contents for the Digital Edition of APR September/October 2020
