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Jinjie Hu

Biologics Consulting Group
co-chair of FDAAA International Network committee; Senior Consultant
Dr. Hu received her Ph.D. in Comparative Pathology from UC, Davis, followed by postdoctoral fellowship at the NIAID, NIH. She worked at FDA for almost 12 years where she is recognized as the IVD expert on FDA regulation and QSR requirement. She chaired many review committees for 510 (k), IDE, PMA, IND and BLA. She also taught the Medical Device Training at CEBR/FDA. She is the co-chair of FDA Alumni Association International Committee and serve as Adviser for WHO Prequalification Program.

My Chair Sessions

Wednesday, June 29