Chana Fuchs is a Team Leader in Division IV in the office of biotechnology products (OBP) at FDA’s Center for Drug Evaluation and Research (CDER), FDA. Dr. Fuchs joined the FDA in 1995 as a research fellow, and has been a reviewer of biotechnology products since 1998. Her responsibilities at FDA have included the review of the chemistry, manufacture, and control (CMC) and immunogenicity information submitted with investigational new drug and biologics licensing applications and related amendments, and supplements, and participation in pre-license, pre-approval and GMP inspections. Dr. Fuchs has also been involved in the development of regulatory guidance and policy. Dr. Fuchs and members of her team are currently reviewing biotechnology product submissions that are under various expedited pathways as well as submissions for biosimilar products.