Judith A. Arcidiacono, MS U.S. FDA

Judith Arcidiacono M.S. is an International Regulatory Expert and Standards Liaison for regenerative medicine therapies at the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies (OTAT).

Judith has 30 years of experience are FDA. In the first 18 years she served as a research/reviewer conducting research on the human immunological response to xenotransplantation products and reviewed clinical trial applications for NK cell and T cell therapies and xenotransplantation products.

In her current position she works in the Immediate Office of the Director, OTAT, where she is responsible for developing regulatory policy with respect to international harmonization efforts including standards development, and collaborations with global regulatory authorities in the area of regenerative medicine therapies. Ms. Arcidiacono serves on several national and international committees developing standards for regenerative medicine therapies as well as leading international committees focused on harmonization of regulatory approaches for regenerative medicine therapies. Her list of publications include articles and book chapters on her research, FDA policy for standards development and use, and FDA harmonization efforts with international regulators.