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Judith Arcidiacono, MS

Advanced Therapies Regulatory Expert
US Food and Drug Administration

Judith Arcidiacono is an International Regulatory Expert at the FDA Office of Therapeutic Products, in the Center for Biologics Evaluation and Research. She leads the International Pharmaceutical Regulatory Programme (IPRP) Cell and Gene Therapy Working Group and represents the working group in the ICH Cell and Gene Therapy Discussion Group. She is also the co-champion of the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee (APEC RHSC), Priority Work Area (PWA) on Advanced Therapies and Biotherapeutics. In addition, Judith leads the Standards Development Program for Regenerative Medicine Therapies (RMT), is chair of the CBER Standards Recognition Program for RMT. She represents FDA in the International Organization for Standardization (ISO) TC 276 Biotechnology, and the American Society for Testing and Materials international (ASTM) Committee on Tissue Engineered Medical Products..

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