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Pig Genetic Engineering: Regulation and Clinical Trials

Friday September 24, 2021 - 22:25 to 23:30

Room: General Session

210.2 The FDA perspective

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Judith A. Arcidiacono, United States

International Regulatory Expert
Office of Tissues and Advanced Therapies
Center for Biologics Evaluation and Research

Objectives

RECOMMENDED MATERIAL:

Advice to developers: Early interactions with the FDA can help avoid costly mistakes.
Email: ASKCVM@fda.hhs.gov  or  OTATRPMS@fda.hhs.gov

FDA Resources for Regulation of Xenotransplantation Products and Contact Information

Presentations by Judith A. Arcidiacono