FDA Guidance and Regulatory Updates (Individual)

In this presentation, AATB is joined by Safa Karandish is a Consumer Safety Officer with FDA’s Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies in the Division of Human Tissues, to discuss updates and changes to regulations and guidance surrounding donated HCT/Ps.

Safa Karandish, B.S., MT

Consumer Safety Officer, Division of Human Tissues

Safa Karandish is a Consumer Safety Officer with FDA’s Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies in the Division of Human Tissues. She joined FDA in 2010, with over 24 years of experience in cellular therapy manufacturing in academic centers and medical device companies. Her primary focus in the Division of Human Tissues is on activities related to policy, regulations, and review of human cell and tissue products.