Do you have questions for the FDA? Would you like to have them answered by a top official of the U.S. Food & Drug Administration?
Peter Marks, director of the FDA Center for Biologics Evaluation and Research (CBER), will welcome your questions as part of the President’s Session at 8:30 am Saturday, Sept. 10, at the Cord Blood Connectˆ international congress.
Click this link to submit one or more questions. CBA President Joanne Kurtzberg will prioritize the questions so that as many as possible can be answered in a half hour. The “Ask FDA” period will follow Dr. Marks’ presentation on “FDA Guidance for Gene and Cell-Based Therapies for Ultra Rare Diseases.”
Dr. Marks is a hematologist/oncologist who has held the top position in CBER since his appointment to the position in 2016. The center is responsible for the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue and gene therapies.
He has addressed each Cord Blood Connect international congress, both in-person and virtual , since they began in 2018.