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Mar 7 2023

The FDA & Biotechnology section’s Barbara Binzak Blumenfeld presented a session on March 7 as part of the Food and Drug Law Institute’s Introduction to Biological Products course. Barbara’s presentation on cell and gene therapy approvals highlighted FDA’s regulatory framework, developmental and regulatory challenges, and recent enforcement actions. The audience included individuals from industry, the National Cancer Institute, and FDA’s Office of the Commissioner.

Founded in 1949, FDLI is a nonprofit membership organization offering education and professional engagement opportunities in food and drug law, and provides a venue for stakeholders to engage and innovate.