A14 - FDA and the Center for Biologics Evaluation and Research's (CBER) Regulation of Biological Products, Including Regenerative Medicine Therapies

This session will introduce the audience to how different types of biological products are regulated by FDA CBER. The presentation will include a discussion of FDA’s regulatory framework for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), including when you need an investigational new device. The session will also cover the marketing of unapproved regenerative medicine therapies for which studies have not been done to demonstrate safety and effectiveness. The session will include an IRB representative who will discuss how an IRB might analyze regenerative medicine therapy submissions.