2023 AOSSM Annual Meeting Recordings with CME-FDA's Regenerative Medicine Framework

Video Transcription

Video Summary

In this video, a representative from the government explains the regulations surrounding human cells, tissues, and tissue products. Genetically modified cells are considered biologic products and are regulated under drug applications and biologics license applications. Platelet-rich plasma, on the other hand, is a blood product and is regulated separately. The FDA's goal is to ensure safety and effectiveness, and they regulate products with the lowest level of regulation necessary. Some products, like skin grafts and bone grafts, have specific requirements to prevent infectious disease transmission. The FDA also has a compliance function to prevent scams and ensure people receive genuine therapies. They aim to continue advancing products in the orthopedic space. No credits are granted.

Asset Caption

Peter Marks, MD, PhD

Keywords

government regulations

biologic products

FDA regulations

safety and effectiveness

orthopedic products