FDA Sets Regulatory Framework for Regenerative Biological Therapies via Cosmetics and Toiletries
22 November 2017
The U.S. Food and Drug Administration (FDA) announced it has completed a final and comprehensive framework to oversee regenerative medical products, including cellular therapies. The cosmetics industry has leveraged these technologies as well, and as medicine and cosmetic treatments become more “personal” in nature, it will be all the more important the industry is aware of where the FDA draws the line for use of these materials.
According to the FDA, the new framework builds upon an existing risk-based regulatory approach in order to clearly describe what products are regulated as drugs, devices and/or biological products.