Addressing the Challenges of Human Tissues and Cell Products Regulation

In 2017, the the New England Journal of Medicine  revealed troubling findings related to clinical studies using stem cells, as reported in the New York Times.   
 
Regulatory oversight of research involving stem cells is tricky. They have a distinct regulatory classification from drugs, biologics, and devices. Read this white paper, authored by WCG experts in ethical review, to learn sponsors, investigators, and IRBs need to know about how these distinct products are regulated.