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.