Stem cell regulations are under the spotlight. Can we expect changes into 2027? Stem cells are currently regulated under Section 361 if they meet all the standards for 361 stem cell and other human cells, tissues, and cellular and tissue-based products (HCT/Ps), including minimal manipulation and homologous use requirements. Products classified under Section 351 are subject to a different regulatory framework. We’re following several discussions, legal cases, and FDA/HHS dockets related to HCT/Ps. 

Read More