FDA, cell therapies and genomic data
The U.S. Food and Drug Administration (FDA) regulates stem cell therapies as biological products to ensure their safety and efficacy. The FDA requires that stem cell therapies undergo rigorous clinical trials to demonstrate safety and effectiveness before approval. Patients considering stem cell treatments should consult with their healthcare providers about FDA-approved options and be cautious of unproven therapies that have not undergone proper regulatory review. The Complete Baseline is a wellness record reviewed by a board-certified physician partner. It is not a diagnosis.