Sterility Assurance Applied to Stem Cell Therapies

Abstract
Stem cell therapies are becoming more important in the pharmaceutical industry. The genetic manipulations of the cells involved create a powerful tool to treat serious diseases, such as cancer. In 2017, the Food and Drug

• Administration (FDA) made several advancements towards regulation of stem cell therapy:
• Published perspective on stem cell therapy in the New England Journal of Medicine
• Increased regulation enforcement for stem cell clinics
• Released new guidance, Regulatory Consideration for Human Cells, Tissues, and Cellular and TissueBased Products: Minimal Manipulation and Homologous Use

To regulate this industry, the FDA uses a risk-based enforcement approach with considerations for how and why the products are used. FDA`s discretion for how regulations will be enforced ends November 2020. Companies responsible for ensuring full compliance should contact the FDA before the cutoff to remove uncertainty regarding the regulatory status of their products and to determine whether the products are subject to premarket approval. FDA guidances are intended to help bring innovative, safe, and effective products to patients as efficiently as possible.