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The Role of CBER in Biologics Regulation
The regulatory landscape surrounding biologics and cellular therapies in the United States continues to evolve at a rapid pace. As regenerative medicine advances from experimental research into mainstream clinical practice, understanding how the Food and Drug Administration (FDA) oversees these products has become essential for healthcare professionals, distributors, and educators alike.
The Center for Biologics Evaluation and Research (CBER), a division of the FDA, serves as the primary regulatory authority for cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER operates under two key enabling statutes: the Public Health Service Act (PHSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Cellular therapy products regulated by CBER encompass a broad range of biological materials, including cellular immunotherapies, cancer vaccines, and both autologous (self-derived) and allogeneic (donor-derived) cells for specific therapeutic indications. These include hematopoietic stem cells as well as adult and embryonic stem cells used in various clinical applications.
Understanding the 351 and 361 Regulatory Pathways
One of the most important distinctions in biologics regulation involves the difference between products regulated under Section 351 and Section 361 of the Public Health Service Act.
Section 351 products are biological products that require premarket approval through a Biologics License Application (BLA). These products undergo rigorous clinical trials to demonstrate safety, purity, and potency before they can be marketed.
Section 361 products, also known as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), are regulated under a less stringent framework. To qualify under Section 361, products must meet specific criteria outlined in 21 CFR Part 1271, including minimal manipulation, homologous use, and other requirements.
The Evolving Regulatory Landscape in 2026
The FDA has demonstrated increasing flexibility in its approach to cell and gene therapy regulation. In January 2026, the agency announced updated guidelines aimed at increasing flexibility on Chemistry, Manufacturing, and Controls (CMC) requirements for cell and gene therapies, recognizing the unique challenges these innovative products present compared to traditional pharmaceuticals.
Why Regulatory Education Matters
For healthcare professionals working with biologics, understanding the regulatory framework is not optional — it is a fundamental requirement for compliant practice. Proper regulatory education helps practitioners distinguish between FDA-approved products and those still under investigation, understand compliance requirements for handling biological products, and navigate the complex landscape of state and federal regulations governing regenerative medicine.
Cellovian’s Commitment to Regulatory Education
At Cellovian, we believe that advancing regenerative medicine begins with education. Our scientific and regulatory education programs are designed to equip healthcare professionals with the knowledge they need to navigate the biologics landscape with confidence.
This article is provided for educational purposes only and does not constitute medical or legal advice. Healthcare professionals should consult with qualified regulatory counsel for guidance
specific to their practice.
Scientific References
1. U.S. Food and Drug Administration. “About the Center for Biologics Evaluation and Research (CBER).” FDA.gov. Available at: https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber
2. U.S. Food and Drug Administration. “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.” Guidance for Industry, 2020.
3. U.S. Code Title 42, Chapter 6A, Subchapter II, Part F. “Regulation of Biological Products (Section 351 of the Public Health Service Act).”
4. Code of Federal Regulations, Title 21, Part 1271. “Human Cells, Tissues, and Cellular and Tissue-Based Products.”
5. Marks, P.W., Witten, C.M., and Califf, R.M. “Clarifying Stem-Cell Therapy’s Benefits and Risks.” New England Journal of Medicine, 376(11), 1007-1009, 2017. DOI: 10.1056/NEJMp1613723
6. U.S. Food and Drug Administration. “Framework for the Regulation of Regenerative Medicine Products.” FDA.gov, 2017.