FDA | Biologics Effectiveness and Safety (BEST)

Tissues & Advanced Therapeutics

Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. The Center for Biologics Evaluation and Research (CBER) regulates HCT/Ps under 21 CFR Parts 1270 and 1271. Examples of such tissues are bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes and semen.

CBER regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. Cellular therapy products include cellular immunotherapies, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications, including hematopoetic stem cells and adult and embryonic stem cells. Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.

Most Recent Tissues & Advanced Therapeutics Assessments



Assessment of Immunoglobulin Utilization and Shortage

IG Utilization Protocol 2020 (pdf)

The Assessment of Immunoglobulin Utilization and Shortage Protocol was finalized 8/ 31/2020. A final report, Assessment of Immune Globulin Utilization in Commercially insured and Medicare Populations, for this protocol was added February 2022.


Immunoglobulin, Shortage, Subcutaneous