Abstract
The regulatory climate surrounding cord blood banking has been slowly evolving since the publication of the FDA notice, Applications of Current Statutory Authorities to Human Somatic Cell Therapy in the October 14, 1993, Federal Register. The pace of establishing regulatory policy for cord blood banking is about to quicken dramatically. Cord blood banking will most likely be regulated as a new blood product within the Office of Blood Research and Review in the Center for Biologics Evaluation and Research (CBER) and would then be subject to licensing preapproval inspections. Validation is a critical element of the approval process. Fundamental elements of structuring and implementing a scientifically sound validation program are discussed.
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