Proposed Approach to Regulation of Cellular and Tissue-Based Products

摘要

The Food and Drug Administration is proposing a new approach to the regulation of211u001ehuman cellular and tissue-based products. The new regulatory framework, as 211u001earticulated in this document, would provide a unified approach to the regulation 211u001eof both traditional and new products. The framework clearly specifies criteria 211u001efor regulation, and would provide for harmonized review of applications by 211u001edifferent Centers within the agency. Additionally, the framework would provide 211u001eonly the degree of government oversight necessary to protect the public health. 211u001eFor products with limited public health concerns, the new framework would allow 211u001eflexibility and innovation without an application review process.