References
- "Reinventing the Regulation of Human Tissue". Vice President's National Performance Review Report. February 1997.
- Proposed Approach to Regulation of Cellular and Tissue-based Products — 2/28/97: http://www.fda.gov/cber/ gdlns/CELLTISSUE.pdf and "A Proposed Approach to the Regulation of Cellular and Tissue-based Products". March 4, 1997,62 FR 9721.
- Human cells, tissues and cellular and tissue-based products; establishment registration and listing final rule. Fed Reg 2001;66:5447-69. Available at http://www.fda.gov/cber/ rules/frtisreg011901.htm visited 19th July 2002.
- Suitability determination for donors of human cellular andtissue-based products. Fed Reg1999;64:52696.
- Current good tissue practice for manufacturers of humancellular and tissue-based products; inspection and enforce-ment; proposed rule. Fed Reg 2001;66:1508.