1. CBER Vision: 2004, Center for Biologics Evaluation and Research Strategic Planfor2004. Rockville, MD: Food and Drug Administration; August 14, 1995.
2. Food and Drug Administration Modernization Act of 1997. Pub law 105-115 (1997 Nov 21).
3. Prescription Drug User Fee Act of 1992. Pub law 102-571 (1992 Oct 29); 21 USC 379; 106 Stat 4491.
4. Sensabaugh SM. A Primer on CBER’s Regulatory Review Structure and Process. Drug Inf J. 1998;32(4).