1. CBER's new managed review process: a managed and integrated regulatory process which is continuous from discovery to post marketing;Sensabaugh;Drug Info. J.,1998
2. Public Health Service Act, Chapter 373, Title III, Section 352, 58, Stat. 702, currently codified at 42 U.S.C., Section 262, 1 July 1944. Washington, DC: US Government Printing Office.
3. Food and Drug Administration Modernization Act of 1997, Public Law 105–115, 1997. Washington, DC: US Government Printing Office.
4. Prescription Drug User Fee Act 1992, Public Law 102-571; Prescription Drug User Fee Act Letter, 12 November 1997.
5. US Code of Federal Regulations. Title 21, Parts 312, 600 and 610. Washington, DC: US Government Printing Office, 1999.