1. First biopharmaceuticals approved in the U.S.: 1980—1994;Gosse;Drug Inf. J.,1996
2. Prescription Drug User Fee Act of 1992. US Public Law 102-571 (1992 Oct 29); 21 USC 379; 106 Stat 4491
3. Food and Drug Administration Modernization Act of 1997. US Public Law 105-115 (1997 Nov 21); 21 USC 355a; 111 Stat 2296
4. Fourth Annual Performance Report: Prescription Drug User Fee Act of 1992. FY 1996 Performance Report to Congress (Dec 1996), US Food and Drug Administration, Rockville, MD, USA
5. Final Performance Report: Prescription Drug User Fee Act of 1992. Fiscal Year 1997 Report to Congress (Dec 1997), US Food and Drug Administration, Rockville, MD, USA