Final Report of the Advisory Committee on the Food and Drug Administration. Washington DC: Department of Health and Human Services, Advisory Committee on the Food and Drug Administration. May 1991:1. Edwards Committee.
2.
HuttPB. Investigations and reports respecting FDA regulations of new drugs (Part I). Clin Pharmacol Ther.1983;33(4):537.
3.
HuttPB. Progress in new drug regulation. Clin Res Prac Drug Reg Affairs.1987;5(5&6):310.
4.
HuttPB. Investigations and reports respecting FDA regulation of new drugs (Part II). Clin Pharmacol Ther.1983;33(5):674.
5.
Commission on the Federal Drug Approval Process, final report. Prepared by the Subcommittee on Natural Resources, Agriculture Research, and Environment and the Subcommittee on Investigations and Oversight. Transmitted to the Committee on Science and Technology, U.S. House of Representatives, October, 1982. Washington DC: US GPO, 1982. (McMahon Commission).
6.
Remarks by the Honorable Richard S. Schweiker to the National Pharmaceutical Council Symposium, June 23, 1982. U.S. Department of Health and Human Services. HHS Fact Sheet: new drug approval reforms. June 23, 1982. (Hayes/HHS Fact Sheet).
7.
Proposed revision of IND/NDA regulations. Washington, DC: Pharmaceutical Manufacturers Association, April 15, 1982.
8.
FDA's reviews of new drugs: changes needed in process for reviewing and reporting on clinical studies. United States General Accounting Office (GAO/HRD-88-100). Washington DC: GPO, September 1988.
9.
FDA resources: comprehensive assessment of staffing, facilities, and equipment needed. United States General Accounting Office (GAO/HRD-89-142). Washington, DC: GPO, September 1989.
10.
Final report of the National Committee to Review Current Procedures For Approval of New Drugs For Cancer and AIDS. Bethesda, MD: National Cancer Institute, August 15, 1990. (Lasagna Committee).
11.
Improving the nation's drug approval process. Council on Competitiveness. Washington, DC: Office of the Vice President. November 13, 1991. (Quayle Council).
12.
One year later: A report of members of the 1991 Advisory Committee on the Food and Drug Administration. June 29, 1992.
13.
Food and Drug Administration advisory committees.Institute of Medicine, Committee to study the use of advisory committees by the Food and Drug Administration. Edited by RettigRAEarleyLEMerrillRA. Washington, DC: National Academy Press; 1992.
14.
Policy and guidance handbook for FDA Advisory Committees. Bethesda, MD: Food and Drug Administration; 1994.
15.
KesslerDA. Informal remarks to the National Cancer Advisory Board, Bethesda, Maryland, January 27, 1992.
16.
U.S. and Canadian drug regulators move to streamline IND requirements.U.S. Regulatory Reporter.1994; Apr 10(10):4–6.
