Tobacco Documents Online

• • GAO Reports on FDA-Related Topics 1986 to Present Food and Drug Administration: Interstate Milk Shippers Program HRD-86-54FS, December 20, 1986 Food Inspections: FDA Should Rely More on State Agencies HRD-82-2, February 18, 1986 Food and Drug Administration: Six Former HHS Employees' Involvement in Aspartame's Approval HRD-86-109BR, July 22, 1986 Food and Drug Administration: Resources for Division of Scientific Investigations Have Been Reduced HRD-86-136FS, August 28, 1986 Pesticides: FDA's Investigation of Imported Apple Juice Concentrate RCED-86-214FS, August 29, 1986 Drug Regulation: FDA's Computer Systems Need To Be Better Managed IMTEC-86-32, September 5, 1986 Food and Drug Administration: Laboratory Analysis of Product Samples Needs To Be More Timely HRD-86-102, September 30, 1986 Pesticides: Need To Enhance FDA's Ability To Protect the Public From Illegal Residues RCED-87-7, i1Zd October 27, 1987 ~ ~ ~ C.~ ~:

2 • • Food and Drug Administration: Food Additive Approval Process Followed for Aspartame HRD-87-46, June 18, 1987 ADP Procurements: Food and Drug Administration Circumvented Procurement Regulations IMTEC-87-48 September 11, 1987 Food Marketing: Frozen Pizza Cheese--Representative of Broader Food Labeling Issues GAO/RCED-88-70 March 31, 1988 Food and Drug Administration: HHS Inspector General Should Be Involved in Criminal Investigations GAO/HRD-88-8 November 4, 1988 Food and Drug Administration: Insufficient Planning for Field Laboratory Consolidation Decisions GAO/HRD-88-21 December 4, 1988 Medical Devices: FDA's Forecasts of Problem Reports and FTES Under H.R. 4640 GAO/PEMD-88-30 July 11, 1988 Seafood Safety: Seriousness of Problems and Efforts to Protect Consumers GAO/RCED-88-135 August 10, 1988 Medical Devices: FDA's 510(k) Operations Could Be Improved GAO/OPEMD-88-14 August 17, 1988 ~ O ~ ~ . ~ ~

3 • • FDA's Reviews of New Drugs: Changes Needed in Process for Reviewing and Reporting on Clinical Studies GAO/HRD-88-100 September 12, 1988 ADP Systems: FDA Can Reduce Development Risks for Its Import Information System GAO/IMTEC-88-42 September 30, 1988 Medical Devices: FDA's Implementation of the Medical Device Reporting Regulation GAO/PEMD-89-10 February 17, 1989 ADP Planning: FDA's Plans to Improve Processing of Medical Device and Drug Applications GAO/IMTEC-89-58 June 13, 1989 Medical Device Recalls: An Overview and Analysis 1983-88 GAO/PEMD-89-15BR August 30, 1989 FDA Resources: Comprehensive Assessment of Staffing, Facilities, and Equipment Needs GAO/HRD-89-142 September 15, 1989 Domestic Food Safety: FDA Could Improve Inspection Program to Make Better Use of Resources GAO/HRD-89-125 September 27, 1989 Food Safety: Issues USDA Should Address Before Ending Canadian Meat Inspections GAO/RCED-90-176 July 6, 1990 b ~ CS~ CO ~ ~

- 4 - • S Medical Device Recalls: Examination of Selected Cases GAO/PEMD-90-6 October 6, 1990 FDA Drug Review: Postapproval Risks 1976-1985 GAO/PEMD-90-15 April 26, 1990 Medical Devices: Underreporting of Serious Problems With a Home Apnea Monitor GAO/PEMD-90-17 May 31, 1990 Food Tampering: FDA's Actions on Chilean Fruit Based on Sound Evidence GAO/HRD-90-164 September 6, 1990 Biotechnology: Processing Delays Continue for Growing Backlog of Patient Applications GAO/RCED-90-231 September 28, 1990 Food Safety and Quality: FDA Surveys Not Adequate to Demonstrate Safety of Milk Supply GAO/RCED-91-26 November 1, 1991 Food Safety and Quality: Who Does What in the Federal Government GAO/RCED-91-19A December 21, 1991 Food Safety and Quality: Who Does What in the Federal Government GAO/RCED-91-19B December 21, 1991 Food Safety and Quality: Stronger FDA Standards and Oversight Needed for ~ Bottled Water Q GAO/RCED-91-67 ~ March 21, 1991 ~ ~ ~ ~ ~

5 • • Food Safety and Quality: Existing Detection and Control Programs Minimize Alatoxin GAO/RCED-91-109 May 22, 1991 Pesticides: Food Consumption Data or Little Value to Estimate Some Exposures GAO/RCED-91-125 May 22, 1991 Financial Audit: Food and Nutrition Service's Financial Statements for Fiscal Years 1988 and 1987 GAO/AFMD-91-3 December 21, 1991 Food Tampering: Legal Authority Adequate to Deal With Threats GAO/HRD-91-20 October 31, 1991 Needed to Improve Timely Issuance. HRD-92-85, Apr. 7, 1992 (10 pages). FDA Premarket Approval: Process of Ansaid as a Drug. HRD-92-2, October 11, 1991 (15 pages). Freedom of Information: FDA's Program and Regulations Need Improvement. HRD-92-35, Feb. 211, 1992 (23 pages). FDA Regulations: Sustained Management Attention HRD-92-86, April 7, 1992 (9 pages). FDA Premarket Approval: Process of Olestra as a Food Additive. Approving Approving IMTEC-92-11, January 31, 1992 (27 pages). Food Safety: USDA Data Program Not Supporting Critical Pesticide Decisions. PEMD-92-9, January 10, 1992 (12 pages). Nonprescription Drugs: Over the Counter and Underemphasized. ~ O PEMD-92-10, February 13, 1992 (99 pages). Medical Technology: Quality Assurance Needs p~ Stronger Management Emphasis and Higher Priority. GD ~ C7 CO ~

6 • PEMD-92-20, September 23, 1992 (48 pages). Medical Technology: For Some Cardiac Pacemaker Leads, the Public Health Risks Are Still High. PEMD-92-26, August 6, 1992 (60 pages). Recombinant Bovine Growth Hormone: FDA Approval Should Be Withheld Until the Mastitis Issue Is Resolved. RCED-92-63, January 17, 1992 (17 pages). Food Safety and Quality: FDA Needs Stronger Controls Over the Approval Process for New Animal Drugs. RCED-92-69, April 21, 1992 (45 pages). Food Safety and Quality: Salmonella Control Efforts Show Need for More Coordination. RCED-92-152, June 26, 1992 (69 pages). Food Safety and Quality: Uniform, Risk-based Inspection System Needed to Ensure Safe Food Supply. RCED-92-205, September 24, 1992 (30 pages). Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery Shelves. RCED-92-209, August 5, 1992 (63 pages). Food Safety and Quality: FDA Strategy Needed to Address Animal Drug Residues in Milk. RCED-92-120, July 6 1992 (10 pages). Food Safety and Quality: FDA Can Improve Monitoring of Imported Cheese. FDA Premarket Approval: Process of Approving Lodine as a Drug GAO/HRD-93-81, April 12, 1993 (14 pages). Hospital Sterilants: Insufficient FDA Regulation May Pose a Public Health Risk GAO/HRD-93-79, June 14, 1993 (38 pages). O ~ ~ C,p ~ .-a

7 • • Food Safety and Quality: Innovative Strategies May Be Needed to Regulate New Food Technologies GAO/RCED-93-142, July 26, 1993 (101 pages). Pesticides: Limited Testing Finds Few Exported Unregistered -Pesticide Violations on Imported Food GAO/RCED-94-1, October 6, 1993 (34 pages). Pesticides: Options to Achieve a Single Regulatory Standard GAO/RCED-94-57, May 13, 1994 (34 pages). FDA Regulation: Compliance by Dietary Supplement and Conventional Food Establishments GAO/HEHS-94-134, June 13, 1994 (16 pages). ~ ~ ~ C.C) Ot~