| Date |
Report No. |
Title |
| Date Sept. 14, 2011 |
Report No. GAO-11-936T |
Title
United States Government Accountability Office GAO
For Release on Delivery Expected at 10:00 a.m. EDT Wednesday, September 14, 2011 Testimony Before the Committee on Health, Education, Labor, and Pensions, U.S. Senate DRUG SAFETY FDA Faces Challenges Overseeing the Foreign Drug Manufacturing Supply Chain
Statement of Marcia Crosse Director, Health Care GAO-11-936T September 14, 2011 DRUG SAFETY
FD... |
| Date May 31, 2011 |
Report No. GAO-11-457 |
Title
United States Government Accountability Office GAO
May 2011 Report to Congressional Committees PEDIATRIC RESEARCH Products Studied under Two Related Laws, but Improved Tracking Needed by FDA GAO-11-457 May 2011 PEDIATRIC RESEARCH
Accountability • Integrity • Reliability Products Studied under Two Related Laws, but Improved Tracking Needed by FDA
Highlights of GAO-11-457, a report to congressio... |
| Date July 30, 2010 |
Report No. GAO-10-798 |
Title
United States Government Accountability Office GAO
July 2010 Report to Congressional Requesters NEW DRUG APPROVAL FDA’s Consideration of Evidence from Certain Clinical Trials GAO-10-798 July 2010 NEW DRUG APPROVAL Highlights
Highlights of GAO-10-798, a report to congressional requesters Accountability Integrity Reliability FDA’s Consideration of Evidence from Certain Clinical Trials Why GAO Di... |
| Date Sept. 23, 2009 |
Report No. GAO-09-866 |
Title
United States Government Accountability Office GAO
September 2009 Report to the Ranking Member, Committee on Finance, U.S. Senate NEW DRUG APPROVAL FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints GAO-09-866 September 2009 NEW DRUG APPROVAL Highlights
Highlights of GAO-09-866, a report to the Ranking Member, Committee on Finance, U.S. Senate Accountability I... |
| Date March 26, 2009 |
Report No. GAO-09-448T |
Title
United States Government Accountability Office GAO
For Release on Delivery Expected at 10:00 a.m. EDT Thursday, March 26, 2009 Testimony Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives HUMAN SUBJECTS RESEARCH Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation
Statement of Gregory D.... |
| Date Aug. 7, 2008 |
Report No. GAO-08-751 |
Title
United States Government Accountability Office GAO
August 2008 Report to Congressional Requesters FOOD AND DRUG ADMINISTRATION Approval and Oversight of the Drug Mifeprex GAO-08-751 August 2008 FOOD AND DRUG ADMINISTRATION Highlights
Highlights of GAO-08-751, a report to congressional requesters Accountability Integrity Reliability Approval and Oversight of the Drug Mifeprex Why GAO Did This Study... |
| Date Aug. 10, 2000 |
Report No. HEHS-00-140 |
Title
United States General Accounting Office GAO
August 2000 Report to Congressional Requesters PRESCRIPTION DRUGS Many Factors Affected FDA’s Approval of Selected “Pipeline” Drugs GAO/HEHS-00-140 Contents Letter Appendixes
Appendix I: Scope and Methodology 3 26 29 32 45 49 Appendix II: Approval Time Comparisons Appendix III: Approval Process for Claritin Appendix IV: Approval Process for Relafen... |
| Date April 5, 1996 |
Report No. HEHS-96-71 |
Title
United States General Accounting Office GAO
April 1996 Report to the Chairman, Committee on Labor and Human Resources, U.S. Senate EUROPEAN UNION DRUG APPROVAL Overview of New European Medicines Evaluation Agency and Approval Process G A O years
1921 - 1996 GAO/HEHS-96-71 GAO United States General Accounting Office Washington, D.C. 20548 Health, Education, and Human Services Division B-261605 Apri... |
| Date Oct. 20, 1995 |
Report No. PEMD-96-1 |
Title
United States General Accounting Office GAO
October 1995 Report to Congressional Requesters FDA DRUG APPROVAL Review Time Has Decreased in Recent Years GAO/PEMD-96-1 GAO United States General Accounting Office Washington, D.C. 20548 Program Evaluation and Methodology Division B-266023 October 20, 1995 The Honorable Nancy Landon Kassebaum Chairman The Honorable Edward M. Kennedy Ranking Minority Me... |
| Date April 12, 1993 |
Report No. HRD-93-81 |
Title
IJnited States General Accounting Office Report to Congressional Requesters FDA PREMARKET APPROVAL Process of Approving Lodine as a Drug GAO United States General Accounting Of’ flce Washington, D.C. 20548 Human Resource6 Division B-262669 April 12,1903 The Honorable William J. Hughes Chairman, Subcommittee on Intellectual Property and Judicial Administration Committee on the Judiciary House of ... |
| Date April 7, 1992 |
Report No. HRD-92-85 |
Title
GAO United States General Accounting OflIce Washington, D.C. 20648 Human Resources Division B-248171 April 7,1992 The Honorable William J. Hughes Chairman, Subcommittee on Intellectual Property and Judicial Administration Committee on the Judiciary House of Representatives The Honorable Dennis DeConcini Chairman, Subcommittee on Patents, Copyrights, and Trademarks Committee on the Judiciary Unite... |
| Date Jan. 17, 1992 |
Report No. RCED-92-63 |
Title
.- .._ __.... .__. ._ .._._.... - .,......._. . -._ .- t,44 .-.-I.--.-.-.-~-----~.~ Of’f’iw ^... -........... Sl.;tIJvs (;c~~rc~r;rl Acwbunling --.___ ~I. tIlli..“l-._-.-l-“l.-- -.“-.- --_.-I_-- FOOD SAFETY AND QUALITY FDA Needs Stronger Controls Over the Approval Process for New Animal Drugs GAO unitedstatee General Accounting Offlce
Washington, D.C. 20648 Resources, Community, and Econ... |
| Date Sept. 12, 1988 |
Report No. HRD-88-100 |
Title
United States General Accounting Office GAO
September 1988 Report to the Ranking Minority Member, .’ Special Committee on Aging, U.S. Senate FDA’S REVIEWS OF NEW DRUGS ChangesNeeded in Processfor Reviewing and Reporting on Clinical Studies BESTRImbNot tobedeased outside the General Accounting Of&a excapt on the basis of the specific approval by the Office of Congreriorrsl Relatia GAWHRD-88-100... |
| Date Dec. 15, 1981 |
Report No. 116887 |
Title
. * t ' Address Presented to
25th. Annual Educational Conference
bY The Food and Drug Law I n s t i t u t e in Washington, D.C. on December 15-1 6 , 1981 Murray Grant, M.D., D.P.H. "PROGRESS AND PROBLEMS IN FDA'S DRUG APPROVAL PROCESS" PROGRESS AND PROBLEMS IN FDA'S DRUG APPROVAL PROCESS In My of l a s t year the GAO issued a report on the FDA's drug approval a process that followed almost 3 years... |
| Date Nov. 23, 1981 |
Report No. HRD-82-16 |
Title
Comptroller General
CiF THE UNITEDSTATES Speeding Up The Drug Review Ffrocess:Results Encouraging -E&t Progress Slow G ’0 is recommending actions that the Secreta of Health and Human Services could take to 4Yurther reduce drug review time. 117126 tj RD.8246 NOVEMBEdr 23,1981 Raquast for copies of GAO reports should be sent to: U.S. General Accounting Office Document Handling and Information Serv... |
| Date Sept. 16, 1981 |
Report No. 116350 |
Title
UNITED STATES GENERAL ACCOUNTING OFFICE WASHINGTON, D.C. 20548 FOR RELEASE ON DELIVERY Expected at 10:00 A.M. EDT September 16, 1981 STATEMENT OF EDWARD A. DENSMORE, DEPUTY DIRECTOR, HUMAN RESOURCES DIVISION BEFORE THE SUBCOMMITTEE ON NATURAL RESOURCES, AGRICULTURE RESEARCH AND ENVIRONMENT, HOUSE COMMITTEE ON SCIENCE AND TECHNOLOGY ON THE FOOD AND DRUG ADMINISTRATION'S EFFORTS TO SPEED UP THE DRUG... |
| Date May 28, 1980 |
Report No. HRD-80-64 |
Title
BY THECOMPTROLLERGENERAL Report To The Subcommittee On Science, a Research, And Technology, House Committee On Science And Technology
OF THEUNITEDSTATES FDA Drug Approval--A Lengthy Process That Delays The Availability Of Important New Drugs
The average time required by the Food and Drug Administration to approve drugs--some of which could provide increased therapeutic benefits--is 20 months, incl... |
| Date June 19, 1979 |
Report No. 109679 |
Title
DNITEL STATES GENERAL ACCOUNTING I3.C. 20546 OFFICE WASHINGTON, FOR RELEASE GPj DELIVERY EXFECTEC AT lG:OO A.M. EDT JUNE 19, 1'379 GREGORY J. STATEMENT OF GIRECTOR, HUMAN RESOURCES CIVISION BEFORE THE COMMITTEE ON SCIENCE ANG TECHNOLOGY SUECOMMITTEE ON SCIENCE, RESEARCH ANC TECHNOLOGY OPi THE: FOOLj ANL; I;RUG ADMINISTRATION'S CRUG APFROVAL, YROCkSS AHART, J 109679 Mr.
Fleased our review Chairmen ... |
