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GAO Reports by subject "Drug approvals"

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Date Report No. Title
Date Sept. 14, 2011 Report No. GAO-11-936T Title

Drug Safety: FDA Faces Challenges Overseeing the Foreign Drug Manufacturing Supply Chain

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

Pediatric Research: Products Studied under Two Related Laws, but Improved Tracking Needed by FDA

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

New Drug Approval: FDA's Consideration of Evidence from Certain Clinical Trials

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

New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints

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

Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation

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

Food and Drug Administration: Approval and Oversight of the Drug Mifeprex

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

Prescription Drugs: Many Factors Affected FDA's Approval of Selected 'Pipeline' Drugs

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

European Union Drug Approval: Overview of New European Medicines Evaluation Agency and Approval Process

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

FDA Drug Approval: Review Time Has Decreased in Recent Years

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

FDA Premarket Approval: Process of Approving Lodine as a Drug

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

FDA Premarket Approval: Process of Approving Ansaid as a Drug

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

Food Safety and Quality: FDA Needs Stronger Controls Over the Approval Process for New Animal Drugs

.- .._ __.... .__. ._ .._._.... - .,......._. . -._ .- 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

FDA's Reviews of New Drugs: Changes Needed in Process for Reviewing and Reporting on Clinical Studies

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

Government Operations: Progress and Problems in FDA's Drug Approval Process

. * 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

Speeding Up the Drug Review Process: Results Encouraging but Progress Slow

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

Health: Efforts To Speed Up the Drug Review Process

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

Business, Industry, and Consumers: FDA Drug Approval--A Lengthy Process That Delays the Availability of Important New Drugs

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

Health: Food and Drug Administration's Drug Approval Process

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 ...