메뉴 건너뛰기




Volumn , Issue , 2007, Pages 1-332

The future of drug safety: Promoting and protecting the health of the public

Author keywords

[No Author keywords available]

Indexed keywords


EID: 84988666676     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.17226/11750     Document Type: Book
Times cited : (216)

References (286)
  • 1
    • 85080796397 scopus 로고    scopus 로고
    • NEWS-IOM Panel Urged to Immediately Recommend that Congress Toughen Drug Safety Laws to Save Lives: Consumers Union Testifies Today That Obvious Safety Problems Need Action Now
    • [Online], [accessed June 9, 2005].
    • Consumers Union. 2005. NEWS-IOM Panel Urged to Immediately Recommend that Congress Toughen Drug Safety Laws to Save Lives: Consumers Union Testifies Today That Obvious Safety Problems Need Action Now. [Online]. Available: http://www.pharmalive. com/news/print.cfm?articleid=247043 [accessed June 9, 2005].
    • (2005)
  • 3
    • 84872430770 scopus 로고    scopus 로고
    • The Public Has Doubts About the Pharmaceutical Industry's Willingness to Publish Safety Information About Their Drugs in a Timely Manner
    • [Online], [accessed March 10, 2006].
    • Harris Interactive. 2005. The Public Has Doubts About the Pharmaceutical Industry's Willingness to Publish Safety Information About Their Drugs in a Timely Manner. [Online]. Available: http://www.harrisinteractive.com/news/printerfriend/index.asp?NewsID=882 [accessed March 10, 2006].
    • (2005)
  • 4
    • 85080662311 scopus 로고    scopus 로고
    • Comments of the National Consumers League to DKT. No. 2005N-0394
    • [Online], [accessed September 16, 2006].
    • NCL (National Consumers League). 2005. Comments of the National Consumers League to DKT. No. 2005N-0394 , Communication of Drug Safety Information. [Online]. Available: http://www.nclnet.org/advocacy/health/letter_drugsafety_01062006.htm [accessed September 16, 2006].
    • (2005) Communication of Drug Safety Information
  • 5
    • 58449105003 scopus 로고    scopus 로고
    • [Online]. [accessed February 20, 2006].
    • PricewaterhouseCoopers' Health Research Institute. 2005. Recapturing the Vision: Integrity Driven Performance in the Pharmaceutical Industry. [Online]. Available: http://www. pwc.com/extweb/pwcpublications.nsf/docid/EE74BACB6DE454768525702A00630CFF [accessed February 20, 2006].
    • (2005) Recapturing the Vision: Integrity Driven Performance in the Pharmaceutical Industry
  • 6
    • 84988552615 scopus 로고    scopus 로고
    • [Online], [accessed September 16, 2006].
    • US PIRG (United States Public Interest Research Group). 2006. Drug Safety. [Online]. Available: http://uspirg.org/uspirg.asp?id2=17568&id3=US& [accessed September 16, 2006].
    • (2006) Drug Safety
  • 7
    • 85080756926 scopus 로고    scopus 로고
    • The Drug Approval Pendulum
    • (The Washington Post) [Online], [accessed April 21, 2005].
    • Applebaum A (The Washington Post). 2005. The Drug Approval Pendulum. [Online]. Available: http://www.washingtonpost.com/wp-dyn/articles/A48135-2005Apr12.html [accessed April 21, 2005].
    • (2005)
    • Applebaum, A.1
  • 8
    • 0008005109 scopus 로고    scopus 로고
    • Guideline for the Format and Content of the Clinical and Statistical Sections of an Application
    • Rockville, MD: CDER.
    • CDER (Center for Drug Evaluation and Research). 1998. Guideline for the Format and Content of the Clinical and Statistical Sections of an Application. Rockville, MD: CDER.
    • (1998)
  • 9
    • 4243178130 scopus 로고    scopus 로고
    • The changing structure of the pharmaceutical industry
    • Cockburn IM. 2004. The changing structure of the pharmaceutical industry. Health Aff (Millwood) 23(1):10-22.
    • (2004) Health Aff (Millwood) , vol.23 , Issue.1 , pp. 10-22
    • Cockburn, I.M.1
  • 11
    • 0003444414 scopus 로고    scopus 로고
    • [Online], [accessed October 10, 2005].
    • DHHS (Department of Health and Human Services), FDA, Task Force on Risk Management. 1999. Managing the Risks from Medical Product Use: Creating a Risk Management Framework. [Online]. Available: http://www.fda.gov/oc/tfrm/riskmanagement.pdf [accessed October 10, 2005].
    • (1999) Managing the Risks from Medical Product Use: Creating a Risk Management Framework
  • 13
    • 85080690929 scopus 로고    scopus 로고
    • Establishment of Prescription Drug User Fee rates for fiscal year 2006
    • FDA. 2005a. Establishment of Prescription Drug User Fee rates for fiscal year 2006. Fed Reg 70(146):44106-44109.
    • (2005) Fed Reg , vol.70 , Issue.146 , pp. 44106-44109
  • 15
    • 0033549087 scopus 로고    scopus 로고
    • The safety of newly approved medicines: do recent market removals mean there is a problem?
    • Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ. 1999. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 281(18):1728-1734.
    • (1999) JAMA , vol.281 , Issue.18 , pp. 1728-1734
    • Friedman, M.A.1    Woodcock, J.2    Lumpkin, M.M.3    Shuren, J.E.4    Hass, A.E.5    Thompson, L.J.6
  • 16
    • 85080642334 scopus 로고    scopus 로고
    • Drug safety: new legal/regulatory approaches
    • July/August
    • Ganslaw LS. Drug safety: new legal/regulatory approaches. FDLI July/August (4):7-10.
    • FDLI , Issue.4 , pp. 7-10
    • Ganslaw, L.S.1
  • 17
    • 85080682370 scopus 로고    scopus 로고
    • Doctors Fear Acne Drug Rules Go Too Far
    • (The New York Times). [Online], [accessed January 13, 2006].
    • Geraghty LN (The New York Times). 2006. Doctors Fear Acne Drug Rules Go Too Far. [Online]. Available: http://www.nytimes.com/2006/01/12/fashion/thursdaystyles/12skin. html [accessed January 13, 2006].
    • (2006)
    • Geraghty, L.N.1
  • 18
    • 85080664494 scopus 로고    scopus 로고
    • Technologies in drug discovery/drug development: the next generation
    • Aug
    • Gwynne P, Heebner G. 2001. Technologies in drug discovery/drug development: the next generation. Science Aug:1-17.
    • (2001) Science , pp. 1-17
    • Gwynne, P.1    Heebner, G.2
  • 19
    • 84990352958 scopus 로고    scopus 로고
    • Drug approvals: safe at any speed?
    • Hart C. 1999. Drug approvals: safe at any speed? Mod Drug Disc 2(5):25-26, 28.
    • (1999) Mod Drug Disc , vol.2 , Issue.5 , pp. 25-28
    • Hart, C.1
  • 20
    • 85080773959 scopus 로고    scopus 로고
    • Five Ways to Fix the FDA
    • [Online], [accessed July 1, 2005].
    • Herper M. 2005. Five Ways to Fix the FDA. [Online]. Available: http://www.forbes.com/healthcare/ 2005/01/12/cx_mh_0112fdaintro.html [accessed July 1, 2005].
    • (2005)
    • Herper, M.1
  • 22
    • 85080721270 scopus 로고    scopus 로고
    • Kaiser HealthPoll Report Views on Prescription Drugs and the Pharmaceutical Industry
    • [Online], [accessed September 22, 2005].
    • Kaiser Family Foundation. 2005. Kaiser HealthPoll Report Views on Prescription Drugs and the Pharmaceutical Industry. [Online]. Available: http://www.kff.org/healthpollreport/ feb_2005/upload/full_report.pdf [accessed September 22, 2005].
    • (2005)
  • 23
    • 85007729496 scopus 로고    scopus 로고
    • Is the FDA approving drugs too fast? Probably not-but drug recalls have sparked debate
    • [see comment].
    • Kleinke JD, Gottlieb S. 1998. Is the FDA approving drugs too fast? Probably not-but drug recalls have sparked debate. [see comment]. BMJ 317(7163):899.
    • (1998) BMJ , vol.317 , Issue.7163 , pp. 899
    • Kleinke, J.D.1    Gottlieb, S.2
  • 24
    • 0033519032 scopus 로고    scopus 로고
    • FDA approves drugs even when experts on its advisory panels raise safety questions
    • Landow L. 1999. FDA approves drugs even when experts on its advisory panels raise safety questions. BMJ 318(7188):944.
    • (1999) BMJ , vol.318 , Issue.7188 , pp. 944
    • Landow, L.1
  • 25
    • 3042781214 scopus 로고    scopus 로고
    • FDA Medical Officers Report Lowers Standards Permit Dangerous Drug Approvals
    • [Online]. [accessed October 15, 2005].
    • Lurie P, Wolfe SM. 1998. FDA Medical Officers Report Lowers Standards Permit Dangerous Drug Approvals. [Online]. Available: http://www.citizen.org/publications/release. cfm?ID=7104 [accessed October 15, 2005].
    • (1998)
    • Lurie, P.1    Wolfe, S.M.2
  • 26
    • 0033596257 scopus 로고    scopus 로고
    • Safety of FDA-approved drugs
    • Lurie P, Sasich LD. 1999. Safety of FDA-approved drugs. JAMA 282(24):2297-2298.
    • (1999) JAMA , vol.282 , Issue.24 , pp. 2297-2298
    • Lurie, P.1    Sasich, L.D.2
  • 27
    • 27744556191 scopus 로고    scopus 로고
    • Why America needs a strong FDA
    • Markel H. 2005. Why America needs a strong FDA. JAMA 294(19):2489-2491.
    • (2005) JAMA , vol.294 , Issue.19 , pp. 2489-2491
    • Markel, H.1
  • 28
    • 25144518364 scopus 로고    scopus 로고
    • Financial anatomy of biomedical research
    • Moses H, Dorsey ER, Matheson DHM, Their SO. 2005. Financial anatomy of biomedical research. JAMA 294(11):1333-1342.
    • (2005) JAMA , vol.294 , Issue.11 , pp. 1333-1342
    • Moses, H.1    Dorsey, E.R.2    Matheson, D.H.M.3    Their, S.O.4
  • 29
    • 58449105003 scopus 로고    scopus 로고
    • Recapturing the Vision:Integrity Driven Performance in the Pharmaceutical Industry
    • [Online]. [accessed March 10, 2006].
    • PricewaterhouseCoopers' Health Research Institute. 2005. Recapturing the Vision:Integrity Driven Performance in the Pharmaceutical Industry. [Online]. Available: http://www. pwc.com/extweb/pwcpublications.nsf/docid/EE74BACB6DE454768525702A00630CFF [accessed March 10, 2006].
    • (2005)
  • 30
    • 1842570786 scopus 로고    scopus 로고
    • Pharmacoepidemiology
    • In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM., New York: McGraw-Hill Medical.
    • Stergachis A, Hazlet T. 2002. Pharmacoepidemiology. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: A Pathophysiologic Approach. New York: McGraw-Hill Medical. Pp. 91-97.
    • (2002) Pharmacotherapy: A Pathophysiologic Approach , pp. 91-97
    • Stergachis, A.1    Hazlet, T.2
  • 31
    • 20444507230 scopus 로고    scopus 로고
    • History of the FDA
    • [Online]. [accessed January 14, 2006].
    • Swann JP. 1998. History of the FDA. [Online]. Available: http://www.fda.gov/oc/history/ historyoffda/fulltext.html [accessed January 14, 2006].
    • (1998)
    • Swann, J.P.1
  • 32
    • 0038239880 scopus 로고    scopus 로고
    • Important drug safety information on the internet: assessing its accuracy and reliability
    • Tatsioni A, Gerasi E, Charitidou E, Simou N, Mavreas V, Ioannidis JP. 2003. Important drug safety information on the internet: assessing its accuracy and reliability. Drug Saf 26(7):519-527.
    • (2003) Drug Saf , vol.26 , Issue.7 , pp. 519-527
    • Tatsioni, A.1    Gerasi, E.2    Charitidou, E.3    Simou, N.4    Mavreas, V.5    Ioannidis, J.P.6
  • 33
    • 85080749142 scopus 로고    scopus 로고
    • Reauthorization of the Prescription Drug User Fee Act
    • [Online]. [accessed September 14.2006].
    • Tauzin B. 2002. Reauthorization of the Prescription Drug User Fee Act. Statement at the March 6, 2002 Hearing of the Committee on Energy and Commerce. [Online]. Available: http:// energycommerce.house.gov/107/action/107-93.pdf [accessed September 14, 2006].
    • (2002) Statement at the March 6, 2002 Hearing of the Committee on Energy and Commerce
    • Tauzin, B.1
  • 34
    • 85080710674 scopus 로고    scopus 로고
    • Rushing Through?
    • [Online], [accessed July 1, 2005].
    • Tone B. 1999. Rushing Through? Questioning the Safety of Drug Approvals. [Online]. Available: http://www.nurseweek.com/features/99-11/fda.html [accessed July 1, 2005].
    • (1999) Questioning the Safety of Drug Approvals
    • Tone, B.1
  • 35
    • 84946744872 scopus 로고    scopus 로고
    • [Online]. [accessed August 26. 2006].
    • US House of Representatives Committee on Government Reform Minority Staff. 2006. Prescription for Harm: The Decline in FDA Enforcement Activity. [Online]. Available: http://www.democrats.reform.house.gov/Documents/20060627101434-98349.pdf [accessed August 26, 2006].
    • (2006) Prescription for Harm: The Decline in F.D.A Enforcement Activity
  • 36
    • 84872430770 scopus 로고    scopus 로고
    • The Public Has Doubts About the Pharmaceutical Industry's Willingness to Publish Safety Information About Their Drugs in a Timely Manner
    • [Online]. [accessed March 10, 2006].
    • Wall Street Journal, Harris Interactive. 2005. The Public Has Doubts About the Pharmaceutical Industry's Willingness to Publish Safety Information About Their Drugs in a Timely Manner. [Online]. Available: http://www.harrisinteractive.com/news/printerfriend/index. asp?NewsID=882 [accessed March 10, 2006].
    • (2005)
  • 37
    • 0032542251 scopus 로고    scopus 로고
    • Making medicines safer-the need for an independent drug safety board
    • Wood AJ, Stein CM, Woosley R. 1998. Making medicines safer-the need for an independent drug safety board. N Engl J Med 339(25):1851-1854.
    • (1998) N Engl J Med , vol.339 , Issue.25 , pp. 1851-1854
    • Wood, A.J.1    Stein, C.M.2    Woosley, R.3
  • 38
    • 23444458067 scopus 로고    scopus 로고
    • The Prescription Drug User Fee Act: is a faster Food and Drug Administration always a better Food and Drug Administration?
    • Zelenay JL. 2005. The Prescription Drug User Fee Act: is a faster Food and Drug Administration always a better Food and Drug Administration? Food and Drug Law J 60(2):261-338.
    • (2005) Food and Drug Law J , vol.60 , Issue.2 , pp. 261-338
    • Zelenay, J.L.1
  • 40
    • 33645675960 scopus 로고    scopus 로고
    • Estimating the cost of new drug development: is it really $ 802 million?
    • Adams CP, Brantner VV. 2006. Estimating the cost of new drug development: is it really $802 million? Health Aff 25(2):420-428.
    • (2006) Health Aff , vol.25 , Issue.2 , pp. 420-428
    • Adams, C.P.1    Brantner, V.V.2
  • 41
    • 85080791714 scopus 로고    scopus 로고
    • Drug Safety Reshaping FDA Monolith
    • [Online]. [accessed September 15, 2006].
    • Agres T. 2006. Drug Safety Reshaping FDA Monolith. [Online]. Available: http://www.dddmag. com/ShowPR.aspx?PUBCODE=016&ACCT=1600000100&ISSUE=0504&RELTY PE=PR&ORIGRELTYPE=PNP&PRODCODE=00000000&PRODLETT=AF [accessed September 15, 2006].
    • (2006)
    • Agres, T.1
  • 42
    • 84889452671 scopus 로고    scopus 로고
    • spontaneous reporting in the United States
    • Chapter 9: In: Strom BS, Ed., Fourth ed. West Sussex, England: John Wiley & Sons.
    • Ahmad SR, Goetsch RA, Marks NS. 2005. Chapter 9: spontaneous reporting in the United States. In: Strom BS, Ed. Pharmacoepidemiology. Fourth ed. West Sussex, England: John Wiley & Sons. Pp. 135-159.
    • (2005) Pharmacoepidemiology , pp. 135-159
    • Ahmad, S.R.1    Goetsch, R.A.2    Marks, N.S.3
  • 43
    • 0037132675 scopus 로고    scopus 로고
    • The verdict from ALLHAT-thiazide diuretics are the preferred initial therapy for hypertension
    • Appel JL. 2002. The verdict from ALLHAT-thiazide diuretics are the preferred initial therapy for hypertension. JAMA 288(23):3030-3042.
    • (2002) JAMA , vol.288 , Issue.23 , pp. 3030-3042
    • Appel, J.L.1
  • 44
    • 0031923812 scopus 로고    scopus 로고
    • FDA, off-label use, and informed consent: debunking myths and misconceptions
    • Beck JM, Azari ED. 1998. FDA, off-label use, and informed consent: debunking myths and misconceptions. Food Drug Law J 53(1):71-104.
    • (1998) Food Drug Law J , vol.53 , Issue.1 , pp. 71-104
    • Beck, J.M.1    Azari, E.D.2
  • 45
    • 85080764930 scopus 로고    scopus 로고
    • Letter to Knoll Pharmaceutical Company
    • Rockville, MD
    • Bilstad J (HHS, FDA, CDER, Office of Drug Evaluation II). 1997. Letter to Knoll Pharmaceutical Company. Rockville, MD.
    • (1997)
    • Bilstad, J.1
  • 46
    • 85080747850 scopus 로고    scopus 로고
    • Many Drug Uses Don't Rest on Strong Science
    • [Online], [accessed July 3, 2006].
    • Boodman SG. 2006. Many Drug Uses Don't Rest on Strong Science. [Online]. Available: http:// www.washingtonpost.com/wp-dyn/content/article/2006/05/22/AR2006052201428.html? referrer=emailarticle [accessed July 3, 2006].
    • (2006)
    • Boodman, S.G.1
  • 47
    • 12244301636 scopus 로고    scopus 로고
    • Direct-to-consumer drug advertisements on network television: an exploration of quantity, frequency, and placement
    • Brownfield ED, Bernhardt JM, Phan JL, Williams MV, Parker RM. 2004. Direct-to-consumer drug advertisements on network television: an exploration of quantity, frequency, and placement. J Health Commun 9(6):561-562.
    • (2004) J Health Commun , vol.9 , Issue.6 , pp. 561-562
    • Brownfield, E.D.1    Bernhardt, J.M.2    Phan, J.L.3    Williams, M.V.4    Parker, R.M.5
  • 48
    • 0033515256 scopus 로고    scopus 로고
    • Ten great public health achievements- United States 1900-1999
    • CDC (Centers for Disease Control and Prevention). 1999. Ten great public health achievements- United States 1900-1999. MMWR 48(12):241-243.
    • (1999) MMWR , vol.48 , Issue.12 , pp. 241-243
  • 49
    • 85080672210 scopus 로고    scopus 로고
    • Clinical Review Template, MAPP 6010.3.
    • [Online], [accessed May 19, 2006].
    • CDER (Center for Drug Evaluation and Research). 2004. Clinical Review Template, MAPP 6010.3. [Online]. Available: http://www.fda.gov/cder/mapp/6010.3.pdf [accessed May 19, 2006].
    • (2004)
  • 50
    • 84884151607 scopus 로고    scopus 로고
    • [Online]. Available, accessed May 19, 2005
    • CDER. 2005a. Drug Safety and Risk Management Advisory Committee (DSaRM). [Online]. Available: http://www.fda.gov/OHRMS/DOCKETS/AC/05/agenda/2005-4143A1_Final. htm [accessed May 19, 2005].
    • (2005) Drug Safety and Risk Management Advisory Committee (DSaRM)
  • 52
    • 84988619616 scopus 로고    scopus 로고
    • [Online]. Available, accessed June 20, 2005
    • CDER. 2005c. Drug Safety Oversight Board (DSB), MAPP 4151 -3. [Online]. Available: http:// www.fda.gov/cder/mapp/4151-3.pdf [accessed June 20, 2005].
    • (2005) Drug Safety Oversight Board (DSB), MAPP 4151 -3
  • 53
    • 34247343738 scopus 로고    scopus 로고
    • Medication Guides
    • [Online], [accessed July 6, 2006].
    • CDER. 2006. Medication Guides. [Online]. Available: www.fda.gov/cder/offices/ods/medication_ guides.htm [accessed July 6, 2006].
    • (2006)
  • 54
    • 0003991455 scopus 로고    scopus 로고
    • [Online]. [accessed November 14, 2005].
    • CDER, FDA, DHHS. 1998. The CDER Handbook. [Online]. Available: http://www.fda.gov/ cder/handbook/handbook.pdf [accessed November 14, 2005].
    • (1998) The CDER Handbook
  • 57
    • 85080757172 scopus 로고    scopus 로고
    • Merck Fought Vioxx Warning
    • [Online], [accessed October 10, 2005].
    • Curran J. 2005. Merck Fought Vioxx Warning. [Online]. Available: http://www.philly.com/ mld/philly/business/12707648.htm [accessed October 10, 2005].
    • (2005)
    • Curran, J.1
  • 58
    • 85080657480 scopus 로고    scopus 로고
    • Securing the Benefits of Medical Innovation for Seniors: The Role of Prescription Drugs and Drug Coverage
    • [Online], [accessed October 10.2005].
    • DHHS (Department of Health and Human Services). 2002. Securing the Benefits of Medical Innovation for Seniors: The Role of Prescription Drugs and Drug Coverage. [Online]. Available: http://aspe.hhs.gov/health/reports/medicalinnovation/innovation.pdf [accessed October 10, 2005].
    • (2002)
  • 59
    • 33746551430 scopus 로고    scopus 로고
    • Critical Path Opportunities Report
    • [Online], [accessed June 2.2006].
    • DHHS, FDA (Food and Drug Administration). 2006. Critical Path Opportunities Report. [Online]. Available: http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_report.pdf [accessed June 2, 2006].
    • (2006)
  • 60
    • 33646151086 scopus 로고    scopus 로고
    • Development and Use of Risk Minimization Action Plans
    • [Online], [accessed April 14, 2006].
    • DHHS, FDA, CDER, CBER (Center for Biologics Research). 2005. Development and Use of Risk Minimization Action Plans. [Online]. Available: http://www.fda.gov/cder/guidance/ 6358fnl.htm [accessed April 14, 2006].
    • (2005)
  • 62
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: new estimates of drug development costs
    • DiMasi JA, Hansen RW, Grabowski HG. 2003. The price of innovation: new estimates of drug development costs. J Health Econ 22(2):151-185.
    • (2003) J Health Econ , vol.22 , Issue.2 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 63
    • 85080734600 scopus 로고    scopus 로고
    • Issue Brief: Does America Have a Prescription Drug Problem?
    • [Online], [accessed July 27, 2006].
    • Epstein RA. 2004. Issue Brief: Does America Have a Prescription Drug Problem?. The Perils of Ignoring the Economics of Pharmaceuticals. [Online]. Available: http://www.ipi.org/ipi/IPIPublications.nsf/PublicationLookupFullTextPDF/ E6214F2C0ADBC86C86256F260069D1E2/File/EpsteinDrugProblem.pdf [accessed July 27, 2006].
    • (2004) The Perils of Ignoring the Economics of Pharmaceuticals
    • Epstein, R.A.1
  • 64
    • 0012340058 scopus 로고
    • Clinical Therapeutics and the Recognition of Drug-Induced Disease
    • [Online], [accessed July 12, 2006].
    • FDA (Food and Drug Administration). 1994. Clinical Therapeutics and the Recognition of Drug-Induced Disease. [Online]. Available: http://www.fda.gov/medwaTCH/articles/dig/ recognit.htm [accessed July 12, 2006].
    • (1994)
  • 66
    • 41049103694 scopus 로고    scopus 로고
    • MedWatch Reporting by Consumers
    • [Online], [accessed May 24, 2005].
    • FDA. 2003. MedWatch Reporting by Consumers. [Online]. Available: http://www.fda.gov/ medwatch/report/consumer/consumer.htm [accessed May 24, 2005].
    • (2003)
  • 69
    • 77950267684 scopus 로고    scopus 로고
    • [Online]. Available, accessed May 24, 2005
    • FDA. 2004c. Adverse Event Reporting System (AERS). [Online]. Available: http://www.fda. gov/cder/aers/default.htm [accessed May 24, 2005].
    • (2004) Adverse Event Reporting System (AERS)
  • 74
    • 84988618164 scopus 로고    scopus 로고
    • [Online]. Available, accessed February 23, 2005
    • FDA. 2005e. FDA Fact Sheet: FDA Improvement in Drug Safety Monitoring. [Online]. Available: http://www.fda.gov/oc/factsheets/drugsafety.html [accessed February 23, 2005].
    • (2005) FDA Fact Sheet: FDA Improvement in Drug Safety Monitoring
  • 75
    • 34248400810 scopus 로고    scopus 로고
    • Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products
    • April 2005. Rockville, MD: FDA.
    • FDA. 2005f. Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products. April 2005. Rockville, MD: FDA.
    • (2005)
  • 77
    • 85080675396 scopus 로고    scopus 로고
    • [Online]. Available, accessed July 3, 2006
    • FDA. 2006a. FDA Advisory Committees. [Online]. Available: http://www.fda.gov/oc/advisory/ default.htm [accessed July 3, 2006].
    • (2006) FDA Advisory Committees
  • 80
    • 33646789183 scopus 로고    scopus 로고
    • Report on the performance of drug and biologics firms in conducting postmarketing commitment studies
    • FDA. 2006d. Report on the performance of drug and biologics firms in conducting postmarketing commitment studies. Federal Register 71(42):10978-10979.
    • (2006) Federal Register , vol.71 , Issue.42 , pp. 10978-10979
  • 82
    • 32744465985 scopus 로고    scopus 로고
    • [Online]. Available, accessed June 16, 2006
    • FDA, CDER. 2001b. FDA's Drug Review and Approval Time. [Online]. Available: http://www. fda.gov/cder/reports/reviewtimes/default.htm [accessed June 16, 2006].
    • (2001) FDA's Drug Review and Approval Time
  • 83
    • 85080662967 scopus 로고    scopus 로고
    • Office of Drug Safety Annual Report FY 2004
    • [Online], [accessed June 23, 2005].
    • FDA, CDER. 2005. Office of Drug Safety Annual Report FY 2004. [Online]. Available: http:// www.fda.gov/cder/offices/ods/annrep2004/ [accessed June 23, 2005].
    • (2005)
  • 84
    • 85080699247 scopus 로고    scopus 로고
    • [Online]. Available, accessed July 3, 2006
    • FDA, CDER. 2006a. Drugs@FDA Instructions. [Online]. Available: http://www.fda.gov/cder/ drugsatfda/instructionsPrint.htm [accessed July 3, 2006].
    • (2006) Drugs@FDA Instructions
  • 85
    • 85080677566 scopus 로고    scopus 로고
    • [Online]. Available, accessed June 29, 2006
    • FDA, CDER. 2006b. Investigational New Drug (IND) Application Process. [Online]. Available: http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm#preIND [accessed June 29, 2006].
    • (2006) Investigational New Drug (IND) Application Process
  • 86
    • 85080649328 scopus 로고    scopus 로고
    • Information About Pregnancy Registries
    • [Online]. [accessed July 3, 2006].
    • FDA, Office of Women's Health. 2006. Information About Pregnancy Registries. [Online]. Available: http://www.fda.gov/womens/registries/general.html [accessed July 3, 2006].
    • (2006)
  • 87
    • 14044267273 scopus 로고    scopus 로고
    • FDA Launches a Multi-Pronged Strategy to Strengthen Safeguards for Children Treated with Antidepressant Medications
    • (October 15). [Online], [accessed September 15. 2006].
    • FDA News. 2004 (October 15). FDA Launches a Multi-Pronged Strategy to Strengthen Safeguards for Children Treated with Antidepressant Medications. [Online]. Available: http:// www.fda.gov/bbs/topics/news/2004/NEW01124.html [accessed September 15, 2006].
    • (2004)
  • 91
    • 0033549087 scopus 로고    scopus 로고
    • The safety of newly approved medicines: do recent market removals mean there is a problem?
    • Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ. 1999. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 281(18):1728-1734.
    • (1999) JAMA , vol.281 , Issue.18 , pp. 1728-1734
    • Friedman, M.A.1    Woodcock, J.2    Lumpkin, M.M.3    Shuren, J.E.4    Hass, A.E.5    Thompson, L.J.6
  • 92
    • 1542437819 scopus 로고    scopus 로고
    • Examining the FDA's oversight of directto- consumer advertising
    • W3-120-123.
    • Gahart MT, Duhamel LM, Dievler A, Price R. 2003. Examining the FDA's oversight of directto- consumer advertising. Health Aff (Millwood) Suppl Web Exclusives:W3-120-123.
    • (2003) Health Aff (Millwood)
    • Gahart, M.T.1    Duhamel, L.M.2    Dievler, A.3    Price, R.4
  • 93
    • 0003392834 scopus 로고
    • GAO/PEMD-90-15. Washington, DC: GAO.
    • GAO (Government Accountability Office). 1990. FDA Drug Review: Postapproval Risks 1976 -85 . GAO/PEMD-90-15. Washington, DC: GAO.
    • (1990) FDA Drug Review: Postapproval Risks 1976 -85
  • 95
    • 4444342056 scopus 로고    scopus 로고
    • Rebuilding big pharma's business model
    • Gilber J, Henske P, Singh A. 2003. Rebuilding big pharma's business model. Bus Med Rep 21(10):1-10.
    • (2003) Bus Med Rep , vol.21 , Issue.10 , pp. 1-10
    • Gilber, J.1    Henske, P.2    Singh, A.3
  • 96
    • 22144439810 scopus 로고    scopus 로고
    • Heal the damage: prescription drug consumer advertisements and relative choice
    • Gilhooley M. 2005. Heal the damage: prescription drug consumer advertisements and relative choice. J Health Law 38(1):Winter.
    • (2005) J Health Law , vol.38 , Issue.1 WINTER
    • Gilhooley, M.1
  • 97
    • 85080768885 scopus 로고    scopus 로고
    • Testimony of David J. Graham, M.D., M.P.H., November 18, 2004, [Online], [accessed October 10, 2005].
    • Graham DJ. 2004. Testimony of David J. Graham, M.D., M.P.H., November 18 , 2004 Before the Committee on Finance. [Online]. Available: http://www.senate.gov/~finance/hearings/ testimony/2004test/111804dgtest.pdf [accessed October 10, 2005].
    • (2004) Before the Committee on Finance.
    • Graham, D.J.1
  • 98
    • 85039604907 scopus 로고    scopus 로고
    • FDA, Merck and Vioxx: Putting Patient Safety First?
    • Statements at the November 18, 2004 hearing before the United States Senate Committee on Finance, United States Senate.
    • Grassley C, Baucus M, Graham D, Singh G, Psaty B, Kweder S, Gilmartin R. 2004. FDA, Merck and Vioxx: Putting Patient Safety First? Statements at the November 18, 2004 hearing before the United States Senate Committee on Finance, United States Senate.
    • (2004)
    • Grassley, C.1    Baucus, M.2    Graham, D.3    Singh, G.4    Psaty, B.5    Kweder, S.6    Gilmartin, R.7
  • 99
    • 85080708961 scopus 로고    scopus 로고
    • Doc Room Stats for IOM
    • (February). Personal Communication: E-mail to Stratton K (I.O.M Staff).
    • Henderson D. 2006 (February). Doc Room Stats for IOM. Personal Communication: E-mail to Stratton K (IOM Staff).
    • (2006)
    • Henderson, D.1
  • 100
    • 85080760316 scopus 로고    scopus 로고
    • Vioxx Verdict Stokes Backlash That Hit FDA, Manufacturers
    • [Online]. [accessed October 10. 2005].
    • Hensley S, Davies P, Martinez B. 2005. Vioxx Verdict Stokes Backlash That Hit FDA, Manufacturers. [Online]. Available: http://online.wsj.com/article/0, SB112467370587619279- email,00.html [accessed October 10, 2005].
    • (2005)
    • Hensley, S.1    Davies, P.2    Martinez, B.3
  • 102
    • 33750328584 scopus 로고    scopus 로고
    • Washington, DC: The National Academies Press.
    • IOM (Institute of Medince). 2007. Preventing Medication Errors. Washington, DC: The National Academies Press.
    • (2007) Preventing Medication Errors
  • 103
    • 13744260702 scopus 로고    scopus 로고
    • [accessed March 10, 2006].
    • Kaiser Family Foundation. 2005. Prescription Drug Trends. [Online]. Available: http://www. kff.org/insurance/upload/3057-04.pdf [accessed March 10, 2006].
    • (2005) Prescription Drug Trends
  • 105
    • 1642369095 scopus 로고    scopus 로고
    • Pregnancy exposure registries
    • Kennedy DL, Uhl K, Kweder SL. 2004. Pregnancy exposure registries. Drug Saf 27(4): 215-228.
    • (2004) Drug Saf , vol.27 , Issue.4 , pp. 215-228
    • Kennedy, D.L.1    Uhl, K.2    Kweder, S.L.3
  • 107
    • 0035462130 scopus 로고    scopus 로고
    • From idea to market: the drug approval process
    • Lipsky MS, Sharp LK. 2001. From idea to market: the drug approval process. J Am Board Fam Pract 14(5):362-367.
    • (2001) J Am Board Fam Pract , vol.14 , Issue.5 , pp. 362-367
    • Lipsky, M.S.1    Sharp, L.K.2
  • 108
    • 84988543093 scopus 로고    scopus 로고
    • FDA drug review: the debate over safety, efficacy, and speed
    • Lurie P, Woodcock J, Kaitin KI. 1999. FDA drug review: the debate over safety, efficacy, and speed. Medical Crossfire 1(3):52-60.
    • (1999) Medical Crossfire , vol.1 , Issue.3 , pp. 52-60
    • Lurie, P.1    Woodcock, J.2    Kaitin, K.I.3
  • 109
    • 0036633623 scopus 로고    scopus 로고
    • The FDA's drug review process: ensuring drugs are safe and effective
    • Meadows M. 2002. The FDA's drug review process: ensuring drugs are safe and effective. FDA Consum 36(4):19-24.
    • (2002) FDA Consum , vol.36 , Issue.4 , pp. 19-24
    • Meadows, M.1
  • 110
    • 84881270225 scopus 로고    scopus 로고
    • [accessed July 12, 2006].
    • Meadows M. 2003. Drug Research and Children. [Online]. Available: http://www.fda.gov/ fdac/features/2003/103_drugs.html [accessed July 12, 2006].
    • (2003) Drug Research and Children
    • Meadows, M.1
  • 112
    • 19044371607 scopus 로고    scopus 로고
    • FDA fails to reduce accessibility of paracetamol despite 450 deaths a year
    • Moynihan R. 2002. FDA fails to reduce accessibility of paracetamol despite 450 deaths a year. BMJ 325(7366):678.
    • (2002) BMJ , vol.325 , Issue.7366 , pp. 678
    • Moynihan, R.1
  • 115
    • 85080706913 scopus 로고    scopus 로고
    • [accessed July 12, 2006].
    • NHLBI (National Heart, Lung and Blood Institute). 2005. Cardiac Arrhythmia Suppression Trial (CAST). [Online]. Available: http://www.clinicaltrials.gov/ct/show/NCT00000526 [accessed July 12, 2006].
    • (2005) Cardiac Arrhythmia Suppression Trial (CAST)
  • 116
    • 15444380375 scopus 로고    scopus 로고
    • Safety in numbers-monitoring risk in approved drugs
    • Okie S. 2005. Safety in numbers-monitoring risk in approved drugs. N Engl J Med 352(12): 1173-1176.
    • (2005) N Engl J Med , vol.352 , Issue.12 , pp. 1173-1176
    • Okie, S.1
  • 117
    • 33947232511 scopus 로고    scopus 로고
    • Washington, DC.
    • PhRMA (Pharmaceutical Research and Manufacturers of America). 2006. Pharmaceutical Industry Profile. Washington, DC.
    • (2006) Pharmaceutical Industry Profile
  • 120
    • 84938235907 scopus 로고    scopus 로고
    • [accessed June 27, 2005].
    • Randall, B. 2001. The US Drug Approval Process: A Primer. [Online]. Available: http://www. thememoryhole.org/crs/more-reports/RL30989.pdf [accessed June 27, 2005].
    • (2001) The US Drug Approval Process: A Primer
    • Randall, B.1
  • 121
    • 30444449389 scopus 로고    scopus 로고
    • Reform of drug regulation-beyond an independent drug-safety board
    • Ray WA, Stein CM. 2006. Reform of drug regulation-beyond an independent drug-safety board. N Engl J Med 354(2):194-201.
    • (2006) N Engl J Med , vol.354 , Issue.2 , pp. 194-201
    • Ray, W.A.1    Stein, C.M.2
  • 124
    • 12844253825 scopus 로고    scopus 로고
    • Health spending growth slows in 2003
    • Smith C, Cowan C, Sensenig A, Catlin A, the Health Accounts Team. 2005. Health spending growth slows in 2003. Health Aff 24(1):185-194.
    • (2005) Health Aff , vol.24 , Issue.1 , pp. 185-194
    • Smith, C.1    Cowan, C.2    Sensenig, A.3    Catlin, A.4
  • 126
    • 85080705332 scopus 로고    scopus 로고
    • [accessed March 8, 2005].
    • Wolfe S. 2004. Take Drugs Off the Market. [Online]. Available: http://www.usatoday.com/ news/opinion/editorials/2004-12-26-oppose_x.htm [accessed March 8, 2005].
    • (2004) Take Drugs Off the Market
    • Wolfe, S.1
  • 128
    • 20444389780 scopus 로고    scopus 로고
    • A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy
    • Abraham J, Davis C. 2005. A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy. Soc Sci Med 61(5):881-892.
    • (2005) Soc Sci Med , vol.61 , Issue.5 , pp. 881-892
    • Abraham, J.1    Davis, C.2
  • 131
    • 85080763013 scopus 로고    scopus 로고
    • FDA Commissioner
    • (May 21) . Letter to the Honorable George W. Bush.
    • BIO (Biotechnology Industry Organization). 2002 (May 21). FDA Commissioner. Letter to the Honorable George W. Bush.
    • (2002)
  • 133
    • 16544389833 scopus 로고    scopus 로고
    • Approval times for new drugs: does the source of funding for FDA staff matter?
    • Web Exclusives W3-618-624.
    • Carpenter D, Chernew M, Smith DG, Fendrick AM. 2003. Approval times for new drugs: does the source of funding for FDA staff matter? Health Aff (Millwood) Suppl Web Exclusives W3-618-624.
    • (2003) Health Aff (Millwood)
    • Carpenter, D.1    Chernew, M.2    Smith, D.G.3    Fendrick, A.M.4
  • 134
    • 85080672210 scopus 로고    scopus 로고
    • [Online]. Available, accessed May 19, 2006
    • CDER (Center for Drug Evaluation and Research). 2004a. Clinical Review Template, MAPP 6010.3. [Online]. Available: http://www.fda.gov/cder/mapp/6010.3.pdf [accessed May 19, 2006].
    • (2004) Clinical Review Template, MAPP 6010.3
  • 139
    • 0012213750 scopus 로고    scopus 로고
    • Public administration: from bureaucratic culture to citizen-oriented culture
    • Claver E, Llopis J, Gasco JL, Molina H, Conca FJ. 1999. Public administration: from bureaucratic culture to citizen-oriented culture. Int J Pub Sector Man 12(5):455-464.
    • (1999) Int J Pub Sector Man , vol.12 , Issue.5 , pp. 455-464
    • Claver, E.1    Llopis, J.2    Gasco, J.L.3    Molina, H.4    Conca, F.J.5
  • 141
    • 85080771651 scopus 로고    scopus 로고
    • [accessed September 14, 2006].
    • Cohn J. 2003. Politics, Profits & Pharma. [Online]. Available: http://www.pbs.org/wgbh/pages/ frontline/shows/prescription/politics/ [accessed September 14, 2006].
    • (2003) Politics, Profits & Pharma.
    • Cohn, J.1
  • 144
    • 85080657379 scopus 로고    scopus 로고
    • New Drug Safety Initiatives & the Drug Safety Oversight Board
    • (February 10) MD: Food and Drug Administration, Center for Drug Evaluation and Research.
    • Cummins SK. 2006 (February 10). New Drug Safety Initiatives & the Drug Safety Oversight Board. PowerPoint presentation to the Drug Safety and Risk Management Advisory Committee, Gaithersburg, MD: Food and Drug Administration, Center for Drug Evaluation and Research.
    • (2006) PowerPoint presentation to the Drug Safety and Risk Management Advisory Committee, Gaithersburg
    • Cummins, S.K.1
  • 145
    • 85080710864 scopus 로고
    • Final Report.
    • DHEW (Department of Health Review Panel on New Drug Regulation). 1977. Final Report.
    • (1977)
  • 149
    • 0018598351 scopus 로고
    • The drug regulation process and the challenge of regulatory reform
    • Dorsen N, Miller JM. 1979. The drug regulation process and the challenge of regulatory reform. Ann Intern Med 91(6):908-913.
    • (1979) Ann Intern Med , vol.91 , Issue.6 , pp. 908-913
    • Dorsen, N.1    Miller, J.M.2
  • 151
    • 85080663603 scopus 로고
    • [accessed June 21, 2006].
    • FDA (Food and Drug Administration). 1995. Appendix A: PDUFA Performance Goals, FY 1993-FY 1997. [Online]. Available: http://www.fda.gov/ope/pdufa/report95/appenda. html [accessed June 21, 2006].
    • (1995) Appendix A: PDUFA Performance Goals, FY 1993-FY 1997
  • 155
    • 84988618164 scopus 로고    scopus 로고
    • [Online]. Available, accessed February 23, 2005
    • FDA. 2005c. FDA Fact Sheet: FDA Improvement in Drug Safety Monitoring. [Online]. Available: http://www.fda.gov/oc/factsheets/drugsafety.html [accessed February 23, 2005].
    • (2005) FDA Fact Sheet: FDA Improvement in Drug Safety Monitoring
  • 158
    • 85080671013 scopus 로고    scopus 로고
    • [Online]. Available, accessed July 11, 2006
    • FDA. 2006a. Catalysts for Enactment of PDUFA. [Online]. Available: http://www.fda. gov/ohrms/dockets/dockets/05n0410/05n-0410-ts00010-gottleib.ppt [accessed July 11, 2006].
    • (2006) Catalysts for Enactment of PDUFA
  • 159
    • 84988543076 scopus 로고    scopus 로고
    • [Online]. Available, accessed July 12, 2006
    • FDA. 2006b. Commissioners and Their Predecessors. [Online]. Available: http://www.fda. gov/oc/commissioners/default.htm [accessed July 12, 2006].
    • (2006) Commissioners and Their Predecessors
  • 161
    • 9644302576 scopus 로고    scopus 로고
    • Postmarketing surveillance-lack of vigilance, lack of trust
    • Fontanarosa PB, Rennie D, DeAngelis CD. 2004. Postmarketing surveillance-lack of vigilance, lack of trust. JAMA 292(21):2647-2650.
    • (2004) JAMA , vol.292 , Issue.21 , pp. 2647-2650
    • Fontanarosa, P.B.1    Rennie, D.2    DeAngelis, C.D.3
  • 164
    • 84901865739 scopus 로고    scopus 로고
    • Statement of Gerald L. Dillingham, Director, Physical Infrastructure Issues. GAO-04-227T. Washington, DC: GAO.
    • GAO. 2003. Air Traffic Control FAA's Modernization Efforts-Past, Present, and Future. Statement of Gerald L. Dillingham, Director, Physical Infrastructure Issues. GAO-04-227T. Washington, DC: GAO.
    • (2003) Air Traffic Control FAA's Modernization Efforts-Past, Present, and Future
  • 170
    • 85080644227 scopus 로고    scopus 로고
    • [accessed July 17, 2006].
    • Harris G. 2005. F.D.A. Moves Toward More Openness with the Public. [Online]. Available: http://query.nytimes.com/gst/fullpage.html?sec=health&res=9A0CEFDE1E3AF933A157 51C0A9639C8B63 [accessed July 17, 2006].
    • (2005) F.D.A. Moves Toward More Openness with the Public
    • Harris, G.1
  • 171
    • 84866003221 scopus 로고    scopus 로고
    • [Online]. Available, accessed June 8, 2006
    • Harris G. 2006a. Halt Is Urged for Trials of Antibiotic in Children. [Online]. Available: http:// www.nytimes.com/2006/06/08/science/08drug.html [accessed June 8, 2006].
    • (2006) Halt Is Urged for Trials of Antibiotic in Children
  • 172
    • 85018892344 scopus 로고    scopus 로고
    • [Online]. Available, accessed July 21, 2006
    • Harris G. 2006b. Approval of Antibiotic Worried Safety Officials. [Online]. Available: http:// www.nytimes.com/2006/07/19/health/19fda.html [accessed July 21, 2006].
    • (2006) Approval of Antibiotic Worried Safety Officials
  • 173
    • 84886141964 scopus 로고    scopus 로고
    • The work of leadership. Harvard Business Review on leadership
    • Heifetz RA, Laurie DL. 1998. The work of leadership. Harvard Business Review on leadership. Harvard Business School Press. Pp. 171-199.
    • (1998) Harvard Business School Press , pp. 171-199
    • Heifetz, R.A.1    Laurie, D.L.2
  • 183
    • 85080637538 scopus 로고    scopus 로고
    • [Online]. Available, accessed December 20, 2004
    • Kaufman M. 2004b. White House Defends FDA as Drug Safety Debate Looms. [Online]. Available: http://www.washingtonpost.com/wp-dyn/articles/A11900-2004Dec19.html [accessed December 20, 2004].
    • (2004) White House Defends FDA as Drug Safety Debate Looms
  • 184
    • 0001079726 scopus 로고
    • Personality, culture, and organization
    • Kets de Vries MFR, Miller D. 1986. Personality, culture, and organization. Acad Manage Rev 11(2):266-279.
    • (1986) Acad Manage Rev , vol.11 , Issue.2 , pp. 266-279
    • Kets de Vries, M.F.R.1    Miller, D.2
  • 188
    • 85080672746 scopus 로고    scopus 로고
    • [accessed May 25, 2006].
    • Miller HI. 2006. Drug Safety: Image vs. Reality. [Online]. Available: http://www.washingtontimes. com/commentary/20060321_093254_5884r_page2.htm [accessed May 25, 2006].
    • (2006) Drug Safety: Image vs. Reality
    • Miller, H.I.1
  • 189
    • 85080743841 scopus 로고    scopus 로고
    • Drug group focuses on renewing user fee legislation
    • National Journal's Congress Daily. 2002. Drug group focuses on renewing user fee legislation. National Journal Group.
    • (2002) National Journal Group
  • 190
    • 85080743352 scopus 로고    scopus 로고
    • [accessed September 16, 2006].
    • NIH (National Institutes of Health). 2006. Charter of the Advisory Committee to the Director. [Online]. Available: http://www.nih.gov/about/director/acd/acdcharter.htm [accessed September 16, 2006].
    • (2006) Charter of the Advisory Committee to the Director
  • 193
    • 14944360098 scopus 로고    scopus 로고
    • What ails the FDA?
    • Okie S. 2005. What ails the FDA? N Engl J Med 352(11):1063-1066.
    • (2005) N Engl J Med , vol.352 , Issue.11 , pp. 1063-1066
    • Okie, S.1
  • 195
    • 84990054307 scopus 로고    scopus 로고
    • (May) Harvard Business Review
    • Ostroff F. 2006 (May). Change in Management in Government. Harvard Business Review. PricewaterhouseCoopers' Health Research Institute. 2005. Recapturing the Vision: Integrity Driven Performance in the Pharmaceutical Industry. [Online]. Available: http://www. pwc.com/extweb/pwcpublications.nsf/docid/EE74BACB6DE454768525702A00630CFF [accessed March 10, 2006].
    • (2006) Change in Management in Government
    • Ostroff, F.1
  • 197
    • 85080712428 scopus 로고    scopus 로고
    • PowerPoint presentation, presented at the Institute of Medicine Workshop on Advancing the Methods and Application of Risk-Benefit Assessment of Medicines, Washington, DC. Institute of Medicine Committee on the Assessment of the US Drug Safety System.
    • Racoosin JA. 2006 (January 17). Pre-Marketing Assessment of Drug Safety. PowerPoint presentation, presented at the Institute of Medicine Workshop on Advancing the Methods and Application of Risk-Benefit Assessment of Medicines, Washington, DC. Institute of Medicine Committee on the Assessment of the US Drug Safety System.
    • (2006) Pre-Marketing Assessment of Drug Safety
    • Racoosin, J.A.1
  • 198
    • 30444449389 scopus 로고    scopus 로고
    • Reform of drug regulation-beyond an independent drug-safety board
    • Ray WA, Stein CM. 2006. Reform of drug regulation-beyond an independent drug-safety board. N Engl J Med 354(2):194-201.
    • (2006) N Engl J Med , vol.354 , Issue.2 , pp. 194-201
    • Ray, W.A.1    Stein, C.M.2
  • 199
    • 85080733926 scopus 로고    scopus 로고
    • Final Report of the Return to Flight Task Group: Assessing the Implementation of the Columbia Accident Investigation Board Return-to-Flight Recommendations.
    • Return to Flight Task Group. 2005. Final Report of the Return to Flight Task Group: Assessing the Implementation of the Columbia Accident Investigation Board Return-to-Flight Recommendations.
    • (2005)
  • 201
    • 85080698513 scopus 로고    scopus 로고
    • FDA at 100: alumni take its temperature: as the Food and Drug Administration prepares to celebrate its centenary
    • Ross W. 2006. FDA at 100: alumni take its temperature: as the Food and Drug Administration prepares to celebrate its centenary. Med Mark & Media 41(5):52-56.
    • (2006) Med Mark & Media , vol.41 , Issue.5 , pp. 52-56
    • Ross, W.1
  • 204
    • 33745623987 scopus 로고    scopus 로고
    • The Food and Drug Administration's use of postmarketing (Phase IV) study requirements: exception to the rule?
    • Steenburg C. 2006. The Food and Drug Administration's use of postmarketing (Phase IV) study requirements: exception to the rule? Food Drug Law J 61(2):1-91.
    • (2006) Food Drug Law J , vol.61 , Issue.2 , pp. 1-91
    • Steenburg, C.1
  • 205
    • 0000456233 scopus 로고
    • The theory of economic regulation
    • Stigler G. 1971. The theory of economic regulation. Bell J Econ Manage Sci 2:2-21.
    • (1971) Bell J Econ Manage Sci , vol.2 , pp. 2-21
    • Stigler, G.1
  • 207
    • 33645653562 scopus 로고    scopus 로고
    • Drug safety withdrawals in the US not linked to speed of FDA approval
    • Tufts Center for the Study of Drug Development. 2005. Drug safety withdrawals in the US not linked to speed of FDA approval. Tufts Center for the Study of Drug Development. Tufts CSDD Impact Report 7(5):1-4.
    • (2005) Tufts Center for the Study of Drug Development. Tufts CSDD Impact Report , vol.7 , Issue.5 , pp. 1-4
  • 208
    • 85080731024 scopus 로고    scopus 로고
    • [Online]. Available, accessed August 9, 2006
    • UCS (Union of Concerned Scientists). 2006a. Acting FDA Director Pledges to Address Abuse of Science. [Online]. Available: http://www.ucsusa.org/news/press_release/acting-fdadirector- pledges.html [accessed August 9, 2006].
    • (2006) Acting FDA Director Pledges to Address Abuse of Science
  • 210
    • 85080771832 scopus 로고    scopus 로고
    • PhRMA opposes user fees for further FDA enforcement
    • (January 1)
    • Validation Times. 2002 (January 1). PhRMA opposes user fees for further FDA enforcement. Validation Times 4(1). von Eschenbach A. 2006. Nomination Hearing. Statement at the Aug. 1, 2006 Hearing of the Committee on Senate Committee on Health, Education, Labor, and Pensions.
    • (2002) Validation Times , vol.4 , Issue.1
  • 211
    • 85080741789 scopus 로고    scopus 로고
    • Nomination Hearing
    • Statement at the Aug. 1, 2006 Hearing of the Committee on Senate Committee on Health, Education, Labor, and Pensions.
    • von Eschenbach A. 2006. Nomination Hearing. Statement at the Aug. 1, 2006 Hearing of the Committee on Senate Committee on Health, Education, Labor, and Pensions.
    • (2006)
    • von Eschenbach, A.1
  • 213
    • 76149099019 scopus 로고    scopus 로고
    • accessed [September 16, 2006].
    • Wall Street Journal and Harris Interactive. 2006. The FDA's Reputation with the General Public Is Under Assault. [Online]. Available: http://www.harrisinteractive.com/news/ newsletters/wsjhealthnews/WSJOnline_HI_Health-CarePoll2006vol5_iss09.pdf. accessed [September 16, 2006].
    • (2006) The FDA's Reputation with the General Public Is Under Assault
  • 214
    • 85080748182 scopus 로고    scopus 로고
    • [accessed July 26, 2006].
    • Washington Drug Letter. 2006. Crawford Reverses Stance on Plan B Testimony. [Online]. Available: http://www.nexis.com [accessed July 26, 2006].
    • (2006) Crawford Reverses Stance on Plan B Testimony
  • 219
    • 23444458067 scopus 로고    scopus 로고
    • The Prescription Drug User Fee Act: is a faster Food and Drug Administration always a better Food and Drug Administration?
    • Zelenay JL. 2005. The Prescription Drug User Fee Act: is a faster Food and Drug Administration always a better Food and Drug Administration? Food Drug Law J 60(2):261-338.
    • (2005) Food Drug Law J , vol.60 , Issue.2 , pp. 261-338
    • Zelenay, J.L.1
  • 223
    • 85080659257 scopus 로고    scopus 로고
    • [accessed September 14, 2006].
    • CERTS (Centers for Education & Research on Therapeutics). 2006. Ongoing Projects. [Online]. Available: http://certs.hhs.gov/projects/ongoing.html [accessed September 14, 2006].
    • (2006) Ongoing Projects
  • 226
    • 84858457134 scopus 로고    scopus 로고
    • [accessed August 14, 2006].
    • Clinicalstudyresults.org. 2006. Glossary. [Online]. Available: http://www.clinicalstudyresults. org/glossary/#hypothesis [accessed August 14, 2006].
    • (2006) Glossary
  • 227
    • 33646885494 scopus 로고    scopus 로고
    • Stimulant medications and attention deficithyperactivity disorder
    • Cohen AL, Jhung MA, Budnitz DS. 2006. Stimulant medications and attention deficithyperactivity disorder. N Engl J Med 354(21):2294-2295.
    • (2006) N Engl J Med , vol.354 , Issue.21 , pp. 2294-2295
    • Cohen, A.L.1    Jhung, M.A.2    Budnitz, D.S.3
  • 228
    • 85080710311 scopus 로고    scopus 로고
    • Vaccine Safety Datalink: Overview. Presentation to the Committee on Review of NIP's Research Procedures and Data Sharing Program. Washington, DC: Insitute of Medicine.
    • Davis R. 2004 (August 23). Vaccine Safety Datalink: Overview. Presentation to the Committee on Review of NIP's Research Procedures and Data Sharing Program. Washington, DC: Insitute of Medicine.
    • (2004)
    • Davis, R.1
  • 231
    • 85080751445 scopus 로고    scopus 로고
    • [accessed February 13, 2006].
    • DHHS, FDA (Food and Drug Administration), CDER (Center for Drug Evaluation and Research). 2005. FDA's Communication of Drug Safety Information: Transcript, December 8, 2005. [Online]. Available: http://www.fda.gov/cder/meeting/RiskComm2005/1208fda. pdf [accessed February 13, 2006].
    • (2005) FDA's Communication of Drug Safety Information: Transcript, December 8, 2005
  • 236
    • 34247343738 scopus 로고    scopus 로고
    • [accessed September 18, 2006].
    • CDER (Center for Drug Evaluation and Research). 2006. Medication Guides. [Online]. Available: http://www.fda.gov/cder/Offices/ODS/medication_guides.htm [accessed September 18, 2006].
    • (2006) Medication Guides
  • 239
    • 0036421576 scopus 로고    scopus 로고
    • The effects of the internet on pharmaceutical consumers and providers
    • Dupuits FMHM. 2002. The effects of the internet on pharmaceutical consumers and providers. Dis Manage Outcomes 10(11):679-691.
    • (2002) Dis Manage Outcomes , vol.10 , Issue.11 , pp. 679-691
    • Dupuits, F.M.H.M.1
  • 240
    • 85080653669 scopus 로고    scopus 로고
    • [accessed April 18, 2006].
    • FDA (Food and Drug Administration). 2003. Advisory Committee Oversight and Management Staff. [Online]. Available: http://www.fda.gov/oc/advisory/missionandstaff.html [accessed April 18, 2006].
    • (2003) Advisory Committee Oversight and Management Staff
  • 243
    • 84899725523 scopus 로고    scopus 로고
    • Information, paternalism, and rational decision-making: the balance of FDA new drug approval
    • Greenberg MD. 2003. Information, paternalism, and rational decision-making: the balance of FDA new drug approval. Alb L J Sci & Tech Summer/Fall:1-16.
    • (2003) Alb L J Sci & Tech , pp. 1-16
    • Greenberg, M.D.1
  • 244
    • 0141959095 scopus 로고    scopus 로고
    • "Ignorance is bliss sometimes": constraints on the emergence of the "informed patient" in the changing landscapes of health information
    • Henwood F, Wyatt S, Hart A, Smith J. 2003. "Ignorance is bliss sometimes": constraints on the emergence of the "informed patient" in the changing landscapes of health information. Sociol Health Illn 25(6):589-607.
    • (2003) Sociol Health Illn , vol.25 , Issue.6 , pp. 589-607
    • Henwood, F.1    Wyatt, S.2    Hart, A.3    Smith, J.4
  • 246
    • 2942539424 scopus 로고    scopus 로고
    • Washington, DC: The National Academies Press.
    • IOM (Institute of Medicine). 2005. Health Literacy: A Prescription to End Confusion. Washington, DC: The National Academies Press.
    • (2005) Health Literacy: A Prescription to End Confusion
  • 248
  • 250
    • 85080650386 scopus 로고    scopus 로고
    • [accessed April 20, 2006].
    • NCI (National Cancer Institute). 2006a. Director's Consumer Liaison Group: Charter Summary. [Online]. Available: http://deainfo.nci.nih.gov/advisory/dclg/dclgchr.htm [accessed April 20, 2006].
    • (2006) Director's Consumer Liaison Group: Charter Summary
  • 251
    • 85080726075 scopus 로고    scopus 로고
    • [accessed April 20, 2006].
    • NCI. 2006b. Director's Consumer Liaison Group: Fact Sheet. [Online]. Available: http:// la.cancer.gov/DCLGFactSheet2006.pdf [accessed April 20, 2006].
    • (2006) Director's Consumer Liaison Group: Fact Sheet
  • 252
    • 85080721443 scopus 로고    scopus 로고
    • [accessed June 8, 2006].
    • NCI, Office of Liaison Activities. 2006c. Listening and Learning Together: Building a Bridge of Trust. [Online]. Available: http://www.palladianpartners.com/NCISummit2006/welcome. htm [accessed June 8, 2006].
    • (2006) Listening and Learning Together: Building a Bridge of Trust
  • 253
    • 85080686392 scopus 로고    scopus 로고
    • [accessed July 13, 2006].
    • NIH (National Institutes of Health). 2006. About COPR. [Online]. Available: http://copr.nih. gov/mission.asp [accessed July 13, 2006].
    • (2006) About COPR
  • 258
    • 0003739983 scopus 로고    scopus 로고
    • [accessed July 18, 2006].
    • Steering Committee for the Collaborative Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information.1996. Action Plan for the Provision of Useful Prescription Medicine Information. [Online]. Available: http://www.fda. gov/cder/offices/ods/keystone.pdf [accessed July 18, 2006].
    • (1996) Action Plan for the Provision of Useful Prescription Medicine Information
  • 259
    • 85080717234 scopus 로고    scopus 로고
    • Power- Point presentation to the FDA Science Advisory Board. Bethesda, MD: FDA.
    • Throckmorton DC. 2006 (March 31). Drug Safety Oversight Board: Recent Activities. Power- Point presentation to the FDA Science Advisory Board. Bethesda, MD: FDA.
    • (2006) Drug Safety Oversight Board: Recent Activities
    • Throckmorton, D.C.1
  • 261
    • 85080650386 scopus 로고    scopus 로고
    • [Online]. Available, accessed April 20, 2006
    • NCI (National Cancer Institute). 2006a. Director's Consumer Liaison Group: Charter Summary. [Online]. Available: http://deainfo.nci.nih.gov/advisory/dclg/dclgchr.htm [accessed April 20, 2006].
    • (2006) Director's Consumer Liaison Group: Charter Summary
  • 262
    • 85080726075 scopus 로고    scopus 로고
    • [Online]. Available, accessed April 20, 2006
    • NCI. 2006b. Director's Consumer Liaison Group: Fact Sheet. [Online]. Available: http:// la.cancer.gov/DCLGFactSheet2006.pdf [accessed April 20, 2006].
    • (2006) Director's Consumer Liaison Group: Fact Sheet
  • 263
    • 85080721443 scopus 로고    scopus 로고
    • [Online]. Available, accessed June 8, 2006
    • NCI, Office of Liaison Activities. 2006c. Listening and Learning Together: Building a Bridge of Trust. [Online]. Available: http://www.palladianpartners.com/NCISummit2006/welcome. htm [accessed June 8, 2006].
    • (2006) Listening and Learning Together: Building a Bridge of Trust
  • 264
    • 85080686392 scopus 로고    scopus 로고
    • About COPR
    • [accessed July 13, 2006].
    • NIH (National Institutes of Health). 2006. About COPR. [Online]. Available: http://copr.nih. gov/mission.asp [accessed July 13, 2006].
    • (2006)
  • 265
    • 1242280858 scopus 로고    scopus 로고
    • Internet Health Resources: Health Searches and Email Have Become More Commonplace, but There Is Room for Improvement in Searches and Overall Internet Access
    • [accessed October 14, 2005].
    • Pew Internet & American Life Project. 2003. Internet Health Resources: Health Searches and Email Have Become More Commonplace, but There Is Room for Improvement in Searches and Overall Internet Access. [Online]. Available: http://www.pewinternet.org/ pdfs/PIP_Health_Report_July_2003.pdf [accessed October 14, 2005].
    • (2003)
  • 266
    • 33845912551 scopus 로고    scopus 로고
    • Prescription Drugs Online: One in Four Americans Have Looked Online for Drug Information, But Few Have Ventured into the Online Drug Marketplace
    • [accessed Octpber 17, 2005].
    • Pew Internet & American Life Project. 2004. Prescription Drugs Online: One in Four Americans Have Looked Online for Drug Information, But Few Have Ventured into the Online Drug Marketplace. [Online]. Available: http://www.pewinternet.org/pdfs/PIP_Prescription_ Drugs_Online.pdf [accessed Octpber 17, 2005].
    • (2004)
  • 267
    • 28044450027 scopus 로고    scopus 로고
    • Health Information Online: Eight in Ten Internet Users Have Looked for Health Information Online, With Increased Interest in Diet, Fitness, Drugs, Health Insurance, Experimental Treatments, and Particular Doctors and Hospitals
    • [accessed October 17, 2005].
    • Pew Internet & American Life Project. 2005. Health Information Online: Eight in Ten Internet Users Have Looked for Health Information Online, With Increased Interest in Diet, Fitness, Drugs, Health Insurance, Experimental Treatments, and Particular Doctors and Hospitals. [Online]. Available: http://www.pewinternet.org/pdfs/PIP_Healthtopics_ May05.pdf [accessed October 17, 2005].
    • (2005)
  • 269
    • 0003739983 scopus 로고    scopus 로고
    • Action Plan for the Provision of Useful Prescription Medicine Information
    • [accessed July 18, 2006].
    • Steering Committee for the Collaborative Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information.1996. Action Plan for the Provision of Useful Prescription Medicine Information. [Online]. Available: http://www.fda. gov/cder/offices/ods/keystone.pdf [accessed July 18, 2006].
    • (1996)
  • 270
    • 85080717234 scopus 로고    scopus 로고
    • Drug Safety Oversight Board: Recent Activities
    • March 31, Power- Point presentation to the FDA Science Advisory Board. Bethesda, MD: FDA.
    • Throckmorton DC. 2006 (March 31). Drug Safety Oversight Board: Recent Activities. Power- Point presentation to the FDA Science Advisory Board. Bethesda, MD: FDA.
    • (2006)
    • Throckmorton, D.C.1
  • 271
    • 85080675715 scopus 로고    scopus 로고
    • Statement by Janet Woodcock, MD, Director, Center for Drug Administration Before the Subcommittee on Oversight and Investigations before the Committee on Energy and Commerce, US House of Representatives.
    • Woodcock J. 2002. Statement by Janet Woodcock, MD, Director, Center for Drug Administration Before the Subcommittee on Oversight and Investigations before the Committee on Energy and Commerce, US House of Representatives.
    • (2002)
    • Woodcock, J.1
  • 272
    • 85080639330 scopus 로고    scopus 로고
    • A Theory of Approval Regulation
    • [accessed October 10, 2005].
    • Carpenter D, Ting MM. 2004. A Theory of Approval Regulation. [Online]. Available: http://people.hmdc.harvard.edu/~dcarpent/endosub-20040214.pdf [accessed October 10, 2005].
    • (2004)
    • Carpenter, D.1    Ting, M.M.2
  • 273
    • 9644269507 scopus 로고    scopus 로고
    • FDA's Review Process for New Drug Applications: a Management Review
    • OEI-01-01- 00590. Washington, DC: OIG, FDA.
    • DHHS (Department of Health and Human Services), OIG (Office of Inspector General). 2003. FDA's Review Process for New Drug Applications: a Management Review. OEI-01-01- 00590. Washington, DC: OIG, FDA.
    • (2003)
  • 274
    • 12144258403 scopus 로고    scopus 로고
    • PDUFA III Five Year Plan
    • [accessed October 10, 2005].
    • FDA (Food and Drug Administration). 2003. PDUFA III Five Year Plan. [Online]. Available: http://www.fda.gov/oc/pdufa3/2003plan/default.htm [accessed October 10, 2005].
    • (2003)
  • 275
    • 85080733265 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research-Activities and Level of Effort Devoted to Drug Safety
    • Submitted to the Institute of Medicine Committee on the Assessment of the US Drug Safety System by FDA.
    • FDA. 2005a. Center for Drug Evaluation and Research-Activities and Level of Effort Devoted to Drug Safety. Submitted to the Institute of Medicine Committee on the Assessment of the US Drug Safety System by FDA.
    • (2005)
  • 277
    • 85080726879 scopus 로고    scopus 로고
    • Prepared Testimony of Richard Platt
    • MD, MSC, Professor of Ambulatory Care and Prevention Harvard Medical School Director of Research Harvard Pilgrim Health Care.
    • Federal News Service. 2000. Prepared Testimony of Richard Platt, MD, MSC, Professor of Ambulatory Care and Prevention Harvard Medical School Director of Research Harvard Pilgrim Health Care.
    • (2000)
  • 278
    • 2542465496 scopus 로고    scopus 로고
    • Food and Drug Administration: Effect of User Fees on Drug Approval Times
    • Withdrawals, and Other Agency Activities. GAO-02-958. Washington, DC: GAO.
    • GAO. 2002. Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities. GAO-02-958. Washington, DC: GAO.
    • (2002)
  • 279
    • 33646761376 scopus 로고    scopus 로고
    • Drug Safety: Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process
    • GAO-06-402. Washington, DC: GAO.
    • GAO. 2006. Drug Safety: Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process. GAO-06-402. Washington, DC: GAO.
    • (2006)
  • 280
    • 85080687576 scopus 로고    scopus 로고
    • Statement of the Pharmaceutical Research and Manufacturers of America to Institute of Medicine
    • Presentation to the Institute of Medicine Committee on the Assessment of the US Drug Safety System. Washington, DC: IOM.
    • Goldhammer A. 2005 (June 8). Statement of the Pharmaceutical Research and Manufacturers of America to Institute of Medicine. Presentation to the Institute of Medicine Committee on the Assessment of the US Drug Safety System. Washington, DC: IOM.
    • (2005)
    • Goldhammer, A.1
  • 281
    • 0001184193 scopus 로고
    • The politics of government decision-making: a theory of regulatory capture
    • Laffont J, Tirole J. 1991. The politics of government decision-making: a theory of regulatory capture. Quart J Econ 106(4):1089-1127.
    • (1991) Quart J Econ , vol.106 , Issue.4 , pp. 1089-1127
    • Laffont, J.1    Tirole, J.2
  • 282
    • 0000456233 scopus 로고
    • The theory of economic regulation
    • Stigler G. 1971. The theory of economic regulation. Bell J Econ Manage Sci 2:2-21.
    • (1971) Bell J Econ Manage Sci , vol.2 , pp. 2-21
    • Stigler, G.1
  • 284
    • 84909213519 scopus 로고    scopus 로고
    • FDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear Retaliation for Voicing Safety Concerns
    • Union of Concerned Scientists (UCS). 2006. FDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear Retaliation for Voicing Safety Concerns. [Online]. Available: http://www.ucsusa.org/news/press_release/fda-scientists-pressured.html [accessed July 24, 2006].
    • (2006)
  • 285
    • 55649085731 scopus 로고    scopus 로고
    • Public Citizen: The 100th Anniversary of the FDA: The Sleeping Watchdog Whose Master Is Increasingly the Regulated Industries
    • Wolfe S. 2006. Public Citizen: The 100th Anniversary of the FDA: The Sleeping Watchdog Whose Master Is Increasingly the Regulated Industries. [Online]. Available: http://www. pharmalive.com/News/index.cfm?articleid=353196&categoryid=54 [accessed July 11, 2006].
    • (2006)
    • Wolfe, S.1
  • 286
    • 23444458067 scopus 로고    scopus 로고
    • The Prescription Drug User Fee Act: is a faster Food and Drug Administration always a better Food and Drug Administration?
    • Zelenay JL. 2005. The Prescription Drug User Fee Act: is a faster Food and Drug Administration always a better Food and Drug Administration? Food Drug Law J 60(2):261-338.
    • (2005) Food Drug Law J , vol.60 , Issue.2 , pp. 261-338
    • Zelenay, J.L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.