-
2
-
-
84860080778
-
-
Rockville, Md.: Food and Drug Administration
-
FY 2004 Justification of Estimates for Appropriations Committees. Promoting public health through patient, food, and consumer safety. Rockville, Md.: Food and Drug Administration, 2003. (Accessed December 30, 2004, at http://www.fda.gov/oc/oms/ofm/budget/2004/bib1.htm.)
-
(2003)
Promoting Public Health Through Patient, Food, and Consumer Safety
-
-
-
3
-
-
84860085191
-
CDC, NIH, FAA, FDA get highest ratings of eleven federal government agencies
-
Taylor H. CDC, NIH, FAA, FDA get highest ratings of eleven federal government agencies. Harris Poll no. 73. (Accessed December 30, 2004, at http://www.harrisinteractive.com/harris_poll/index.asp?PID=422.)
-
Harris Poll No. 73
-
-
Taylor, H.1
-
4
-
-
0004207615
-
-
New York: Doubleday, Page
-
Sinclair U. The jungle. New York: Doubleday, Page, 1906:102.
-
(1906)
The Jungle
, pp. 102
-
-
Sinclair, U.1
-
5
-
-
0343427072
-
-
Pub. L. No. 102-571, 21 U.S.C. 379, 106 Stat. 4491 (Oct. 29, 1992)
-
Prescription Drug User Fee Act of 1992, Pub. L. No. 102-571, 21 U.S.C. 379, 106 Stat. 4491 (Oct. 29, 1992).
-
Prescription Drug User Fee Act of 1992
-
-
-
8
-
-
12144258403
-
-
Rockville, Md.: Food and Drug Administration, July
-
PDUFA III: five-year plan. Rockville, Md.: Food and Drug Administration, July 2003. (Accessed December 30, 2004, at http://www.fda.gov/oc/pdufa3/ 2003plan/default.htm.)
-
(2003)
PDUFA III: Five-year Plan
-
-
-
9
-
-
84860081533
-
-
Rockville, Md.: Food and Drug Administration
-
Office of Planning. PDUFA III commitments: new goals and approaches. Rockville, Md.: Food and Drug Administration, 2003. (Accessed December 30, 2004, at http://www.fda.gov/oc/pdufa/report2002/2002-PDUFAIIICommitments.html.)
-
(2003)
PDUFA III Commitments: New Goals and Approaches
-
-
-
10
-
-
84860085185
-
-
Department of Health and Human Services. Washington, D.C.; Office of Management and Budget, 2004.
-
Department of Health and Human Services. Washington, D.C.; Office of Management and Budget, 2004. (Accessed December 30, 2004, at http://www.whitehouse.gov/omb/budget/fy2005/print/hhs.html.)
-
-
-
-
11
-
-
84860090806
-
-
Rockville, Md.: Food and Drug Administration
-
FDA's budget proposal for FY 2004. Rockville, Md.: Food and Drug Administration, 2003. (Accessed December 30, 2004, at http://www.fda.gov/bbs/ topic/ANSWERS/2003/ANS01195.html.)
-
(2003)
FDA's Budget Proposal for FY 2004
-
-
-
12
-
-
84860086526
-
-
Department of Agriculture. Washington, D.C.: Office of Management and Budget, 2004
-
Department of Agriculture. Washington, D.C.: Office of Management and Budget, 2004. (Accessed December 30, 2004, at http://www.whitehouse.gov/omb/ budget/fy2005/agriculture.html.)
-
-
-
-
14
-
-
0038354516
-
Remarks of the Commissioner of Food and Drugs
-
McClellan MB. Remarks of the Commissioner of Food and Drugs. Food Drug Law J 2003;58:191-204.
-
(2003)
Food Drug Law J
, vol.58
, pp. 191-204
-
-
McClellan, M.B.1
-
17
-
-
12144257989
-
The pink sheet: FDA clears 21 NMEs in 2003; average approval time is 16.6 months
-
The pink sheet: FDA clears 21 NMEs in 2003; average approval time is 16.6 months. Pink Sheet 2004;66:1-3.
-
(2004)
Pink Sheet
, vol.66
, pp. 1-3
-
-
-
20
-
-
84860090827
-
-
Rockville, Md.: Food and Drug Administration
-
Office of Planning. Report on PDUFA goals: original new product applications. Rockville, Md.: Food and Drug Administration, 2003. (Accessed December 30, 2004, at http://www.fda.gov/oc/pdufa/report2002/2002-onpa.html.)
-
(2003)
Report on PDUFA Goals: Original New Product Applications
-
-
-
21
-
-
0037108228
-
Policy developments in regulatory approval
-
Temple R. Policy developments in regulatory approval. Stat Med 2002;21:2939-48.
-
(2002)
Stat Med
, vol.21
, pp. 2939-2948
-
-
Temple, R.1
-
22
-
-
34248382894
-
The changing regulatory environment: Reality and perception
-
Surrey, England: Centre for Medicines Research, August
-
McAuslane N, Anderson C, Walker S. The changing regulatory environment: reality and perception. R&D briefing no. 42. Surrey, England: Centre for Medicines Research, August 2004.
-
(2004)
R&D Briefing No. 42
-
-
McAuslane, N.1
Anderson, C.2
Walker, S.3
-
24
-
-
0037374498
-
The price of innovation: New estimates of drug development costs
-
DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003;22:151-85.
-
(2003)
J Health Econ
, vol.22
, pp. 151-185
-
-
DiMasi, J.A.1
Hansen, R.W.2
Grabowski, H.G.3
-
25
-
-
0037710438
-
-
September 17, 2002. Washington, D.C.: General Accountability Office, GAO-02-958
-
Food and Drug Administration. Effect of user fees on drug approval times, withdrawals, and other agency activities. September 17, 2002. Washington, D.C.: General Accountability Office, 2002. (GAO-02-958.) (Accessed December 30, 2004, at http://www.gao.gov/docdblite/summary.php?recflag=&accno= A05090&rptno=GAO-02-958.)
-
(2002)
Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities
-
-
-
26
-
-
0347742368
-
-
Washington, D.C.: General Accountability Office, January GAO-03-101
-
Major management challenges and program risks. Washington, D.C.: General Accountability Office, January 2003:46-75. (GAO-03-101.)
-
(2003)
Major Management Challenges and Program Risks
, pp. 46-75
-
-
-
27
-
-
0033549087
-
The safely 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. The safely of newly approved medicines: do recent market removals mean there is a problem? JAMA 1999;281:1728-34.
-
(1999)
JAMA
, vol.281
, 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
-
28
-
-
0023767292
-
Clinical profile of angioedema associated with angiotensin converting-enzyme inhibition
-
Slater EE, Merrill DD, Guess HA, et al. Clinical profile of angioedema associated with angiotensin converting-enzyme inhibition. JAMA 1988;260:967-70.
-
(1988)
JAMA
, vol.260
, pp. 967-970
-
-
Slater, E.E.1
Merrill, D.D.2
Guess, H.A.3
-
29
-
-
0034298524
-
Fat redistribution on indinavir-treated patients with HIV infection: A review of postmarketing cases
-
Benson JO, McGhee K, Coplan P, et al. Fat redistribution on indinavir-treated patients with HIV infection: a review of postmarketing cases. J Acquir Immune Defic Syndr 2000;25:130-9.
-
(2000)
J Acquir Immune Defic Syndr
, vol.25
, pp. 130-139
-
-
Benson, J.O.1
McGhee, K.2
Coplan, P.3
-
30
-
-
7044246370
-
-
Whitehouse Station, N.J.: Merck
-
Merck announces voluntary worldwide withdrawal of Vioxx. Whitehouse Station, N.J.: Merck, 2004. (Accessed December 30, 2004, at http://www.merck. com/newsroom/press_releases/product/2004_0930.html.)
-
(2004)
Merck Announces Voluntary Worldwide Withdrawal of Vioxx
-
-
-
31
-
-
0035832506
-
Lessons from the glitazones: A story of drug development
-
Gale EA. Lessons from the glitazones: a story of drug development. Lancet 2001;357:1870-5.
-
(2001)
Lancet
, vol.357
, pp. 1870-1875
-
-
Gale, E.A.1
-
34
-
-
4644260256
-
Expecting the unexpected - Drug safely, pharmacovigilance, and the prepared mind
-
Trontell A. Expecting the unexpected - drug safely, pharmacovigilance, and the prepared mind. N Engl J Med 2004;351:1385-7.
-
(2004)
N Engl J Med
, vol.351
, pp. 1385-1387
-
-
Trontell, A.1
-
35
-
-
0038931405
-
Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system
-
DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat 1999;53:177-90.
-
(1999)
Am Stat
, vol.53
, pp. 177-190
-
-
DuMouchel, W.1
-
36
-
-
0037467485
-
FDA: Untapped source of unpublished trials
-
Bennett DA, Jull A. FDA: untapped source of unpublished trials. Lancet 2003;361:1402-3.
-
(2003)
Lancet
, vol.361
, pp. 1402-1403
-
-
Bennett, D.A.1
Jull, A.2
-
39
-
-
0029997956
-
Shattuck Lecture - Evaluating the health risks of breast implants: The interplay of medical science, the law, and public opinion
-
Angell M. Shattuck Lecture - evaluating the health risks of breast implants: the interplay of medical science, the law, and public opinion. N Engl J Med 1996;334:1513-8.
-
(1996)
N Engl J Med
, vol.334
, pp. 1513-1518
-
-
Angell, M.1
-
40
-
-
0036569927
-
Safety of newly approved drugs: Implications for prescribing
-
Temple RJ, Himmel MH. Safety of newly approved drugs: implications for prescribing. JAMA 2002;287:2273-5.
-
(2002)
JAMA
, vol.287
, pp. 2273-2275
-
-
Temple, R.J.1
Himmel, M.H.2
-
42
-
-
9644253392
-
Celebrex drama may finally prompt changes at the FDA
-
December 20
-
Wilde Mathews A, Martinez B. Celebrex drama may finally prompt changes at the FDA. Wall Street Journal. December 20, 2004:B1.
-
(2004)
Wall Street Journal
-
-
Wilde Mathews, A.1
Martinez, B.2
-
43
-
-
0344874660
-
Rx: Canadian drugs
-
Zuger A. Rx: Canadian drugs. N Engl J Med 2003;349:2188-90.
-
(2003)
N Engl J Med
, vol.349
, pp. 2188-2190
-
-
Zuger, A.1
-
48
-
-
2442656495
-
Pitfalls of converting practice guidelines into quality measures: Lessons learned from a VA performance measure
-
Walter LC, Davidowitz NP, Heineken PA, Covinsky KE. Pitfalls of converting practice guidelines into quality measures: lessons learned from a VA performance measure. JAMA 2004;291:2466-70.
-
(2004)
JAMA
, vol.291
, pp. 2466-2470
-
-
Walter, L.C.1
Davidowitz, N.P.2
Heineken, P.A.3
Covinsky, K.E.4
-
49
-
-
4644316823
-
NICE work - Providing guidance to the British National Health Service
-
Rawlins MD. NICE work - providing guidance to the British National Health Service. N Engl J Med 2004;351:1383-5.
-
(2004)
N Engl J Med
, vol.351
, pp. 1383-1385
-
-
Rawlins, M.D.1
-
50
-
-
0037048941
-
The pharmaceutical industry as a political player
-
Abraham J. The pharmaceutical industry as a political player. Lancet 2002;360:1498-502.
-
(2002)
Lancet
, vol.360
, pp. 1498-1502
-
-
Abraham, J.1
-
51
-
-
0035912536
-
Lotronex and the FDA: A fatal erosion of integrity
-
Horton R. Lotronex and the FDA: a fatal erosion of integrity. Lancet 2001;357:1544-5.
-
(2001)
Lancet
, vol.357
, pp. 1544-1545
-
-
Horton, R.1
-
52
-
-
0035806749
-
The FDA and the Lancet: An exchange
-
Galson S, Kweder S, Houn F, Raczowski V, Honig PK. The FDA and the Lancet: an exchange. Lancet 2001;358:415.
-
(2001)
Lancet
, vol.358
, pp. 415
-
-
Galson, S.1
Kweder, S.2
Houn, F.3
Raczowski, V.4
Honig, P.K.5
-
53
-
-
11144332231
-
Financial relationships and interests in research involving human subjects: Guidance for human subject protection
-
Department of Health and Human Services. Financial relationships and interests in research involving human subjects: guidance for human subject protection. Fed Regist 2004;69(92):26393-7.
-
(2004)
Fed Regist
, vol.69
, Issue.92
, pp. 26393-26397
-
-
-
54
-
-
0038016469
-
Financial conflict of interest in medical research: Overview and analysis of institutional controls
-
Henderson JA, Smith JJ. Financial conflict of interest in medical research: overview and analysis of institutional controls. Food Drug Law J 2003;58:251-68.
-
(2003)
Food Drug Law J
, vol.58
, pp. 251-268
-
-
Henderson, J.A.1
Smith, J.J.2
|