-
1
-
-
34248583513
-
Risks and benefits of risk-management plans
-
May/Jun
-
Meltzer D. Risks and benefits of risk-management plans. Health Aff 2007 May/Jun; 26 (3): 681-683
-
(2007)
Health Aff
, vol.26
, Issue.3
, pp. 681-683
-
-
Meltzer, D.1
-
2
-
-
34248594707
-
Drug safety proposals and the intrusion of fed-eral regulation into patient freedom and medical practice
-
May/Jun
-
Gottlieb S. Drug safety proposals and the intrusion of fed-eral regulation into patient freedom and medical practice. Health Aff 2007 May/Jun; 26 (3): 664-677
-
(2007)
Health Aff
, vol.26
, Issue.3
, pp. 664-677
-
-
Gottlieb, S.1
-
3
-
-
50949129257
-
Drug warnings that can cause fits: Communicating risks in a data-poor environment
-
Sep 4
-
Avorn J. Drug warnings that can cause fits: communicating risks in a data-poor environment. N Engl J Med 2008 Sep 4; 359 (10): 991-994
-
(2008)
N Engl J Med
, vol.359
, Issue.10
, pp. 991-994
-
-
Avorn, J.1
-
4
-
-
1542783234
-
Nature of preventable adverse drug events in hospitals: A literature review
-
Sep
-
Kanjanarat P, Winterstein AG, Johns TE, et al. Nature of preventable adverse drug events in hospitals: a literature review. Am J Health Syst Pharm 2003 Sep; 60: 1750-1759
-
(2003)
Am J Health Syst Pharm
, vol.60
, pp. 1750-1759
-
-
Kanjanarat, P.1
Winterstein, A.G.2
Johns, T.E.3
-
5
-
-
0037420292
-
Medication safety: Moving from illusion to rea-lity
-
Mar 5
-
Classen D. Medication safety: moving from illusion to rea-lity. JAMA 2003 Mar 5; 289 (9): 1154-1156
-
(2003)
JAMA
, vol.289
, Issue.9
, pp. 1154-1156
-
-
Classen, D.1
-
6
-
-
0346147013
-
Improving medication safety: The measurement conundrum and where to start
-
Classen DC, Metzger J. Improving medication safety: the measurement conundrum and where to start. Int J Qual Health Care 2003; 15 Suppl. I: i41-7
-
(2003)
Int J Qual Health Care
, vol.15
, Issue.SUPPL. I
-
-
Classen, D.C.1
Metzger, J.2
-
7
-
-
22144474788
-
Adverse drug event surveillance and drug withdrawals in the United States 1969-2002
-
Jun 27
-
Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002. Arch Intern Med 2005 Jun 27; 165 (12): 1363-1369
-
(2005)
Arch Intern Med
, vol.165
, Issue.12
, pp. 1363-1369
-
-
Wysowski, D.K.1
Swartz, L.2
-
8
-
-
33750338501
-
-
Committee on the Assessment of the US Drug Safety Sys-tem Washington DC: National Academies Press
-
Committee on the Assessment of the US Drug Safety Sys-tem. The future of drug safety: promoting and protecting the health of the public. Washington, DC: National Academies Press, 2006 9.
-
(2006)
The Future of Drug Safety: Promoting and Protecting the Health of the Public
, pp. 9
-
-
-
9
-
-
23044447801
-
Opening pandora?s pillbox: Using modern information tools to improve drug safety
-
Jul/Aug
-
Gottlieb S. Opening pandora?s pillbox: using modern information tools to improve drug safety. Health Aff 2005 Jul/Aug; 24 (4): 938-949
-
(2005)
Health Aff
, vol.24
, Issue.4
, pp. 938-949
-
-
Gottlieb, S.1
-
10
-
-
0029384423
-
The incident reporting system does not detect adverse drug events: A problem for quality improvement
-
Oct
-
Cullen D, Bates D, Small S, et al. The incident reporting system does not detect adverse drug events: a problem for quality improvement. Jt Comm J Qual Improv 1995 Oct; 21 (10): 549-552
-
(1995)
Jt Comm J Qual Improv
, vol.21
, Issue.10
, pp. 549-552
-
-
Cullen, D.1
Bates, D.2
Small, S.3
-
11
-
-
0031970658
-
Pharmacovigilance in the pharma-ceutical industry
-
Talbot JCC, Nilsson BS. Pharmacovigilance in the pharma-ceutical industry. Br J Clin Pharmacol 1998; 45: 427-431
-
(1998)
Br J Clin Pharmacol
, vol.45
, pp. 427-431
-
-
Talbot, J.C.C.1
Nilsson, B.S.2
-
12
-
-
33646744337
-
Under-reporting of adverse drug reactions: A systematic review
-
Hazell L, Shakir SAW. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006; 29 (5): 385-396
-
(2006)
Drug Saf
, vol.29
, Issue.5
, pp. 385-396
-
-
Hazell, L.1
Shakir, S.A.W.2
-
13
-
-
0033518849
-
Postmarketing surveillance and ad-verse drug reactions: Current perspectives and future needs
-
Mar 3
-
Brewer T, Colditz GA. Postmarketing surveillance and ad-verse drug reactions: current perspectives and future needs. JAMA 1999 Mar 3; 281 (9): 824-834
-
(1999)
JAMA
, vol.281
, Issue.9
, pp. 824-834
-
-
Brewer, T.1
Colditz, G.A.2
-
14
-
-
41449104685
-
Drug-review deadlines and safety problems
-
Mar 27
-
Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems. N Engl J Med 2008 Mar 27; 358 (13): 1354-1361
-
(2008)
N Engl J Med
, vol.358
, Issue.13
, pp. 1354-1361
-
-
Carpenter, D.1
Zucker, E.J.2
Avorn, J.3
-
15
-
-
20444389780
-
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. 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 2005; 61 (5): 881-892
-
(2005)
Soc Sci Med
, vol.61
, Issue.5
, pp. 881-892
-
-
Abraham, J.1
Davis, C.2
-
17
-
-
29544437699
-
"Black box" 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk
-
Murphy S, Roberts R. "Black box" 101: how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. J Allergy Clin Immunol 2006; 117: 34-39
-
(2006)
J Allergy Clin Immunol
, vol.117
, pp. 34-39
-
-
Murphy, S.1
Roberts, R.2
-
18
-
-
33745092018
-
The gray areas of black box warnings: Who is responsible for heeding them?
-
Jun
-
Karch AM. The gray areas of black box warnings: who is responsible for heeding them? Am J Nurs 2006 Jun; 106 (6): 77-78
-
(2006)
Am J Nurs
, vol.106
, Issue.6
, pp. 77-78
-
-
Karch, A.M.1
-
19
-
-
0036570099
-
Timing of new black box warnings and withdrawals for prescription medications
-
May 1
-
Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002 May 1; 287 (17): 2215-2220
-
(2002)
JAMA
, vol.287
, Issue.17
, pp. 2215-2220
-
-
Lasser, K.E.1
Allen, P.D.2
Woolhandler, S.J.3
-
20
-
-
33845346759
-
What is the best approach to reducing birth defects associated with isotretinoin?
-
Nov
-
Abroms L, Maibach E, Lyon-Daniel K, et al. What is the best approach to reducing birth defects associated with isotretinoin? PLoS Med 2006 Nov; 3 (11): 1978-1983
-
(2006)
PLoS Med
, vol.3
, Issue.11
, pp. 1978-1983
-
-
Abroms, L.1
Maibach, E.2
Lyon-Daniel, K.3
Al, E.4
-
21
-
-
33847744224
-
The cost of clear skin: Balancing the social and safety costs of iPLEDGE with the efficacy of accutane (isotretinoin)
-
Doshi AE. The cost of clear skin: balancing the social and safety costs of iPLEDGE with the efficacy of accutane (isotretinoin). Seton Hall Law Rev 2007; 37: 625-660
-
(2007)
Seton Hall Law Rev
, vol.37
, pp. 625-660
-
-
Doshi, A.E.1
-
22
-
-
70349954559
-
-
Roche Pharmaceuticals press release; online Accessed 2009 Sep 4
-
Roche Pharmaceuticals. Roche discontinues and plans to delist accutane in the US [press release; online]. Available from URL: http://www.rocheusa.com/ newsroom/current/2009/pr2009062601.html [Accessed 2009 Sep 4]
-
Roche Discontinues and Plans to Delist Accutane in the US
-
-
-
23
-
-
33845914592
-
Contraindication labelling changes in the United States and Germany
-
Garbe E, Andersohn F. Contraindication labelling changes in the United States and Germany. Eur J Clin Pharmacol 2007; 63 (1): 87-93
-
(2007)
Eur J Clin Pharmacol
, vol.63
, Issue.1
, pp. 87-93
-
-
Garbe, E.1
Andersohn, F.2
-
24
-
-
34247189637
-
Decisions by regulatory agencies: Are they evidence-based?
-
Apr 11 Accessed 2009 Sep 4
-
Furberg CD. Decisions by regulatory agencies: are they evidence-based? Trials 2007 Apr 11; 8 (1): 13 [online]. Available from URL: http://www. trialsjournal.com/content/ pdf/1745-6215-8-13.pdf [Accessed 2009 Sep 4]
-
(2007)
Trials
, vol.8
, Issue.1
, pp. 13
-
-
Furberg, C.D.1
-
25
-
-
10744224971
-
Prescribing information in 26 countries: A comparative study
-
Aug
-
Reggi V, Balocco-Mattavelli R, Bonati M, et al. Prescribing information in 26 countries: a comparative study. Eur J Clin Pharmacol 2003 Aug; 59 (4): 263-270
-
(2003)
Eur J Clin Pharmacol
, vol.59
, Issue.4
, pp. 263-270
-
-
Reggi, V.1
Balocco-Mattavelli, R.2
Bonati, M.3
-
26
-
-
41749092580
-
Provision of information on regulatory authorities? websites
-
Mar 11
-
Vitry A, Lexchin J, Sasich L, et al. Provision of information on regulatory authorities? websites. Intern Med J 2008 Mar 11; 38 (7): 559-567
-
(2008)
Intern Med J
, vol.38
, Issue.7
, pp. 559-567
-
-
Vitry, A.1
Lexchin, J.2
Sasich, L.3
-
27
-
-
1842587809
-
Science, politics, and federal advisory com-mittees
-
Apr 1
-
Steinbrook R. Science, politics, and federal advisory com-mittees. N Engl J Med 2004 Apr 1; 350 (14): 1454-1460
-
(2004)
N Engl J Med
, vol.350
, Issue.14
, pp. 1454-1460
-
-
Steinbrook, R.1
-
28
-
-
17144391455
-
The US Food and Drug Adminis-tration Cardiorenal Advisory Panel and the drug approval process
-
Apr 5
-
Roden DM, Temple R. The US Food and Drug Adminis-tration Cardiorenal Advisory Panel and the drug approval process. Circulation 2005 Apr 5; 111 (13): 1697-1702
-
(2005)
Circulation
, vol.111
, Issue.13
, pp. 1697-1702
-
-
Roden, D.M.1
Temple, R.2
-
29
-
-
4243065621
-
Modernizing the FDA: An incremental revolu-tion
-
Mar/Apr
-
Merrill RA. Modernizing the FDA: an incremental revolu-tion. Health Aff 1999 Mar/Apr; 18 (2): 96-111
-
(1999)
Health Aff
, vol.18
, Issue.2
, pp. 96-111
-
-
Merrill, R.A.1
-
30
-
-
70349950339
-
Role of conflict of interest in public advisory councils
-
Cheney D, editor Frederick (MD): University Publishing Group
-
Shamoo AE. Role of conflict of interest in public advisory councils. In: Cheney D, editor. Ethical issues in research. Frederick (MD): University Publishing Group, 1993; 159-174
-
(1993)
Ethical Issues in Research
, pp. 159-174
-
-
Shamoo, A.E.1
-
31
-
-
33748593352
-
The decision-making process of US Food and Drug Administration advisory committees on switches from prescription to over-the-counter status: A comparative case study
-
Aug
-
Nguyen NT, Cook DM, Bero LA. The decision-making process of US Food and Drug Administration advisory committees on switches from prescription to over-the-counter status: a comparative case study. Clin Ther 2006 Aug; 28 (8): 1231-1243
-
(2006)
Clin Ther
, vol.28
, Issue.8
, pp. 1231-1243
-
-
Nguyen, N.T.1
Cook, D.M.2
Bero, L.A.3
-
35
-
-
70349943589
-
Risks of suicidal ideation and behavior with epi-lepsy drugs reaffirmed
-
Jul 10 [online] Accessed 2009 Mar 31
-
Neale T. Risks of suicidal ideation and behavior with epi-lepsy drugs reaffirmed. MedPage Today 2008 Jul 10 [online]. Available from URL: http://www.medpagetoday. com/Psychiatry/GeneralPsychiatry/10086 [Accessed 2009 Mar 31]
-
(2008)
MedPage Today
-
-
Neale, T.1
-
36
-
-
33847261097
-
Qualitative research designs: Selection and implementation
-
Mar
-
Creswell JW, Hanson WE, Plano VLC, et al. Qualitative research designs: selection and implementation. Counsel Psych 2007 Mar; 35 (2): 236-264
-
(2007)
Counsel Psych
, vol.35
, Issue.2
, pp. 236-264
-
-
Creswell, J.W.1
Hanson, W.E.2
Plano, V.L.C.3
-
37
-
-
0035380172
-
Real qualitative researchers do not count: The use of numbers in qualitative research
-
Jun
-
Sandelowski M. Real qualitative researchers do not count: the use of numbers in qualitative research. Res Nurs Health 2001 Jun; 24 (3): 230-240
-
(2001)
Res Nurs Health
, vol.24
, Issue.3
, pp. 230-240
-
-
Sandelowski, M.1
-
41
-
-
70349950334
-
-
Food and Drug Administration Center for Drug Evaluation and Research. Pulmonary-Allergy Drugs Advisory Committee July 13 [online] Accessed 2009 Mar 31
-
Food and Drug Administration Center for Drug Evalua-tion and Research. Psychopharmacologic Drugs Advisory Committee 2005 December 2 [online]. Available from URL http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4195T1.pdf [Accessed 2009 Mar 31].
-
(2005)
-
-
-
42
-
-
70349951930
-
-
Food and Drug Administration Center for Drug Evalua-tion and Research. Peripheral and Central Nervous System Drugs Advisory Committee May 17 [online] Accessed 2009 Mar 31
-
Food and Drug Administration Center for Drug Evalua-tion and Research. Peripheral and Central Nervous System Drugs Advisory Committee 2006 May 17 [online]. Available from URL http://www.fda.gov/ohrms/dockets/ac/ 06/transcripts/2006-4216t1-transcript.pdf [Accessed 2009 Mar 31].
-
(2006)
-
-
-
43
-
-
70349957782
-
-
Food and Drug Administration Center for Drug Evalua-tion and Research. Psychopharmacologic Drugs Advisory Committee March 23 [online] Accessed 2009 Mar 31
-
Food and Drug Administration Center for Drug Evalua-tion and Research. Psychopharmacologic Drugs Advisory Committee 2006 March 23 [online]. Available from URL http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4212T1.pdf [Accessed 2009 Mar 31].
-
(2006)
-
-
-
44
-
-
23844457546
-
Perceived risk and citizen pre-ferences for governmental management of routine hazards
-
Gerber BJ, Neeley GW. Perceived risk and citizen pre-ferences for governmental management of routine hazards. Policy Stud J 2005; 33 (3): 395-418
-
(2005)
Policy Stud J
, vol.33
, Issue.3
, pp. 395-418
-
-
Gerber, B.J.1
Neeley, G.W.2
-
46
-
-
33845599054
-
A call for international har-monization in therapeutic risk management
-
Hirst C, Cook S, Dai W, et al. A call for international har-monization in therapeutic risk management. Pharmaco-epidemiol Drug Saf 2006; 15 (12): 839-849
-
(2006)
Pharmaco-epidemiol Drug Saf
, vol.15
, Issue.12
, pp. 839-849
-
-
Hirst, C.1
Cook, S.2
Dai, W.3
-
47
-
-
0345865337
-
Risk manage-ment frameworks for human health and environmental risks
-
Jardine CG, Hrudey SE, Shortreed JH, et al. Risk manage-ment frameworks for human health and environmental risks. J Toxicol Environ Health B 2003; 6 (6): 569-718
-
(2003)
J Toxicol Environ Health B
, vol.6
, Issue.6
, pp. 569-718
-
-
Jardine, C.G.1
Hrudey, S.E.2
Shortreed, J.H.3
-
50
-
-
4644278486
-
The role of scientific evidence of risks and benefits in determining risk management policies for medications
-
Andrews E, Dombeck M. The role of scientific evidence of risks and benefits in determining risk management policies for medications. Pharmacoepidemiol Drug Saf 2004; 13: 599-608
-
(2004)
Pharmacoepidemiol Drug Saf
, vol.13
, pp. 599-608
-
-
Andrews, E.1
Dombeck, M.2
-
52
-
-
22344435549
-
The precautionary principle and pharmaceutical risk management
-
Callreus T. The precautionary principle and pharmaceutical risk management. Drug Saf 2005; 28 (6): 465-471
-
(2005)
Drug Saf
, vol.28
, Issue.6
, pp. 465-471
-
-
Callreus, T.1
-
53
-
-
32644436054
-
Adherence to black box warnings for prescription medications in outpatients
-
Feb 13
-
Lasser KE, Seger DL, Yu DT, et al. Adherence to black box warnings for prescription medications in outpatients. Arch Intern Med 2006 Feb 13; 166 (3): 338-344
-
(2006)
Arch Intern Med
, vol.166
, Issue.3
, pp. 338-344
-
-
Lasser, K.E.1
Seger, D.L.2
Yu, D.T.3
-
54
-
-
33745782075
-
FDA drug pre-scribing warnings: Is the black box half empty or half full?
-
Wagner AK, Chan KA, Dashevsky I, et al. FDA drug pre-scribing warnings: is the black box half empty or half full? Pharmacoepidemiol Drug Saf 2006; 15 (6): 369-386
-
(2006)
Pharmacoepidemiol Drug Saf
, vol.15
, Issue.6
, pp. 369-386
-
-
Wagner, A.K.1
Chan, K.A.2
Dashevsky, I.3
Al, E.4
-
55
-
-
29544432432
-
The "black box" warning and allergy drugs
-
Jan
-
Aaronson DW. The "black box" warning and allergy drugs. J Allergy Clin Immunol 2006 Jan; 117 (1): 40-44
-
(2006)
J Allergy Clin Immunol
, vol.117
, Issue.1
, pp. 40-44
-
-
Aaronson, D.W.1
-
56
-
-
41649086195
-
Regulating off-label drug use: Rethinking the role of the FDA
-
Apr 3
-
Stafford RS. Regulating off-label drug use: rethinking the role of the FDA. N Engl J Med 2008 Apr 3; 358 (14): 1427-1429
-
(2008)
N Engl J Med
, vol.358
, Issue.14
, pp. 1427-1429
-
-
Stafford, R.S.1
-
57
-
-
42449113803
-
FDA guidance on off-label promotion and the state of the literature from sponsors
-
Apr 23
-
Psaty BM, Ray W. FDA guidance on off-label promotion and the state of the literature from sponsors. JAMA 2008 Apr 23; 299 (16): 1949-1951
-
(2008)
JAMA
, vol.299
, Issue.16
, pp. 1949-1951
-
-
Psaty, B.M.1
Ray, W.2
-
58
-
-
33847106466
-
Experts weigh in on promotion, prescription of off-label drugs
-
Feb 21
-
Hampton T. Experts weigh in on promotion, prescription of off-label drugs. JAMA 2007 Feb 21; 297 (7): 683-684
-
(2007)
JAMA
, vol.297
, Issue.7
, pp. 683-684
-
-
Hampton, T.1
-
59
-
-
38049169579
-
Effects of Food and Drug Administration warnings on antidepressant use in a national sample
-
Jan
-
Olfson M, Marcus SC, Druss BG. Effects of Food and Drug Administration warnings on antidepressant use in a national sample. Arch Gen Psychiatry 2008 Jan; 65 (1): 94-101
-
(2008)
Arch Gen Psychiatry
, vol.65
, Issue.1
, pp. 94-101
-
-
Olfson, M.1
Marcus, S.C.2
Druss, B.G.3
-
60
-
-
70349951924
-
-
Food and Drug Administration. Prescription drug advertis-ing (21CFR202.1). US Government Printing Office Accessed 2009 Sep 4
-
Food and Drug Administration. Prescription drug advertis-ing (21CFR202.1). US Government Printing Office 2008 [online]. Available from URL http://edocket.access.gpo.gov/cfr-2001/aprqtr/pdf/21cfr202.1.pdf [Accessed 2009 Sep 4]
-
(2008)
-
-
-
61
-
-
54949095073
-
Risk evaluation and mitigation strategies for drugs with abuse liability: Public interest, special interest, conflicts of interest, and the industry perspective
-
Oct
-
Wright C, Schnoll S, Bernstein D. Risk evaluation and mitigation strategies for drugs with abuse liability: public interest, special interest, conflicts of interest, and the industry perspective. Ann N Y Acad Sci 2008 Oct; 1141: 284-303
-
(2008)
Ann N y Acad Sci
, vol.1141
, pp. 284-303
-
-
Wright, C.1
Schnoll, S.2
Bernstein, D.3
-
62
-
-
43549125769
-
Hospital inspectors eye black-box warn-ings
-
May 15
-
Thompson CA. Hospital inspectors eye black-box warn-ings. Am J Health Syst Pharm 2008 May 15; 65 (10): 890-894
-
(2008)
Am J Health Syst Pharm
, vol.65
, Issue.10
, pp. 890-894
-
-
Thompson, C.A.1
-
63
-
-
0036913265
-
The impact of wording in "Dear doctor" letters and in black box labels
-
Dec
-
Weatherby LB, Nordstrom BL, Fife D, et al. The impact of wording in "Dear doctor" letters and in black box labels. Clin Pharmacol Ther 2002 Dec; 72 (6): 735-742
-
(2002)
Clin Pharmacol Ther
, vol.72
, Issue.6
, pp. 735-742
-
-
Weatherby, L.B.1
Nordstrom, B.L.2
Fife, D.3
-
64
-
-
34248594709
-
Patient receipt and understanding of written information provided with isotretinoin and estrogen prescriptions
-
Jan
-
Allen LaPointe NM, Pappas P, Deverka P, et al. Patient receipt and understanding of written information provided with isotretinoin and estrogen prescriptions. J Gen Intern Med 2007 Jan; 22 (1): 98-101
-
(2007)
J Gen Intern Med
, vol.22
, Issue.1
, pp. 98-101
-
-
Allen Lapointe, N.M.1
Pappas, P.2
Deverka, P.3
-
65
-
-
34548657564
-
The variability and quality of medication container labels
-
Sep 10
-
Shrank WH, Agney-Blais J, Choudhry NK, et al. The variability and quality of medication container labels. Arch Intern Med 2007 Sep 10; 167 (16): 1760-1765
-
(2007)
Arch Intern Med
, vol.167
, Issue.16
, pp. 1760-1765
-
-
Shrank, W.H.1
Agney-Blais, J.2
Choudhry, N.K.3
-
66
-
-
70349946863
-
-
Agency for Healthcare Research and Quality Accessed 2009 Aug 27
-
Agency for Healthcare Research and Quality. CERTs annual report: year 4 2003 [online]. Available from URL http://www.ahrq.gov/clinic/certsrep4.pdf. [Accessed 2009 Aug 27].
-
(2003)
CERTs Annual Report: Year 4
-
-
-
67
-
-
27544485215
-
-
US FDA Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Rockville (MD): US DHHS. Food and Drug Administration
-
US FDA, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Guidance for industry: development and use of risk minimization action plans. Rockville (MD): US DHHS, Food and Drug Administration, 2005
-
(2005)
Guidance for Industry: Development and Use of Risk Minimization Action Plans
-
-
-
68
-
-
33846827526
-
FDA plans new board to monitor drug safety
-
Feb 16 Accessed 2009 Aug 7
-
Kaufman M. FDA plans new board to monitor drug safety. The Washington Post 2005 Feb 16 [online]. Available from URL: http://www.washingtonpost.com/wp- dyn/articles/A25893-2005Feb15.html [Accessed 2009 Aug 7]
-
(2005)
The Washington Post
-
-
Kaufman, M.1
-
69
-
-
12544250078
-
The art and science of risk management: A US research-based industry perspective
-
Bush JK, Dai WS, Dieck GS, et al. The art and science of risk management: a US research-based industry perspective. Drug Saf 2005; 28 (1): 1-18
-
(2005)
Drug Saf
, vol.28
, Issue.1
, pp. 1-18
-
-
Bush, J.K.1
Dai, W.S.2
Dieck, G.S.3
-
70
-
-
36549038142
-
Bolstering the FDA?s drug-safety authority
-
Nov 29
-
Schultz WB. Bolstering the FDA?s drug-safety authority. N Engl J Med 2007 Nov 29; 357 (22): 2217-2219
-
(2007)
N Engl J Med
, vol.357
, Issue.22
, pp. 2217-2219
-
-
Schultz, W.B.1
-
71
-
-
36448966396
-
Law gives FDA new enforcement clout
-
Nov 15
-
Traynor K. Law gives FDA new enforcement clout. Am J Health Syst Pharm 2007 Nov 15; 64 (22): 2314-2315
-
(2007)
Am J Health Syst Pharm
, vol.64
, Issue.22
, pp. 2314-2315
-
-
Traynor, K.1
-
72
-
-
65549113312
-
Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act 2007
-
Department of Health and Human Services Mar 27
-
Department of Health and Human Services. Identification of drug and biological products deemed to have risk evaluation and mitigation strategies for purposes of the Food and Drug Administration Amendments Act 2007. Fed Regist 2008 Mar 27; 73 (60) 16313-16314.
-
(2008)
Fed Regist
, vol.73
, Issue.60
, pp. 16313-16314
-
-
-
73
-
-
55249087229
-
Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices
-
Department of Health and Human Services
-
Department of Health and Human Services. Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Fed Regist 2008; 73 (164): 49603-49610
-
(2008)
Fed Regist
, vol.73
, Issue.164
, pp. 49603-49610
-
-
-
74
-
-
70349967488
-
Rectification without assuming responsibility: Testing the transgression flowchart with the Vioxx recall
-
Vlad I, Sallot LM, Reber BH. Rectification without assuming responsibility: testing the transgression flowchart with the Vioxx recall. J Public Relat Res 2006; 18 (4): 357-379
-
(2006)
J Public Relat Res
, vol.18
, Issue.4
, pp. 357-379
-
-
Vlad, I.1
Sallot, L.M.2
Reber, B.H.3
-
75
-
-
0037220149
-
The science and politics of medicines control
-
Abraham J. The science and politics of medicines control. Drug Saf 2003; 26 (3): 135-143
-
(2003)
Drug Saf
, vol.26
, Issue.3
, pp. 135-143
-
-
Abraham, J.1
-
76
-
-
38849130659
-
-
Subcommittee on Science and Technology of the FDA Science Board November Accessed 2007 Dec 4
-
Subcommittee on Science and Technology of the FDA Science Board. FDA science and mission at risk 2007 November [online]. Available from URL http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b-02-01- FDA%20Report%20on%20Science%20and%20Technology.pdf [Accessed 2007 Dec 4].
-
(2007)
FDA Science and Mission at Risk
-
-
-
77
-
-
0042665807
-
Vulnerability and risk: Some thoughts from a political and policy perspective
-
Sarewitz D, Pielke Jr R, Keykhah M. Vulnerability and risk: some thoughts from a political and policy perspective. Risk Anal 2003; 23 (4): 805-810
-
(2003)
Risk Anal
, vol.23
, Issue.4
, pp. 805-810
-
-
Sarewitz, D.1
Pielke Jr, R.2
Keykhah, M.3
|