-
1
-
-
65949101284
-
Guidance for industry on good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices: Availability
-
Food and Drug Administration
-
Food and Drug Administration. Guidance for industry on good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices: availability. Fed Regist 2009;74(8):1694-1695
-
(2009)
Fed Regist
, vol.74
, Issue.8
, pp. 1694-1695
-
-
-
2
-
-
77956406697
-
-
Office of the Commissioner, Office of Policy. Silver Spring, MD: Food and Drug Administration, January Accessed March 20, 2009, at
-
Office of the Commissioner, Office of Policy. Guidance for industry: good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices. Silver Spring, MD: Food and Drug Administration, January 2009. (Accessed March 20, 2009, at http://www.fda.gov/ OHRMS/DOCKETS/98fr/FDA-2008-D-0053-gdl.pdf.)
-
(2009)
Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
-
-
-
4
-
-
33747495601
-
Off-label and unlicensed prescribing for newborns and children in different settings: A review of the literature and a consideration about drug safety
-
DOI 10.1517/14740338.5.5.703
-
Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf 2006;5:703-718 (Pubitemid 44322888)
-
(2006)
Expert Opinion on Drug Safety
, vol.5
, Issue.5
, pp. 703-718
-
-
Cuzzolin, L.1
Atzei, A.2
Fanos, V.3
-
6
-
-
29344449704
-
Violations of exhibiting and FDA rules at an American Psychiatric Association Annual Meeting
-
DOI 10.1057/palgrave.jphp.3200049
-
Lurie P, Tran T, Wolfe SM, Goodman R. Violations of exhibiting and FDA rules at an American Psychiatric Association annual meeting. J Public Health Policy 2005;26:389-399 (Pubitemid 43003341)
-
(2005)
Journal of Public Health Policy
, vol.26
, Issue.4
, pp. 389-399
-
-
Lurie, P.1
Tran, T.2
Wolfe, S.M.3
Goodman, R.4
-
7
-
-
65949086849
-
The regulation of prescription drug promotion
-
Santoro MA, Gorrie TM, eds. New York: Cambridge University Press
-
Abrams T. The regulation of prescription drug promotion. In: Santoro MA, Gorrie TM, eds. Ethics and the pharmaceutical industry. New York: Cambridge University Press, 2005:153-168
-
(2005)
Ethics and the Pharmaceutical Industry
, pp. 153-168
-
-
Abrams, T.1
-
8
-
-
84926955400
-
Off-label communications and prescription drugs
-
Santoro MA, Gorrie TM, eds. New York: Cambridge University Press
-
Danzis SD. Off-label communications and prescription drugs. In: Santoro MA, Gorrie TM, eds. Ethics and the pharmaceutical industry. New York: Cambridge University Press, 2005:184-195
-
(2005)
Ethics and the Pharmaceutical Industry
, pp. 184-195
-
-
Danzis, S.D.1
-
9
-
-
85031363550
-
-
Federal Food, Drugs, and Cosmetics Act, 21 U.S.C. 355(a) (2008)
-
Federal Food, Drugs, and Cosmetics Act, 21 U.S.C. 355(a) (2008).
-
-
-
-
10
-
-
85031364681
-
-
Definitions and interpretations, 21 C.F.R. § 310.3(h) (2008)
-
Definitions and interpretations, 21 C.F.R. § 310.3(h) (2008).
-
-
-
-
11
-
-
85031365768
-
-
Prescription-drug advertisements, 21 C.F.R. § 202.1(e)(4) (2008)
-
Prescription-drug advertisements, 21 C.F.R. § 202.1(e)(4) (2008).
-
-
-
-
12
-
-
85031352972
-
-
Federal Food, Drugs, and Cosmetics Act, 21 U.S.C. 331 (2008)
-
Federal Food, Drugs, and Cosmetics Act, 21 U.S.C. 331 (2008).
-
-
-
-
13
-
-
85031364317
-
-
Washington Legal Foundation v. Henney, 202 F.3d 331 (D.C. Cir. 2000)
-
Washington Legal Foundation v. Henney, 202 F.3d 331 (D.C. Cir. 2000).
-
-
-
-
14
-
-
85031365044
-
-
Kordel v. United States, 335 U.S. 345 (1948)
-
Kordel v. United States, 335 U.S. 345 (1948).
-
-
-
-
15
-
-
85031357759
-
-
Prescription-drug advertisements, 21 C.F.R. § 202.1(l)(2) (2008)
-
Prescription-drug advertisements, 21 C.F.R. § 202.1(l)(2) (2008).
-
-
-
-
16
-
-
0343077169
-
Citizen petition regarding the Food and Drug Administration's policy on promotion of unapproved uses of approved drugs and devices; request for comments
-
Food and Drug Administration
-
Food and Drug Administration. Citizen petition regarding the Food and Drug Administration's policy on promotion of unapproved uses of approved drugs and devices; request for comments. Fed Regist 1994;59(222):59820-59826
-
(1994)
Fed Regist
, vol.59
, Issue.222
, pp. 59820-59826
-
-
-
18
-
-
85031361445
-
-
Washington Legal Foundation v. Friedman, 36 F. Supp. 2d 16 (D.D.C. 1999)
-
Washington Legal Foundation v. Friedman, 36 F. Supp. 2d 16 (D.D.C. 1999).
-
-
-
-
19
-
-
0027128055
-
Draft policy statement on industry-supported scientific and educational activities: Notice
-
Food and Drug Administration
-
Food and Drug Administration. Draft policy statement on industry-supported scientific and educational activities: notice. Fed Regist 1992;57(229):56412-56414
-
(1992)
Fed Regist
, vol.57
, Issue.229
, pp. 56412-56414
-
-
-
20
-
-
0345661710
-
Advertising and promotion; guidances
-
Idem
-
Idem. Advertising and promotion; guidances. Fed Regist 1996;61(196):52800-52801
-
(1996)
Fed Regist
, vol.61
, Issue.196
, pp. 52800-52801
-
-
-
21
-
-
0007105944
-
Final guidance on industry-supported scientific and educational activities
-
Idem
-
Idem. Final guidance on industry-supported scientific and educational activities. Fed Regist 1997;62(232):64073.
-
(1997)
Fed Regist
, vol.62
, Issue.232
, pp. 64073
-
-
-
22
-
-
0032553158
-
Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices: Final rule
-
Idem
-
Idem. Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices: final rule. Fed Regist 1998;63(224):64556-64588
-
(1998)
Fed Regist
, vol.63
, Issue.224
, pp. 64556-64588
-
-
-
23
-
-
85031356324
-
-
Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices, 21 C.F.R. § 99 (2008)
-
Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices, 21 C.F.R. § 99 (2008).
-
-
-
-
24
-
-
42249097132
-
Pharmaceutical promotion to physicians and First Amendment rights
-
Kesselheim AS, Avorn J. Pharmaceutical promotion to physicians and First Amendment rights. N Engl J Med 2008;358:1727-1732
-
(2008)
N Engl J Med
, vol.358
, pp. 1727-1732
-
-
Kesselheim, A.S.1
Avorn, J.2
-
25
-
-
85031352257
-
-
Thompson v. Western States Medical Center, 535 U.S. 357 (2002)
-
Thompson v. Western States Medical Center, 535 U.S. 357 (2002).
-
-
-
-
26
-
-
85031361078
-
-
Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998)
-
Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998).
-
-
-
-
27
-
-
85031368145
-
-
United States v. Caputo, 288 F Supp 2d 912 (N.D. Ill. 2003)
-
United States v. Caputo, 288 F Supp 2d 912 (N.D. Ill. 2003).
-
-
-
-
28
-
-
85031350795
-
Off-label use of drugs gets a push - Big Pharma lobbies Washington to relax rules on marketing
-
April 18
-
Mundy A. Off-label use of drugs gets a push - Big Pharma lobbies Washington to relax rules on marketing. Wall Street Journal. April 18, 2008:A14.
-
(2008)
Wall Street Journal
-
-
Mundy, A.1
-
29
-
-
85031352660
-
FDA issues draft guidance for dissemination of off-label reprints
-
April 4, Available at
-
Markus CM, Bragg JL, Tseng EH, Lorell BH. FDA issues draft guidance for dissemination of off-label reprints. Health Lawyers Weekly. April 4, 2008. (Available at http://www.healthlawyers.org.)
-
(2008)
Health Lawyers Weekly
-
-
Markus, C.M.1
Bragg, J.L.2
Tseng, E.H.3
Lorell, B.H.4
-
30
-
-
65949120241
-
Setback for effort to ease rules on promoting drugs
-
April 19
-
Saul S. Setback for effort to ease rules on promoting drugs. New York Times. April 19, 2008:B3.
-
(2008)
New York Times
-
-
Saul, S.1
-
31
-
-
42249098105
-
Guest authorship and ghostwriting in publications related to rofecoxib: A case study of industry documents from rofecoxib litigation
-
Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 2008;299:1800-1812
-
(2008)
JAMA
, vol.299
, pp. 1800-1812
-
-
Ross, J.S.1
Hill, K.P.2
Egilman, D.S.3
Krumholz, H.M.4
-
33
-
-
40349092788
-
Critical lessons from the ENHANCE trial
-
Greenland P, Lloyd-Jones D. Critical lessons from the ENHANCE trial. JAMA 2008;299:953-955
-
(2008)
JAMA
, vol.299
, pp. 953-955
-
-
Greenland, P.1
Lloyd-Jones, D.2
-
34
-
-
48249100463
-
Pharmaceutical promotion and First Amendment rights
-
Kesselheim AS, Avorn J. Pharmaceutical promotion and First Amendment rights. N Engl J Med 2008;359:536-537
-
(2008)
N Engl J Med
, vol.359
, pp. 536-537
-
-
Kesselheim, A.S.1
Avorn, J.2
-
35
-
-
85031348704
-
-
LexisNexis home page. Accessed March 20, 2009, at
-
LexisNexis home page. (Accessed March 20, 2009, at http://www.lexis.com.)
-
-
-
-
46
-
-
85031365166
-
-
False Claims Act, 31 U.S.C. § 3729 (2008)
-
False Claims Act, 31 U.S.C. § 3729 (2008).
-
-
-
-
47
-
-
65949084750
-
Protecting public health from outside the physician's office: A century of FDA regulation from drug safety labeling to off-label drug promotion
-
Helm KA. Protecting public health from outside the physician's office: a century of FDA regulation from drug safety labeling to off-label drug promotion. Fordham Intellect Prop Media Entertainment Law J 2007;18:117-187
-
(2007)
Fordham Intellect Prop Media Entertainment Law J
, vol.18
, pp. 117-187
-
-
Helm, K.A.1
-
48
-
-
65949086848
-
Cell Therapeutics to pay $10.5 million to settle feds' suit
-
April 18
-
Orsini-Meinhard K. Cell Therapeutics to pay $10.5 million to settle feds' suit. Seattle Times. April 18, 2007:D1.
-
(2007)
Seattle Times
-
-
Orsini-Meinhard, K.1
-
49
-
-
33750944038
-
Indictment of doctor tests drug marketing rules
-
July 22
-
Berenson A. Indictment of doctor tests drug marketing rules. New York Times. July 22, 2006.
-
(2006)
New York Times
-
-
Berenson, A.1
-
50
-
-
85031365164
-
-
United States ex rel. Franklin v. Parke-Davis, 2003 U.S. Dist. LEXIS 15754 (D. Mass. 2003)
-
United States ex rel. Franklin v. Parke-Davis, 2003 U.S. Dist. LEXIS 15754 (D. Mass. 2003).
-
-
-
-
51
-
-
51049118128
-
Whistleblower-initiated enforcement actions against health care fraud and abuse in the United States, 1996 to 2005
-
Kesselheim AS, Studdert DM. Whistleblower-initiated enforcement actions against health care fraud and abuse in the United States, 1996 to 2005. Ann Intern Med 2008;149:342-349
-
(2008)
Ann Intern Med
, vol.149
, pp. 342-349
-
-
Kesselheim, A.S.1
Studdert, D.M.2
-
52
-
-
33748929666
-
Pros and cons of off-label promotion investigations and prosecutions
-
Loucks MK. Pros and cons of off-label promotion investigations and prosecutions. Food Drug Law J 2006;61:577-583
-
(2006)
Food Drug Law J
, vol.61
, pp. 577-583
-
-
Loucks, M.K.1
-
53
-
-
85031350028
-
Draft version of FDA guide on journal dissemination sparks debate
-
Arlington, VA: Inside Washington
-
Draft version of FDA guide on journal dissemination sparks debate. Vol.13. FDA Week. 2007. (Arlington, VA: Inside Washington.)
-
(2007)
FDA Week
, vol.13
-
-
-
54
-
-
42449113803
-
FDA guidance on off-label promotion and the state of the literature from sponsors
-
Psaty BM, Ray W. FDA guidance on off-label promotion and the state of the literature from sponsors. JAMA 2008;299:1949-1951.
-
(2008)
JAMA
, vol.299
, pp. 1949-1951
-
-
Psaty, B.M.1
Ray, W.2
-
55
-
-
41649086195
-
Regulating off-label drug use - Rethinking the role of the FDA
-
Stafford RS. Regulating off-label drug use - rethinking the role of the FDA. N Engl J Med 2008;358:1427-1429
-
(2008)
N Engl J Med
, vol.358
, pp. 1427-1429
-
-
Stafford, R.S.1
-
57
-
-
50949128432
-
Industry-sponsored clinical research: A broken system
-
Angell M. Industry-sponsored clinical research: a broken system. JAMA 2008;300:1069-1071
-
(2008)
JAMA
, vol.300
, pp. 1069-1071
-
-
Angell, M.1
|