-
2
-
-
52649158730
-
An integrated approach to oversight assessment for emerging technologies
-
J. Kuzma et al., "An Integrated Approach to Oversight Assessment for Emerging Technologies Risk Analysis 28, no. 5 (2008 1197 1220.
-
(2008)
Risk Analysis
, vol.28
, Issue.5
, pp. 1197-1220
-
-
Kuzma, J.1
-
3
-
-
76149098834
-
Generic expert elicitation survey instrument, Appendix A in, Developing U.S. oversight strategies for nanobiotechnology: Learning from past oversight experiences
-
"Generic Expert Elicitation Survey Instrument," Appendix A in J. Paradise et al., "Developing U.S. Oversight Strategies for Nanobiotechnology: Learning from Past Oversight Experiences Journal of Law, Medicine & Ethics 37, no. 4 (2009 688 705.
-
(2009)
Journal of Law, Medicine & Ethics
, vol.37
, Issue.4
, pp. 688-705
-
-
Paradise, J.1
-
4
-
-
76149128127
-
-
Id.
-
Id.
-
-
-
-
5
-
-
1842573485
-
U.S. food and drug law and FDA: A historical background
-
in. K.R. Piña. and. W. L. Pines. eds. Washington, D.C. Food and Drug Law Institute. at 17.
-
P. Hyman, "U.S. Food and Drug Law and FDA: A Historical Background in K.R. Piña and W. L. Pines, eds., A Practical Guide to Food and Drug Law and Regulation: Second Edition (Washington, D.C. : Food and Drug Law Institute, 2002 at 17.
-
(2002)
A Practical Guide to Food and Drug Law and Regulation: Second Edition
-
-
Hyman, P.1
-
6
-
-
84868162726
-
-
The Food and Drug Administration (FDA) Office of the Commissioner oversees the actions of all the individual product-specific FDA Centers. . available at. last visited August 20, 2008).
-
The Food and Drug Administration (FDA) Office of the Commissioner oversees the actions of all the individual product-specific FDA Centers. See Organization Chart of FDA, available at http://www.fda.gov/oc/orgcharts/fda.pdf last visited August 20, 2008).
-
See Organization Chart of FDA
-
-
-
7
-
-
84868187414
-
-
The Federal Food, Drug and Cosmetic Act (FDCA) is codified both in 21 U.S.C. § 301 et seq. and as FDCA §1 et seq. Throughout this article, we will use the U.S. Code (U.S.C.) sections.
-
The Federal Food, Drug and Cosmetic Act (FDCA) is codified both in 21 U.S.C. § 301 et seq. and as FDCA §1 et seq. Throughout this article, we will use the U.S. Code (U.S.C.) sections.
-
-
-
-
8
-
-
84868187415
-
-
See Department of Health and Human Services (DHHS) Organization Chart, available at. last visited September 15, 2009).
-
See Department of Health and Human Services (DHHS) Organization Chart, available at http://www.hhs.gov/about/orgchart.html last visited September 15, 2009).
-
-
-
-
11
-
-
84881254440
-
-
FDA Mission Statement. available at. last visited September 15, 2009).
-
FDA Mission Statement, "What We Do available at http://www.fda.gov/ opacom/morechoices/mission.html last visited September 15, 2009).
-
"what We Do
-
-
-
12
-
-
0036051813
-
The safety assessment process - Setting the scene: An FDA perspective
-
at S6.
-
L. M. Schechtman, "The Safety Assessment Process - Setting the Scene: An FDA Perspective Institute for Laboratory Animal Research Journal 43, Supplement (2002 S5 S10, at S6.
-
(2002)
Institute for Laboratory Animal Research Journal
, vol.43
, Issue.SUPPL.
-
-
Schechtman, L.M.1
-
13
-
-
84868179669
-
-
21 U.S.C. § 371(a)
-
-21 U.S.C. § 371(a)(2009).
-
(2009)
-
-
-
14
-
-
76149127118
-
-
The scope of this article does not include foods, cosmetics, biologics, and animal drugs.
-
The scope of this article does not include foods, cosmetics, biologics, and animal drugs.
-
-
-
-
15
-
-
84868179667
-
-
This pertains to products except that those "for which a license has been approved under subsection (a) shall not be required to have an approved application under section 505 of such Act (21 U.S.C. 355)." 42 U.S.C. § 262(j)
-
This pertains to products except that those "for which a license has been approved under subsection (a) shall not be required to have an approved application under section 505 of such Act (21 U.S.C. 355)." 42 U.S.C. § 262(j) (2009).
-
(2009)
-
-
-
16
-
-
76149087556
-
-
See FDCA, supra note 7.
-
See FDCA, supra note 7.
-
-
-
-
17
-
-
84868180741
-
-
21 U.S.C. §§ 351-360
-
-21 U.S.C. §§ 351-360 (2009).
-
(2009)
-
-
-
18
-
-
84868179670
-
-
The FDA describes a generic drug product as "one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use." See FDA ANDA Process for Generic Drugs, available at. last visited August 20, 2008).
-
The FDA describes a generic drug product as "one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use." See FDA ANDA Process for Generic Drugs, available at http://www.fda.gov/cder/Regulatory/ applications/ANDA.htm last visited August 20, 2008).
-
-
-
-
19
-
-
84868187413
-
-
See Piña and Pines, supra note 5.
-
See Piña and Pines, supra note 5.
-
-
-
-
20
-
-
84868179664
-
-
21 C.F.R § 58
-
-21 C.F.R § 58 (2009).
-
(2009)
-
-
-
21
-
-
84868179662
-
-
21 U.S.C. § 355(i)
-
-21 U.S.C. § 355(i) (2009).
-
(2009)
-
-
-
22
-
-
84868174852
-
-
21 C.F.R. § 50
-
-21 C.F.R. § 50 (2009).
-
(2009)
-
-
-
23
-
-
84868187407
-
-
21 C.F.R. § 56
-
-21 C.F.R. § 56 (2009).
-
(2009)
-
-
-
24
-
-
84868181383
-
-
21 C.F.R. § 314. See FDA, Good Review Management Principles for PDUFA Products, April 2005, available at. last visited August 20, 2008).
-
-21 C.F.R. § 314 (2009). The FDA provides guidance for the NDA process. See FDA, Good Review Management Principles for PDUFA Products, April 2005, available at http://www.fda.gov/CDER/GUIDANCE/5812fnl.pdf last visited August 20, 2008).
-
(2009)
The FDA Provides Guidance for the NDA Process
-
-
-
25
-
-
0003716539
-
-
For guidance on the meaning of "adequate and well-controlled" studies, see. FDA. available at. last visited August 20, 2008).
-
For guidance on the meaning of "adequate and well-controlled" studies, see FDA, Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products, May 1998, available at http://www.fda.gov/cber/gdlns/clineff.pdf last visited August 20, 2008).
-
(1998)
Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
-
-
-
26
-
-
84868174850
-
-
21 U.S.C. § 355(b)(1)
-
-21 U.S.C. § 355(b)(1) (2009).
-
(2009)
-
-
-
27
-
-
84868179663
-
-
21 C.F.R. § 314.510, Subpart H. A list of NDAs approved under Subpart H can be found on the FDA's website, available at. last visited September 15, 2009).
-
-21 C.F.R. § 314.510, Subpart H (2009). A list of NDAs approved under Subpart H can be found on the FDA's website, available at http://www.fda.gov/Cder/rdmt/accappr.htm last visited September 15, 2009).
-
(2009)
-
-
-
28
-
-
84868179661
-
-
Bioequivalence is defined as "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." 21 C.F.R. § 320.1(e). The bioavailability standard is defined as the "the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action." 21 C.F.R. § 320.1(a) (2009).
-
Bioequivalence is defined as "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." 21 C.F.R. § 320.1(e) (2009). The bioavailability standard is defined as the "the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action." 21 C.F.R. § 320.1(a) (2009).
-
(2009)
-
-
-
29
-
-
84868174849
-
-
21 U.S.C. § 355(j)(2)(A)(i)-(viii). See also 21 C.F.R. § 314.94 (2009).
-
-21 U.S.C. § 355(j)(2)(A)(i)-(viii) (2009). See also 21 C.F.R. § 314.94 (2009).
-
(2009)
-
-
-
30
-
-
84868187405
-
-
21 U.S.C. §§ 351-360
-
-21 U.S.C. §§ 351-360 (2009).
-
(2009)
-
-
-
32
-
-
84868180736
-
-
21 U.S.C. § 360(c)
-
-21 U.S.C. § 360(c) (2009).
-
(2009)
-
-
-
34
-
-
76149119549
-
-
Id.
-
Id.
-
-
-
-
35
-
-
76149143231
-
-
Id.
-
Id.
-
-
-
-
36
-
-
84868187403
-
-
21 C.F.R. §§ 862-892
-
-21 C.F.R. §§ 862-892 (2009).
-
(2009)
-
-
-
37
-
-
84868180737
-
-
21 U.S.C. § 360(c)(i)(1)(A)
-
-21 U.S.C. § 360(c)(i)(1)(A) (2009).
-
(2009)
-
-
-
38
-
-
14644437012
-
Food and drug administration regulation of IVDs
-
and. at 4.
-
E. Mansfield, T. J. O'Leary, and S. I. Gutman, "Food and Drug Administration Regulation of IVDs Journal of Molecular Devices 7, no. 1 (2005 2 7, at 4.
-
(2005)
Journal of Molecular Devices
, vol.7
, Issue.1
, pp. 2-7
-
-
Mansfield, E.1
O'Leary, T.J.2
Gutman, S.I.3
-
39
-
-
84868187399
-
-
21 C.F.R. §§ 862-880
-
-21 C.F.R. §§ 862-880 (2009).
-
(2009)
-
-
-
40
-
-
84868180735
-
-
21 U.S.C. § 360(e)
-
-21 U.S.C. § 360(e) (2009).
-
(2009)
-
-
-
41
-
-
76149089951
-
-
See Wilson and Clarke, supra note 33, at 129.
-
See Wilson and Clarke, supra note 33, at 129.
-
-
-
-
42
-
-
84868187400
-
-
The medical device provisions allow manufacturers to file an Investigational Device Exemption (IDE) to clinically test experimental devices in order to acquire safety and performance data. This is similar to the IND process, except that approval by a local IRB is typically sufficient unless the process of review by the committee is found to be inadequate. 21 U.S.C. § 360(j)(g) (3)(A)(ii)(II). The FDA divides investigational devices into two categories: those posing "significant risk" with requirements similar to new drugs and those that do not pose significant risk where IRB approval and satisfaction of a number of other requirements achieves the IDE status without the rigorous application process. 21 C.F.R. § 812.2(b) (2009).
-
The medical device provisions allow manufacturers to file an Investigational Device Exemption (IDE) to clinically test experimental devices in order to acquire safety and performance data. This is similar to the IND process, except that approval by a local IRB is typically sufficient unless the process of review by the committee is found to be inadequate. 21 U.S.C. § 360(j)(g) (3)(A)(ii)(II) (2009). The FDA divides investigational devices into two categories: those posing "significant risk" with requirements similar to new drugs and those that do not pose significant risk where IRB approval and satisfaction of a number of other requirements achieves the IDE status without the rigorous application process. 21 C.F.R. § 812.2(b) (2009).
-
(2009)
-
-
-
43
-
-
84868174847
-
-
21 U.S.C. § 360e(c) (2009)
-
-21 U.S.C. § 360e(c) (2009).
-
-
-
-
44
-
-
7844242538
-
The limited state of technology assessment for medical devices: Facing the issues
-
Supplement at SP189.
-
S. D. Ramsey et al., "The Limited State of Technology Assessment for Medical Devices: Facing the Issues American Journal of Managed Care 4, Supplement (1998 SP188 SP199, at SP189.
-
(1998)
American Journal of Managed Care
, vol.4
-
-
Ramsey, S.D.1
-
45
-
-
76149094626
-
-
See Mansfield, O'Leary, and Gutman, supra note 38, at 3
-
See Mansfield, O'Leary, and Gutman, supra note 38, at 3.
-
-
-
-
46
-
-
0037448393
-
Ensuring safe & effective medical devices
-
and. at 191.
-
D. W. Feigal, S. N. Gardner, and M. McClellan, "Ensuring Safe & Effective Medical Devices New England Journal of Medicine 348, no. 3 (2003 191 192, at 191.
-
(2003)
New England Journal of Medicine
, vol.348
, Issue.3
, pp. 191-192
-
-
Feigal, D.W.1
Gardner, S.N.2
McClellan, M.3
-
47
-
-
76149092967
-
-
See Ramsey et al., supra note 44
-
See Ramsey et al., supra note 44.
-
-
-
-
48
-
-
30544442644
-
Angstrom medica: Securing FDA approval and commercializing a nanomedical device
-
at 172
-
A. S. Baluch, "Angstrom Medica: Securing FDA Approval and Commercializing a Nanomedical Device Nanotechnology Law & Business 2, no. 2 (2005 168 173, at 172.
-
(2005)
Nanotechnology Law & Business
, vol.2
, Issue.2
, pp. 168-173
-
-
Baluch, A.S.1
-
49
-
-
84868174848
-
-
Pub. L. No. 107-250. See also FDA, "Overview of the Office of Combination Products," available at. last visited September 15, 2009). The Safe Medical Device Act of 1990 originally gave primary jurisdiction to the most relevant center to regulate combination products. Pub. L. No. 101-629 (November 28, 1990), codified at 21 U.S.C. § 353(g) (2009).
-
Pub. L. No. 107-250 (Oct. 26, 2002). See also FDA, "Overview of the Office of Combination Products," available at http://www.fda.gov/oc/ combination/overview.html last visited September 15, 2009). The Safe Medical Device Act of 1990 originally gave primary jurisdiction to the most relevant center to regulate combination products. Pub. L. No. 101-629 (November 28, 1990), codified at 21 U.S.C. § 353(g) (2009).
-
(2002)
-
-
-
50
-
-
76149110219
-
-
at 49848-49862
-
-70 Federal Register 164, at 49848-49862 (August 25, 2005).
-
(2005)
70 Federal Register
, vol.164
-
-
-
52
-
-
0023256904
-
The federal regulation of medical devices
-
See. supra note 44, citing
-
See Ramsey et al., supra note 44, citing D. A. Kessler et al., "The Federal Regulation of Medical Devices," New England Journal of Medicine 317, no. 6 (1987): 357-366.
-
(1987)
New England Journal of Medicine
, vol.317
, Issue.6
, pp. 357-366
-
-
Ramsey1
Kessler, D.A.2
-
53
-
-
0038143185
-
Nanotechnology: Convergence with modern biology and medicine
-
at 337
-
M. C. Roco, "Nanotechnology: Convergence with Modern Biology and Medicine Current Opinion in Biotechnology 14, no. 3 (2003 337 346, at 337.
-
(2003)
Current Opinion in Biotechnology
, vol.14
, Issue.3
, pp. 337-346
-
-
Roco, M.C.1
-
54
-
-
34248149298
-
Regulating nanomedicine
-
Editorial
-
Editorial, "Regulating Nanomedicine Nature Materials 6, no. 4 (2007 249.
-
(2007)
Nature Materials
, vol.6
, Issue.4
, pp. 249
-
-
-
55
-
-
35848960781
-
-
NanoWerk Spotlight. available at. last visited September 16, 2009). See also K. F. Schmidt, "Nanofrontiers: Visions for the Future of Nanotechnology," Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Washington, D.C., March 2007, available at. last visited August 20, 2008). http://www.nano2life.org/download/nanofrontiers-2007. pdf
-
C. Garber, "The Potential and the Pitfalls of Nanomedicine NanoWerk Spotlight, May 7, 2007, available at http://www.nanowerk.com/spotlight/spotid= 1891.php last visited September 16, 2009). See also K. F. Schmidt, "Nanofrontiers: Visions for the Future of Nanotechnology," Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Washington, D.C., March 2007, available at http://www.nano2life.org/download/ nanofrontiers-2007.pdf last visited August 20, 2008).
-
(2007)
The Potential and the Pitfalls of Nanomedicine
-
-
Garber, C.1
-
56
-
-
76149084602
-
-
See Editorial, supra note 54.
-
See Editorial, supra note 54.
-
-
-
-
57
-
-
33749820952
-
The emerging nanomedicine landscape
-
V. Wagner et al, "The Emerging Nanomedicine Landscape Nature Biotechnology 24, no. 10 (2006 1211.
-
(2006)
Nature Biotechnology
, vol.24
, Issue.10
, pp. 1211
-
-
Wagner, V.1
Al, E.2
-
58
-
-
84868187398
-
-
21 U.S.C. §§ 301-99
-
-21 U.S.C. §§ 301-99 (2009).
-
(2009)
-
-
-
59
-
-
44849094646
-
Exploring emerging nanobiotechnology drugs and medical devices
-
J. Paradise et al., "Exploring Emerging Nanobiotechnology Drugs and Medical Devices Food & Drug Law Journal 63, no. 2 (2008 407 420.
-
(2008)
Food & Drug Law Journal
, vol.63
, Issue.2
, pp. 407-420
-
-
Paradise, J.1
-
60
-
-
79955035944
-
-
See. available at. last visited September 16, 2009).
-
See Abraxis Biosciences, available at http://abraxane.com/index.aspx last visited September 16, 2009).
-
Abraxis Biosciences
-
-
-
61
-
-
84868181157
-
-
See. available at. last visited August 20, 2008).
-
See Ortho Biotech Products, LP, available at http://www.doxil.com/index. jsp last visited August 20, 2008).
-
Ortho Biotech Products, LP
-
-
-
62
-
-
84868182948
-
-
See. available at. last visited September 16, 2009).
-
See Wyeth Pharmaceuticals, available at http://www.wyeth.com/products? product=/wyeth-html/home/products/prescription/Rapamune%c2%ae%20(sirolimus)/ prescribinginfo.html last visited September 16, 2009).
-
Wyeth Pharmaceuticals
-
-
-
63
-
-
84868187396
-
-
See. Crucell-Berna Biotech. available at. last visited September 16, 2009).
-
See Crucell-Berna Biotech, available at http://www.crucell.com/Products- Epaxal last visited September 16, 2009).
-
-
-
-
64
-
-
84868180732
-
-
See. Espirit-Pharma. available at. last visited September 16, 2009).
-
See Espirit-Pharma, available at http://www.estrasorb.com last visited September 16, 2009).
-
-
-
-
65
-
-
84868174843
-
-
See. Ortho Vita, Inc. available at. last visited September 16, 2009).
-
See Ortho Vita, Inc., available at http://orthovitaportal.com/ Vitoss%20Technical%20Information/default.aspx last visited September 16, 2009).
-
-
-
-
66
-
-
84868177006
-
-
See. available at. last visited September 16, 2009).
-
See GfE Medizintechnik, available at http://www.gfe.com/opencms2/opencms/ en-gfe-online.de/GfE-Unternehmen-sprofil.html last visited September 16, 2009).
-
GfE Medizintechnik
-
-
-
67
-
-
84868172139
-
-
See. available at. last visited September 16, 2009).
-
See SurgRX, available at http://www.surgrx.com/index.php last visited September 16, 2009).
-
SurgRX
-
-
-
68
-
-
84868162017
-
-
See. available at. last visited September 16, 2009).
-
See Veridex, LLC, available at http://www.immunicon.com/CellSearch/ CSProducts/CellTracksAnalyzer.aspx last visited September 16, 2009).
-
Veridex, LLC
-
-
-
70
-
-
76149103333
-
-
Id., at 20-21.
-
Id., at 20-21.
-
-
-
-
73
-
-
76149127788
-
-
See. and AMP, Inc. v. Gardner, 389 F.2d 825 (2d Cir. 1968).
-
See United States v. Bacto-Unidisk, 394 U.S. 784 (1969) and AMP, Inc. v. Gardner, 389 F.2d 825 (2d Cir. 1968).
-
(1969)
United States V. Bacto-Unidisk, 394 U.S. 784
-
-
-
74
-
-
0020729183
-
Risk assessment in policy-making process: Environmental health and safety protection
-
and. at 142
-
J. L. Regens, T. M. Dietx, and R. W. Rycroft, "Risk Assessment in Policy-Making Process: Environmental Health and Safety Protection Public Administration Review 43, no. 2 (1983 137 145, at 142.
-
(1983)
Public Administration Review
, vol.43
, Issue.2
, pp. 137-145
-
-
Regens, J.L.1
Dietx, T.M.2
Rycroft, R.W.3
-
75
-
-
3242880319
-
Gaps, tensions and conflicts in the FDA approval process: Implications for clinical practice
-
R. A. Deyo, "Gaps, Tensions and Conflicts in the FDA Approval Process: Implications for Clinical Practice Journal of the American Board of Family Practice 17, no. 2 (2004 142 149.
-
(2004)
Journal of the American Board of Family Practice
, vol.17
, Issue.2
, pp. 142-149
-
-
Deyo, R.A.1
-
76
-
-
76149124307
-
-
Id.
-
Id.
-
-
-
-
77
-
-
7244236943
-
FDA: Evidentiary standards for drug development and approval
-
at 309.
-
R. Katz, "FDA: Evidentiary Standards for Drug Development and Approval NeuroRx 1, no. 3 (2004 307 316, at 309.
-
(2004)
NeuroRx
, vol.1
, Issue.3
, pp. 307-316
-
-
Katz, R.1
-
78
-
-
0018514829
-
Weighing the benefits and costs of medical technologies
-
and. at 1191.
-
H. D. Banta, S. Corcoran, and J. R. Sanes, "Weighing the Benefits and Costs of Medical Technologies Proceedings of the IEEE 67, no. 9 (1979 1190 1196, at 1191.
-
(1979)
Proceedings of the IEEE
, vol.67
, Issue.9
, pp. 1190-1196
-
-
Banta, H.D.1
Corcoran, S.2
Sanes, J.R.3
-
79
-
-
76149137826
-
-
See Deyo, supra note 75, at 147
-
See Deyo, supra note 75, at 147.
-
-
-
-
80
-
-
12144273882
-
How to avoid another 'vioxx'
-
at 5.
-
S. Frantz, "How to Avoid Another 'Vioxx' Nature Reviews Drug Discovery 4, no. 1 (2005 5 7, at 5.
-
(2005)
Nature Reviews Drug Discovery
, vol.4
, Issue.1
, pp. 5-7
-
-
Frantz, S.1
-
81
-
-
24644439201
-
Vioxx verdict: Too little or too much science?
-
A. Lawler, "Vioxx Verdict: Too Little or Too Much Science?" Science 309, no. 5740 (2005 1481.
-
(2005)
Science
, vol.309
, Issue.5740
, pp. 1481
-
-
Lawler, A.1
-
82
-
-
25444444353
-
Lessons from the failure and recall of an implantable cardioverter defibrillator
-
and
-
R. G. Hauser and B. J. Maron, "Lessons From the Failure and Recall of an Implantable Cardioverter Defibrillator Circulation 112, no. 13 (2005 2040 2042.
-
(2005)
Circulation
, vol.112
, Issue.13
, pp. 2040-2042
-
-
Hauser, R.G.1
Maron, B.J.2
-
83
-
-
84868183405
-
-
Letter from Vice President Reliability & Quality Assurance, Guidant Cardiac Rhythm Management, June 17, 2005, available at. last visited September 16, 2009).
-
A. Gorsett, "Urgent Medical Device Safety Information & Corrective Action: VENTAK PRIZM 2 DR, model 1981 Letter from Vice President Reliability & Quality Assurance, Guidant Cardiac Rhythm Management, June 17, 2005, available at http://www.guidant.com/physiciancommunications/PRIZM2-DR.pdf last visited September 16, 2009).
-
"urgent Medical Device Safety Information & Corrective Action: VENTAK PRIZM 2 DR, Model 1981
-
-
Gorsett, A.1
-
84
-
-
22344433607
-
The controversy over guidant's implantable defibrillators
-
This article specifically raises issues with the Heart Rhythm Society's corporate funding from Guidant, Medtronic, etc., implicating conflicts of interest. See also W. H. Maisel, "Safety Issues Involving Medical Devices: Implications of Recent Implantable Cardioverter-Defibrillator Malfunctions," JAMA 292, no. 8 (2005): 955-958.
-
R. Steinbrook, "The Controversy over Guidant's Implantable Defibrillators New England Journal of Medicine 353, no. 3 (2005 221 224. This article specifically raises issues with the Heart Rhythm Society's corporate funding from Guidant, Medtronic, etc., implicating conflicts of interest. See also W. H. Maisel, "Safety Issues Involving Medical Devices: Implications of Recent Implantable Cardioverter-Defibrillator Malfunctions," JAMA 292, no. 8 (2005): 955-958.
-
(2005)
New England Journal of Medicine
, vol.353
, Issue.3
, pp. 221-224
-
-
Steinbrook, R.1
-
85
-
-
77950267684
-
-
See. FDA. available at. last visited September 16, 2009).
-
See FDA, "Adverse Event Reporting System available at http://www.fda.gov/cder/aers/default.htm last visited September 16, 2009).
-
"adverse Event Reporting System
-
-
-
86
-
-
84868170721
-
-
FDA. available at. last visited September 16, 2009).
-
FDA, "MedWatch available at http://www.fda.gov/med-watch/ last visited September 16, 2009).
-
"medWatch
-
-
-
87
-
-
84868180730
-
-
21 C.F.R. § 314.80(c)(1)(i
-
-21 C.F.R. § 314.80(c)(1)(i 2009).
-
(2009)
-
-
-
88
-
-
84868187392
-
-
21 U.S.C. § 383.1
-
-21 U.S.C. § 383.1 (2009).
-
(2009)
-
-
-
89
-
-
68949118825
-
-
FDA. available at. last visited September 16, 2009).
-
FDA, "Manufacturer and User Facility Device Experience (MAUDE) available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search. cfm last visited September 16, 2009).
-
"manufacturer and User Facility Device Experience (MAUDE)
-
-
-
90
-
-
84868179651
-
-
31 U.S.C. § 3729 et seq.
-
-31 U.S.C. § 3729 et seq. (2009).
-
(2009)
-
-
-
91
-
-
84868187393
-
-
18 U.S.C. § 1341
-
-18 U.S.C. § 1341 (2009).
-
(2009)
-
-
-
92
-
-
84868187394
-
-
18 U.S.C. § 1001
-
-18 U.S.C. § 1001 (2009).
-
(2009)
-
-
-
93
-
-
76149084917
-
-
See Wyeth v. Levine, 129 S. Ct. 1187
-
See Wyeth v. Levine, 129 S. Ct. 1187 (2009).
-
(2009)
-
-
-
94
-
-
76149083354
-
-
Vioxx and related COX-2 inhibitors, implantable defibrillators and orthopedic products have all been subject to intense scrutiny because of some combination of perceived safety issues and industry misconduct.
-
Vioxx and related COX-2 inhibitors, implantable defibrillators and orthopedic products have all been subject to intense scrutiny because of some combination of perceived safety issues and industry misconduct.
-
-
-
-
95
-
-
0030366730
-
Substitution in regulatory agencies: FDA enforcement alternatives
-
at 404; C. E. Shipan, "Regulatory Regimes, Agency Actions, and the Conditional Nature of Congressional Influence," American Political Science Review 98, no. 3 (2004): 467-480, at 478.
-
M. Olson, "Substitution in Regulatory Agencies: FDA Enforcement Alternatives Journal of Law, Economics & Organization 12, no. 2 (1996 376 407, at 404; C. E. Shipan, "Regulatory Regimes, Agency Actions, and the Conditional Nature of Congressional Influence," American Political Science Review 98, no. 3 (2004): 467-480, at 478.
-
(1996)
Journal of Law, Economics & Organization
, vol.12
, Issue.2
, pp. 376-407
-
-
Olson, M.1
-
96
-
-
0030366730
-
Substitution in regulatory agencies: FDA enforcement alternatives
-
at 389.
-
M. Olson, "Substitution in Regulatory Agencies: FDA Enforcement Alternatives Journal of Law, Economics & Organization 12, no. 2 (1996 376 407, at 389.
-
(1996)
Journal of Law, Economics & Organization
, vol.12
, Issue.2
, pp. 376-407
-
-
Olson, M.1
-
98
-
-
33745697549
-
Representation in regulatory decision making: Scientific, industrial & consumer inputs to the FDA
-
at 206.
-
R. S. Friedman, "Representation in Regulatory Decision Making: Scientific, Industrial & Consumer Inputs to the FDA Public Administration Review 38, no. 3 (1978 205 214, at 206.
-
(1978)
Public Administration Review
, vol.38
, Issue.3
, pp. 205-214
-
-
Friedman, R.S.1
-
99
-
-
76149114693
-
-
Id.
-
Id.
-
-
-
-
100
-
-
84996224009
-
-
See. FDA. available at. last visited August 20, 2008).
-
See FDA, "FDA Advisory Committees Information available at http://www.fda.gov/cdrh/panel/overview.html last visited August 20, 2008).
-
"fDA Advisory Committees Information
-
-
-
101
-
-
76149134453
-
-
See. Friedman. supra note 98, at 213.
-
See Friedman, supra note 98, at 213.
-
-
-
-
102
-
-
55649122068
-
-
Union of Concerned Scientists. available at. last visited August 20, 2008) (peer survey of 5,918 scientists at FDA).
-
Union of Concerned Scientists, "Voices of Scientists at the FDA: Protecting Public Health Depends on Independent Science July 2006, available at http://www.ucsusa.org/news/press-release/fda-scientists-pressured.html last visited August 20, 2008) (peer survey of 5,918 scientists at FDA).
-
(2006)
"voices of Scientists at the FDA: Protecting Public Health Depends on Independent Science
-
-
-
103
-
-
84868180727
-
-
103. 21 C.F.R. §10.115
-
-103. 21 C.F.R. §10.115 (2009).
-
(2009)
-
-
-
104
-
-
84868164335
-
-
5 U.S.C. § 552
-
-5 U.S.C. § 552 (2009).
-
(2009)
-
-
-
105
-
-
84868179648
-
-
21 C.F.R. § 10.30
-
-21 C.F.R. § 10.30 (2009).
-
(2009)
-
-
-
106
-
-
76149124943
-
-
Pub. L. No. 109-41, 60 Stat. 237, codified as amended in scattered sections of 5 U.S.C.
-
Pub. L. No. 109-41, 60 Stat. 237, codified as amended in scattered sections of 5 U.S.C.
-
-
-
-
107
-
-
33750118709
-
Sometimes the silence can be like the thunder: Access to pharmaceutical data at the FDA
-
and. at 85.
-
P. Lurie and A. Zieve, "Sometimes the Silence Can be Like the Thunder: Access to Pharmaceutical Data at the FDA Law & Contemporary Problems 69 (2006 85 97, at 85.
-
(2006)
Law & Contemporary Problems
, vol.69
, pp. 85-97
-
-
Lurie, P.1
Zieve, A.2
-
108
-
-
76149103332
-
-
Id., at 95.
-
Id., at 95.
-
-
-
-
109
-
-
76149124628
-
-
Adulteration included anything insanitary or unsafe and mis-branded included anything with false or misleading claims.
-
Adulteration included anything insanitary or unsafe and mis-branded included anything with false or misleading claims.
-
-
-
-
110
-
-
84868180728
-
-
Pub. L. No. 75-717, 52 Stat. 1040. as amended 21 U.S.C. §§ 301-392 (1994).
-
Pub. L. No. 75-717, 52 Stat. 1040 (1938 as amended 21 U.S.C. §§ 301-392 (1994).
-
(1938)
-
-
-
111
-
-
0024515046
-
A history of government regulation of adulteration and misbranding of medical devices
-
P. B. Hutt, "A History of Government Regulation of Adulteration and Misbranding of Medical Devices Food Drug and Cosmetic Law Journal 99 (1989 104 105.
-
(1989)
Food Drug and Cosmetic Law Journal
, vol.99
, pp. 104-105
-
-
Hutt, P.B.1
-
112
-
-
0029417611
-
Trends and events in FDA regulation of medical devices over the last fifty years
-
R. R. Munsey, "Trends and Events in FDA Regulation of Medical Devices over the Last Fifty Years Food & Drug Law Journal 50, Special Issue (1995 163 177.
-
(1995)
Food & Drug Law Journal
, vol.50
, pp. 163-177
-
-
Munsey, R.R.1
-
113
-
-
0347141505
-
Symposium on regulating medical innovation: The architecture of government regulation of medical products
-
at 1804.
-
R. A. Merrill, "Symposium on Regulating Medical Innovation: The Architecture of Government Regulation of Medical Products Virginia Law Review 82, no. 8 (1996 1753 1866, at 1804.
-
(1996)
Virginia Law Review
, vol.82
, Issue.8
, pp. 1753-1866
-
-
Merrill, R.A.1
-
115
-
-
76149128481
-
-
AMP, Inc. v. Gardner, 389 F.2d 825 (2d Cir.
-
AMP, Inc. v. Gardner, 389 F.2d 825 (2d Cir. 1968).
-
(1968)
-
-
-
116
-
-
0037108228
-
Policy developments in regulatory approval
-
at 2939.
-
R. Temple, "Policy Developments in Regulatory Approval Statistics in Medicine 21, no. 19 (2002 2939 2948, at 2939.
-
(2002)
Statistics in Medicine
, vol.21
, Issue.19
, pp. 2939-2948
-
-
Temple, R.1
-
117
-
-
84868164337
-
-
21 U.S.C. § 355(d). Characteristics of "adequate and well controlled study" are enumerated in 21 C.F.R. § 314.126 (2009).
-
-21 U.S.C. § 355(d) (2009). Characteristics of "adequate and well controlled study" are enumerated in 21 C.F.R. § 314.126 (2009).
-
(2009)
-
-
-
119
-
-
84868174838
-
-
21 C.F.R. § 314.500, Subpart H
-
-21 C.F.R. § 314.500, Subpart H (2009).
-
(2009)
-
-
-
120
-
-
76149097979
-
-
Pub. L. No. 102-300
-
Pub. L. No. 102-300 (June 16, 1992).
-
(1992)
-
-
-
121
-
-
76149141919
-
-
Pub. L. No. 105-115
-
Pub. L. No. 105-115 (November 21, 1997).
-
(1997)
-
-
-
122
-
-
76149132768
-
-
Pub. L. No. 110-85
-
Pub. L. No. 110-85 (September 27, 2007).
-
(2007)
-
-
-
123
-
-
1042288296
-
Medical device regulation: An introduction for the practicing physician
-
W. H. Maisel, "Medical Device Regulation: An Introduction for the Practicing Physician Annals of Internal Medicine 140, no. 4 (2002 296 302.
-
(2002)
Annals of Internal Medicine
, vol.140
, Issue.4
, pp. 296-302
-
-
Maisel, W.H.1
-
124
-
-
40449088049
-
Moving toward transparency of clinical trials
-
See, e.g. and. at 1341.
-
See, e.g., D. A. Zarin and T. Tse, "Moving Toward Transparency of Clinical Trials Science 319, no. 5868 (2008 1340 1342, at 1341.
-
(2008)
Science
, vol.319
, Issue.5868
, pp. 1340-1342
-
-
Zarin, D.A.1
Tse, T.2
-
125
-
-
76149097635
-
-
Id., at 1342.
-
Id., at 1342.
-
-
-
-
126
-
-
76149099019
-
-
Harris Interactive. available at. last visited September 16, 2009) (online survey from May 12-16, 2006 of 2,371 U.S. adults).
-
Harris Interactive, "The FDA's Reputation with the General Public Is Under Assault May 26, 2006, available at http://www.harrisinteractive.com/news/ allnewsbydate.asp?NewsID=1060 last visited September 16, 2009) (online survey from May 12-16, 2006 of 2,371 U.S. adults).
-
(2006)
"the FDA's Reputation with the General Public Is under Assault
-
-
-
127
-
-
84868174837
-
-
American University Center for Congressional and Presidential Studies. available at. last visited September 16, 2009). See also S. Reinberg, "Americans Confused About FDA and Drug Safety," U.S. News & World Report, September 20, 2007, available at. last visited September 16, 2009) (phone survey of 800 adults between September 4-6, 2007). http://health.usnews. com/usnews/health/health-day/070920/americans-confused-about-fda-and-drug- safety.htm
-
American University Center for Congressional and Presidential Studies, "A Dialogue on Prescription Drug Safety: Seeking Common Ground available at http://www.dialogueondrugsafety.org/ last visited September 16, 2009). See also S. Reinberg, "Americans Confused About FDA and Drug Safety," U.S. News & World Report, September 20, 2007, available at http://health.usnews. com/usnews/health/health-day/070920/americans-confused-about-fda-and-drug- safety.htm last visited September 16, 2009) (phone survey of 800 adults between September 4-6, 2007).
-
"a Dialogue on Prescription Drug Safety: Seeking Common Ground
-
-
-
128
-
-
76149140255
-
-
See. Union of Concerned Scientists. supra note 102.
-
See Union of Concerned Scientists, supra note 102.
-
-
-
-
129
-
-
76149087875
-
-
Harris Interactive. available at. last visited September 16, 2009) (online survey of 2,476 U.S. adults from April 1-4, 2008).
-
Harris Interactive, "Confidence in FDA Hits New Low, According to WSJ.com/Harris Interactive Study April 22, 2008, available at http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=1301 last visited September 16, 2009) (online survey of 2,476 U.S. adults from April 1-4, 2008).
-
(2008)
Confidence in FDA Hits New Low, According to WSJ.com/Harris Interactive Study
-
-
-
130
-
-
76149089628
-
-
See Deyo, supra note 75
-
See Deyo, supra note 75.
-
-
-
-
131
-
-
33750135446
-
FDA revamps committee conflict-of-interest rules
-
J. B. Finkelstein, "FDA Revamps Committee Conflict-of-interest Rules Journal of the National Cancer Institute 98, no. 19 (2006 1354.
-
(2006)
Journal of the National Cancer Institute
, vol.98
, Issue.19
, pp. 1354
-
-
Finkelstein, J.B.1
-
133
-
-
34250213671
-
User-fee bill passes U.S. senate, but legislative hurdles remain
-
J. L. Fox, "User-Fee Bill Passes U.S. Senate, But Legislative Hurdles Remain Nature Biotechnology 25, no. 6 (2007 611.
-
(2007)
Nature Biotechnology
, vol.25
, Issue.6
, pp. 611
-
-
Fox, J.L.1
-
134
-
-
76149090589
-
-
See. FDA. supra note 69.
-
See FDA, supra note 69.
-
-
-
|