-
1
-
-
84872049497
-
Crizotinib Is "major breakthrough for genomic medicine."
-
Web site. Published September 1 2011 Accessed September 29
-
Nelson R. Crizotinib is "major breakthrough for genomic medicine." Medscape Web site. http://www.medscape.com/viewarticle/748990. Published September 1, 2011. Accessed September 29, 2011.
-
(2011)
Medscape
-
-
Nelson, R.1
-
2
-
-
84872022122
-
Regulatory approval for new pharmacogenomic tests: A comparative overview
-
Joly Y, Koutrikas G, Tassee AM, et al. Regulatory approval for new pharmacogenomic tests: A comparative overview. Food Drug Law J. 2011;66: 1-24.
-
(2011)
Food Drug Law J.
, vol.66
, pp. 1-24
-
-
Joly, Y.1
Koutrikas, G.2
Tassee, A.M.3
-
3
-
-
84863992950
-
Right question wrong answer: A response to professor epstein and the "permititis" challenge
-
Hall RF. Right question, wrong answer: A response to Professor Epstein and the "permititis" challenge. Minn Law Rev Headnotes. 2010;94:50-84.
-
(2010)
Minn Law Rev Headnotes.
, vol.94
, pp. 50-84
-
-
Hall, R.F.1
-
4
-
-
84872030782
-
-
Thalidomide-A Second Chance [program Summary]? BBC Web Site. Accessed 12/3/11
-
Thalidomide-a second chance [program summary]? BBC Web site. http:// www.bbc.co.uk/science/horizon/2004/thalidomide.shtml. Accessed 12/3/11.
-
-
-
-
5
-
-
79551671224
-
Against permititis: Why voluntary organizations should regulate the use of cancer drugs
-
Epstein RA. Against permititis: Why voluntary organizations should regulate the use of cancer drugs. Minn Law Rev. 2009;94:1-42.
-
(2009)
Minn Law Rev.
, vol.94
, pp. 1-42
-
-
Epstein, R.A.1
-
6
-
-
80051854118
-
Off-label prescription advertising, the FDA, and the First Amendment: A study in the values of commercial speech protection
-
Klasmeier C, Redish MH. Off-label prescription advertising, the FDA, and the First Amendment: A study in the values of commercial speech protection. Am J Law Med. 2011;37(2-3):315-357.
-
(2011)
Am J Law Med.
, vol.37
, Issue.2-3
, pp. 315-357
-
-
Klasmeier, C.1
Redish, M.H.2
-
7
-
-
80052966031
-
Metabolic effects of albumin therapy in acute lung injury measured by proton nuclear magnetic resonance spectroscopy of plasma: A pilot study
-
Park Y, Jones DP, Ziegler TR, et al. Metabolic effects of albumin therapy in acute lung injury measured by proton nuclear magnetic resonance spectroscopy of plasma: A pilot study. Crit Care Med. 2011;39(10):2308-2313.
-
(2011)
Crit Care Med.
, vol.39
, Issue.10
, pp. 2308-2313
-
-
Park, Y.1
Jones, D.P.2
Ziegler, T.R.3
-
8
-
-
78649646805
-
The Food and Drug Administration's paternalism
-
Somberg JC. The Food and Drug Administration's paternalism. Am J Ther. 2010;17(6):533-534.
-
(2010)
Am J Ther.
, vol.17
, Issue.6
, pp. 533-534
-
-
Somberg, J.C.1
-
9
-
-
84872049888
-
-
Accessed January Forbes. November 7, 2011.
-
Pipes S. It's time to blow up the FDA's drug review process. Forbes. November 7, 2011. http://www.forbes.com/sites/sallypipes/2011/11/07/its-timeto- blow-up-the-fdas-drug-review-process/. Accessed January 5, 2012.
-
It's Time To Blow Up The FDA's Drug Review Process
, vol.5
, pp. 2012
-
-
Pipes, S.1
-
10
-
-
78650325817
-
Development and regulatory strategies for drug and diagnostic co-development
-
Hinman LM, Carl KM, Spear BB, et al. Development and regulatory strategies for drug and diagnostic co-development. Pharmacogenomics. 2010; 11(12):1669-1675.
-
(2010)
Pharmacogenomics.
, vol.11
, Issue.12
, pp. 1669-1675
-
-
Hinman, L.M.1
Carl, K.M.2
Spear, B.B.3
-
11
-
-
79953776430
-
Strengths and weaknesses of FDA-approved/cleared diagnostic devices for the molecular detection of respiratory pathogens
-
Ginocchio CC. Strengths and weaknesses of FDA-approved/cleared diagnostic devices for the molecular detection of respiratory pathogens. Clin Infect Dis. 2011;52(suppl 4):S312-S325.
-
(2011)
Clin Infect Dis.
, vol.52
, Issue.SUPPL. 4
-
-
Ginocchio, C.C.1
-
12
-
-
78650905902
-
SIMD commentary on FDA oversight of laboratorydeveloped testing
-
Vladutiu GD. SIMD commentary on FDA oversight of laboratorydeveloped testing. Mol Genet Metab. 2011;102(1):1-3.
-
(2011)
Mol Genet Metab.
, vol.102
, Issue.1
, pp. 1-3
-
-
Vladutiu, G.D.1
-
13
-
-
82555194532
-
College of American Pathologists proposal for the oversight of laboratory-developed tests
-
Vance GH. College of American Pathologists proposal for the oversight of laboratory-developed tests. Arch Pathol Lab Med. 2011;135(11):1432-1435.
-
(2011)
Arch Pathol Lab Med.
, vol.135
, Issue.11
, pp. 1432-1435
-
-
Vance, G.H.1
-
14
-
-
84872018324
-
-
College Of American Pathologists. Comments To The Food And Drug Administration On The Draft Guidance "In Vitro Companion Diagnostic Devices. Published October 12, 2011. Accessed Accessed January 5, 2012
-
College of American Pathologists. Comments to the Food and Drug Administration on the draft guidance "In Vitro Companion Diagnostic Devices." http://www.cap.org/apps/docs/advocacy/comments/comments-fda- draft-guidance. pdf. Published October 12, 2011. Accessed Accessed January 5, 2012.
-
-
-
-
15
-
-
84872037842
-
Bumpy landing for precision medicine
-
50, 52,54,56
-
Paxton A. Bumpy landing for precision medicine. CAP Today. 2011,25:1, 50, 52, 54, 56.
-
(2011)
CAP Today.
, vol.25
, pp. 1
-
-
Paxton, A.1
-
16
-
-
84872049366
-
-
ADVANCE Discourse: Lab. Published December 9, 2011. Accessed November 5, 2011
-
Hoffman J. AMP comments on FDA companion diagnostic devices draft guidance. ADVANCE Discourse: Lab. http://community.advanceweb.com/blogs/ al-2/archive/2011/12/09/amp-comments-on-fda-companion-diagnostic-devicesdraft- guidance.aspx. Published December 9, 2011. Accessed November 5, 2011.
-
AMP comments on FDA companion diagnostic devices draft guidance
-
-
Hoffman, J.1
-
17
-
-
84872026089
-
-
Association For Molecular Pathology. AMP Comments Regarding FDA Draft Guidance For "in vitro companion diagnostic devices." Accessed January 5, 2012
-
Association for Molecular Pathology. AMP comments regarding FDA draft guidance for "in vitro companion diagnostic devices." http://www.amp. org/publications-resources/position-statements-letters/documents/AMPResponse CompanionDx-Final.pdf. Accessed January 5, 2012.
-
-
-
-
18
-
-
84872015654
-
-
What Pathologists And The CAP Can Do To Assist With PMA Process. Digital Pathology Blog Web Site. Accessed January 5, 2012
-
What pathologists and the CAP can do to assist with PMA process. Digital Pathology Blog Web site. http://www.tissuepathology.com/weblog/2011/12/ what-pathologists-and-the-cap-can-do-to-assist-with-pma-process.html. Accessed January 5, 2012.
-
-
-
|