-
1
-
-
84884669213
-
-
Food, Drug, and Cosmetic Act, 21 U.S.C. 321(h); definition of the term 'device' ('an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is [2] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals')
-
Food, Drug, and Cosmetic Act, 21 U.S.C. 321(h); definition of the term 'device' ('an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is [2] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals').
-
-
-
-
2
-
-
84884672618
-
-
21 CFR §809.3(a); definition of in vitro diagnostic devices ('In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis, of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequebe. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act'), available at FDA (cited 1st April
-
CFR §809.3(a); definition of in vitro diagnostic devices ('In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis, of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequebe. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act'), available at http:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm, FDA (cited 1st April, 2004).
-
(2004)
-
-
-
3
-
-
2542641907
-
FDA White Paper: 'Innovation or stagnation, challenge and opportunity on the critical path to new medical products'
-
FDA available at Updated March 29th, 2004; accessed 1st September, 2005
-
FDA (2004), FDA White Paper: 'Innovation or stagnation, challenge and opportunity on the critical path to new medical products', available at http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html. Updated March 29th, 2004; accessed 1st September, 2005.
-
(2004)
-
-
-
4
-
-
32044447292
-
'Pharmacogenomics in drug development and regulatory decision making' - Workshop 3: 'Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines'
-
11-13th April, Bethesda, MD
-
'Pharmacogenomics in drug development and regulatory decision making' - Workshop 3: 'Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines', 11-13th April, 2005, Bethesda, MD.
-
(2005)
-
-
-
5
-
-
20844447913
-
'Co-development of drug, biological and device products'
-
FDA/Drug Information Association 29th July, 2004, Arlington, VA, Accessed 1st September, 2005. available at
-
FDA/Drug Information Association (2004), 'Co-development of drug, biological and device products', 29th July, 2004, Arlington, VA, available at http://www.diahome.org/Content/Events/04040.pdf. Accessed 1st September, 2005.
-
(2004)
-
-
-
6
-
-
32044462342
-
'Drug metabolizing enzymes and pharmacogenomics' - A joint FDA/Johns Hopkins University/PhRMA educational workshop
-
13-14th September, Rockville, MD
-
'Drug metabolizing enzymes and pharmacogenomics' - a joint FDA/Johns Hopkins University/PhRMA educational workshop, 13-14th September, 2004, Rockville, MD.
-
(2004)
-
-
-
7
-
-
1542333321
-
'Guidance for industry: Pharmacogenomic data submissions'
-
FDA available at Posted 31st March, 2005; accessed 1st September, 2005
-
FDA (2005), 'Guidance for industry: Pharmacogenomic data submissions', available at http://www.fda.gov/cber/gdlns/pharmdtasub.pdf. Posted 31st March, 2005; accessed 1st September, 2005.
-
(2005)
-
-
-
8
-
-
4644304861
-
'Multiplex tests for heritable DNA markers, mutations and expression patterns: Draft guidance for industry and FDA reviewers'
-
FDA March, available at Updated 21st April, 2003; accessed 1st September, 2005
-
FDA (2003), 'Multiplex tests for heritable DNA markers, mutations and expression patterns: Draft guidance for industry and FDA reviewers', March, available at http://www.fda.gov/cdrh/oivd/guidance/1210.html. Updated 21st April, 2003; accessed 1st September, 2005.
-
(2003)
-
-
-
9
-
-
84884674905
-
FDA White Paper: 'Drug-device co-development concept paper (draft) April'
-
FDA available at Posted 8th April, 2005, accessed 1st September, 2005
-
FDA (2005), FDA White Paper: 'Drug-device co-development concept paper (draft) April', available at http://www.fda.gov/cder/genomics/ pharmacoconceptfn.pdf. Posted 8th April, 2005, accessed 1st September, 2005.
-
(2005)
-
-
-
10
-
-
32044432666
-
'Microarrays in transcriptional profiling' - A joint FDA/Johns Hopkins University/PhRMA workshop
-
20-21st July, Rockville, MD
-
'Microarrays in transcriptional profiling' - a joint FDA/Johns Hopkins University/PhRMA workshop, 20-21st July, 2005, Rockville, MD.
-
(2005)
-
-
-
11
-
-
8644252736
-
'Prediction of survival in follicular lymphoma based on molecular features of tumor-infiltrating immune cells'
-
Dave, S.S., Wright, G., Tan, B. et al. (2004), 'Prediction of survival in follicular lymphoma based on molecular features of tumor-infiltrating immune cells', N. Engl. J. Med. Vol. 351, pp. 2159-2169.
-
(2004)
N. Engl. J. Med.
, vol.351
, pp. 2159-2169
-
-
Dave, S.S.1
Wright, G.2
Tan, B.3
-
12
-
-
0037407908
-
'Molecular diagnosis of the hematologic cancers'
-
Staudt, L.M. (2003), 'Molecular diagnosis of the hematologic cancers', N. Engl. J. Med. Vol. 348, pp. 1777-1785.
-
(2003)
N. Engl. J. Med.
, vol.348
, pp. 1777-1785
-
-
Staudt, L.M.1
-
13
-
-
8444246272
-
'QA/QC: Challenges and pitfalls facing the microarray community and regulatory agencies'
-
Shi, L., Tong, W., Goodsaid, F. et al. (2004), 'QA/QC: Challenges and pitfalls facing the microarray community and regulatory agencies', Expert Rev. Mol. Diagn. Vol. 4, pp. 761-777.
-
(2004)
Expert Rev. Mol. Diagn.
, vol.4
, pp. 761-777
-
-
Shi, L.1
Tong, W.2
Goodsaid, F.3
-
14
-
-
2942576225
-
'Sources of variability and effect of experimental approach on expression profiling data interpretation'
-
available at Published 31st January, 2002; accessed 1st September, 2005
-
Bakay, M., Chen, Y.W., Borup, R. et al. (2002), 'Sources of variability and effect of experimental approach on expression profiling data interpretation', BMC Bioinformatics [Internet] Vol. 3, p. 4, available at http://www.biomedcentral.com/1471-2105/3/4. Published 31st January, 2002; accessed 1st September, 2005.
-
(2002)
BMC Bioinformatics [Internet]
, vol.3
, pp. 4
-
-
Bakay, M.1
Chen, Y.W.2
Borup, R.3
-
15
-
-
18244389201
-
'Standardizing global gene expression analysis between laboratories and across platforms'
-
(Members of the Toxicogenomics Research Consortium)
-
Bammler, T., Beyer. R.P., Bhattacharya, S. et al. (Members of the Toxicogenomics Research Consortium) (2005), 'Standardizing global gene expression analysis between laboratories and across platforms', Nat. Methods Vol. 2, pp. 351-356.
-
(2005)
Nat. Methods
, vol.2
, pp. 351-356
-
-
Bammler, T.1
Beyer, R.P.2
Bhattacharya, S.3
-
16
-
-
18244384210
-
'Multiple-laboratory comparison of microarray platforms'
-
Irizarry, R.A., Warren, D., Spencer, F. et al. (2005), 'Multiple-laboratory comparison of microarray platforms', Nat. Methods Vol. 2, pp. 345-350.
-
(2005)
Nat. Methods
, vol.2
, pp. 345-350
-
-
Irizarry, R.A.1
Warren, D.2
Spencer, F.3
-
17
-
-
18244378238
-
'Independence and reproducibility across microarray platforms'
-
Larkin, J.E., Frank, B.C., Gavras, H. et al. (2005), 'Independence and reproducibility across microarray platforms', Nat. Methods Vol. 2, pp. 337-344.
-
(2005)
Nat. Methods
, vol.2
, pp. 337-344
-
-
Larkin, J.E.1
Frank, B.C.2
Gavras, H.3
-
18
-
-
32044434056
-
'Interrogation of microarray platform variation and performance with a mixed tissue RNA reference material', at 'Microarrays in transcriptional profiling' - A joint FDA/Johns Hopkins University/PhRMA workshop
-
20-21st July, Rockville, MD
-
Thompson, K. (2005), 'Interrogation of microarray platform variation and performance with a mixed tissue RNA reference material', at 'Microarrays in transcriptional profiling' - a joint FDA/Johns Hopkins University/ PhRMA workshop, 20-21st July, Rockville, MD.
-
(2005)
-
-
Thompson, K.1
-
19
-
-
23644453736
-
'Three microarray platforms: An analysis of their concordance in profiling gene expression'
-
available at Published 5th May, 2005; accessed 1st September, 2005
-
Petersen, D., Chandramouli, G.V.R., Geoghegan, J. et al. (2005), 'Three microarray platforms: An analysis of their concordance in profiling gene expression', BMC Genomics [Internet] Vol. 6, p. 63, available at http://www.biomedcentral.com/1471-2164/6/63. Published 5th May, 2005; accessed 1st September, 2005.
-
(2005)
BMC Genomics [Internet]
, vol.6
, pp. 63
-
-
Petersen, D.1
Chandramouli, G.V.R.2
Geoghegan, J.3
-
20
-
-
27644528185
-
'Cross-platform comparability of microarray technology: Intra-platform consistency and appropriate data analysis procedures are essential'
-
available at Published 15th July, 2005, accessed 1st September, 2005
-
Shi, L., Tong, W. and Fang, H. et al. (2005), 'Cross-platform comparability of microarray technology: Intra-platform consistency and appropriate data analysis procedures are essential', BMC Bioinformatics [Internet] Vol. 6(Suppl. 2), pp. S12, available at http://www.biomedcentral.com/1471-2105/6/S2/S12. Published 15th July, 2005, accessed 1st September, 2005.
-
(2005)
BMC Bioinformatics [Internet]
, vol.6
, Issue.SUPPL. 2
-
-
Shi, L.1
Tong, W.2
Fang, H.3
-
21
-
-
1542290446
-
'Expression profiling-best practices for data generation and interpretation in clinical trials'
-
The Tumor Analysis Best Practices Working Group
-
The Tumor Analysis Best Practices Working Group (2004), 'Expression profiling-best practices for data generation and interpretation in clinical trials', Nat. Rev. Genetics Vol. 5, pp. 229-237.
-
(2004)
Nat. Rev. Genetics
, vol.5
, pp. 229-237
-
-
-
22
-
-
0142121516
-
'Exploration, normalization, and summaries of high density oligonucleotide array probe level data'
-
Irizarry, R.A., Hobbs, B., Collin, F. et al. (2004), 'Exploration, normalization, and summaries of high density oligonucleotide array probe level data', Biostatistics Vol. 4, pp. 249-264.
-
(2004)
Biostatistics
, vol.4
, pp. 249-264
-
-
Irizarry, R.A.1
Hobbs, B.2
Collin, F.3
-
23
-
-
32044445134
-
'Diagnostic nucleic acid microarrays'
-
Clinical and Laboratory Standards Institute (CLSI) proposed guideline, Document MM12-P
-
Clinical and Laboratory Standards Institute (CLSI) (2005), 'Diagnostic nucleic acid microarrays', proposed guideline, Document MM12-P.
-
(2005)
-
-
-
24
-
-
25444515422
-
'Redefinition of Affymetrix probe sets by sequence overlap with cDNA microarray probes reduces cross-platform inconsistencies in cancer-associated gene expression measurements'
-
available at Published 25th April, 2005; accessed 1st September, 2005
-
Carter, S.L., Eklund, A.C., Mecham, B.H. et al. (2005), 'Redefinition of Affymetrix probe sets by sequence overlap with cDNA microarray probes reduces cross-platform inconsistencies in cancer-associated gene expression measurements', BMC Bioinformatics [Internet] Vol. 6, p. 107, available at http://www.biomedcentral.com/1471-2105/6/107. Published 25th April, 2005; accessed 1st September, 2005.
-
(2005)
BMC Bioinformatics [Internet]
, vol.6
, pp. 107
-
-
Carter, S.L.1
Eklund, A.C.2
Mecham, B.H.3
-
25
-
-
13444283596
-
'Bias as a threat to the validity of cancer molecular-marker research'
-
Ransohoff, D.F. (2005), 'Bias as a threat to the validity of cancer molecular-marker research', Nat. Rev. Cancer Vol. 5, pp. 142-149.
-
(2005)
Nat. Rev. Cancer
, vol.5
, pp. 142-149
-
-
Ransohoff, D.F.1
-
26
-
-
1942438016
-
'Rules of evidence for cancer molecular-marker discovery and validation'
-
Ransohoff, D.F. (2004), 'Rules of evidence for cancer molecular-marker discovery and validation', Nat. Rev. Cancer Vol. 4, pp. 309-314.
-
(2004)
Nat. Rev. Cancer
, vol.4
, pp. 309-314
-
-
Ransohoff, D.F.1
-
27
-
-
21444445077
-
'Development and validation of therapeutically relevant multi-gene biomarker classifiers'
-
Simon, R. (2005), 'Development and validation of therapeutically relevant multi-gene biomarker classifiers', J. Natl. Cancer Inst. Vol. 97, pp. 866-867.
-
(2005)
J. Natl. Cancer Inst.
, vol.97
, pp. 866-867
-
-
Simon, R.1
-
28
-
-
0037245343
-
'Pitfalls in the analysis of DNA microarray data: Class prediction methods'
-
Simon, R., Radmacher, M.D., Dobbin, K. and McShane, L.M. (2003), 'Pitfalls in the analysis of DNA microarray data: Class prediction methods', J. Natl. Cancer Inst. Vol. 95, pp. 14-18.
-
(2003)
J. Natl. Cancer Inst.
, vol.95
, pp. 14-18
-
-
Simon, R.1
Radmacher, M.D.2
Dobbin, K.3
McShane, L.M.4
-
29
-
-
0344441000
-
'Diagnostic and prognostic prediction using gene expression profiles in high dimensional microarray data'
-
Simon, R. (2003), 'Diagnostic and prognostic prediction using gene expression profiles in high dimensional microarray data', Br. J. Cancer Vol. 89, pp. 1599-1604.
-
(2003)
Br. J. Cancer
, vol.89
, pp. 1599-1604
-
-
Simon, R.1
-
30
-
-
84884672025
-
'Designing prospective clinical PG trials - Effective use of genomic biomarkers for use in clinical decision-making'
-
In press
-
Trepicchio, W.L., Essayan, D., Hall, S.T. et al. (2006), 'Designing prospective clinical PG trials - Effective use of genomic biomarkers for use in clinical decision-making', Pharmacogenomics J., In press.
-
(2006)
Pharmacogenomics J.
-
-
Trepicchio, W.L.1
Essayan, D.2
Hall, S.T.3
-
31
-
-
0035184770
-
'High-throughput variation detection and genotyping using microarrays'
-
Cutler, D.J., Zwick, M.E., Carrasquillo, M.M. et al. (2001), 'High-throughput variation detection and genotyping using microarrays', Genome Res. Vol. 11, pp. 1913-1925.
-
(2001)
Genome Res.
, vol.11
, pp. 1913-1925
-
-
Cutler, D.J.1
Zwick, M.E.2
Carrasquillo, M.M.3
-
32
-
-
0035654137
-
'Accessing genetic variation: Genotyping single nucleotide polymorphisms'
-
Syvanen, A.C. (2001), 'Accessing genetic variation: Genotyping single nucleotide polymorphisms', Nature Rev. Genet. Vol. 2, pp. 930-942.
-
(2001)
Nature Rev. Genet.
, vol.2
, pp. 930-942
-
-
Syvanen, A.C.1
-
33
-
-
18344364081
-
'New developments in high-throughput resequencing and variation detection using high density microarrays'
-
Warrington, J.A., Shah, N.A., Chen, X. et al. (2002), 'New developments in high-throughput resequencing and variation detection using high density microarrays', Hum. Mutat. Vol. 19, pp. 402-409.
-
(2002)
Hum. Mutat.
, vol.19
, pp. 402-409
-
-
Warrington, J.A.1
Shah, N.A.2
Chen, X.3
-
34
-
-
18744377158
-
'Microarray-based detection and genotyping of viral pathogens'
-
Wang, D., Coscoy, L., Zylberberg, M. et al. (2002), 'Microarray-based detection and genotyping of viral pathogens', Proc. Natl. Acad. Sci. USA Vol. 99, pp. 15687-15692.
-
(2002)
Proc. Natl. Acad. Sci. USA
, vol.99
, pp. 15687-15692
-
-
Wang, D.1
Coscoy, L.2
Zylberberg, M.3
-
35
-
-
0042922317
-
'Microarray-based identification of thermophilic Campylobacter jejuni, C. coli, C. lari, and C. upsaliensis'
-
Volokhov, D., Chizhikov, V., Chumakov, K. and Rasooly A. (2003), 'Microarray-based identification of thermophilic Campylobacter jejuni, C. coli, C. lari, and C. upsaliensis', J. Clin. Microbiol. Vol. 41, pp. 4071-4080.
-
(2003)
J. Clin. Microbiol.
, vol.41
, pp. 4071-4080
-
-
Volokhov, D.1
Chizhikov, V.2
Chumakov, K.3
Rasooly, A.4
-
36
-
-
15944384859
-
'Microarray-based resequencing of multiple Bacillus anthracis isolates'
-
available at Published 17th December, 2004; accessed 1st September, 2005
-
Zwick, M.E., Mcafee, F., Cutler, D.J. et al. (2005), 'Microarray-based resequencing of multiple Bacillus anthracis isolates', Genome Biol. [Internet] Vol. 6, pp. R10, available at http://genomebiology.com/2004/6/ 1/R10. Published 17th December, 2004; accessed 1st September, 2005.
-
(2005)
Genome Biol. [Internet]
, vol.6
-
-
Zwick, M.E.1
Mcafee, F.2
Cutler, D.J.3
-
37
-
-
4544253691
-
'Pharmacogenomics: Bench to bedside'
-
Weinshilboum, R. and Wang, L. (2004), 'Pharmacogenomics: bench to bedside', Nat. Rev. Drug Discov. Vol. 3, pp. 739-748.
-
(2004)
Nat. Rev. Drug Discov.
, vol.3
, pp. 739-748
-
-
Weinshilboum, R.1
Wang, L.2
-
38
-
-
4544335467
-
'Translation of pharmacogenomics and pharmacogenetics: A regulatory perspective'
-
Lesko, L. and Woodcock, J. (2004), 'Translation of pharmacogenomics and pharmacogenetics: A regulatory perspective', Nat. Rev. Drug Discov. Vol. 3, pp. 763-770.
-
(2004)
Nat. Rev. Drug Discov.
, vol.3
, pp. 763-770
-
-
Lesko, L.1
Woodcock, J.2
-
39
-
-
25144504852
-
'FDA perspectives on pharmacogenetic testing'
-
Harper, CC., Philip, R., Robinowitz, M. and Gutman, S.I (2005), 'FDA perspectives on pharmacogenetic testing', Expert Rev. Mol. Diagn. Vol. 5, pp. 643-648.
-
(2005)
Expert Rev. Mol. Diagn.
, vol.5
, pp. 643-648
-
-
Harper, C.C.1
Philip, R.2
Robinowitz, M.3
Gutman, S.I.4
-
40
-
-
3242808027
-
'Large-scale copy number polymorphism in the human genome'
-
Sebat, J., Lakshmi, B., Troge, J. et al. (2004), 'Large-scale copy number polymorphism in the human genome', Science Vol. 305, pp. 525-528.
-
(2004)
Science
, vol.305
, pp. 525-528
-
-
Sebat, J.1
Lakshmi, B.2
Troge, J.3
-
41
-
-
4444291843
-
'Detection of large-scale variation in the human genome'
-
Iafrate, A.J., Feuk, L., Rivera, M.N. et al. (2004), 'Detection of large-scale variation in the human genome', Nat. Genet. Vol. 36, pp. 949-951.
-
(2004)
Nat. Genet.
, vol.36
, pp. 949-951
-
-
Iafrate, A.J.1
Feuk, L.2
Rivera, M.N.3
-
42
-
-
4444375366
-
'As normal as normal can be?'
-
Carter, N.P. (2004), 'As normal as normal can be?', Nat. Genet. Vol. 36, pp. 931-932.
-
(2004)
Nat. Genet.
, vol.36
, pp. 931-932
-
-
Carter, N.P.1
-
44
-
-
23444459574
-
'Array CGH technologies and their applications to cancer genomes'
-
Davies, J.J., Wilson, I.M. and Lam, W.L. (2005), 'Array CGH technologies and their applications to cancer genomes', Chromosome Res. Vol. 13, pp. 237-248.
-
(2005)
Chromosome Res.
, vol.13
, pp. 237-248
-
-
Davies, J.J.1
Wilson, I.M.2
Lam, W.L.3
-
45
-
-
10744233914
-
'A tiling resolution DNA microarray with complete coverage of the human genome'
-
Ishkanian, A.S., Malloff, C.A., Watson, S.K. et al. (2004), 'A tiling resolution DNA microarray with complete coverage of the human genome', Nat. Genet. Vol. 36, pp. 299-303.
-
(2004)
Nat. Genet.
, vol.36
, pp. 299-303
-
-
Ishkanian, A.S.1
Malloff, C.A.2
Watson, S.K.3
-
46
-
-
19944418773
-
'Comparative genomic hybridization using oligonucleotide microarrays and total genomic DNA'
-
Barrett, M.T., Scheffer, A., Ben-Dor, A. et al. (2004), 'Comparative genomic hybridization using oligonucleotide microarrays and total genomic DNA', Proc. Natl. Acad. Sci. USA Vol. 101, pp. 17765-17770.
-
(2004)
Proc. Natl. Acad. Sci. USA
, vol.101
, pp. 17765-17770
-
-
Barrett, M.T.1
Scheffer, A.2
Ben-Dor, A.3
-
47
-
-
17644397384
-
'Exon array CGH: Detection of copy-number changes at the resolution of individual exons in the human genome'
-
Dhami, P., Coffey, A.J., Abbs, S. et al. (2005), 'Exon array CGH: detection of copy-number changes at the resolution of individual exons in the human genome', Am. J. Hum. Genet. Vol. 76, pp. 750-762.
-
(2005)
Am. J. Hum. Genet.
, vol.76
, pp. 750-762
-
-
Dhami, P.1
Coffey, A.J.2
Abbs, S.3
-
48
-
-
22144458387
-
'Denoising array-based comparative genomic hybridization data using wavelets'
-
Hsu, L., Self, S.G., Grove, D. et al. (2005), 'Denoising array-based comparative genomic hybridization data using wavelets', Biostatistics Vol. 6, pp. 211-226.
-
(2005)
Biostatistics
, vol.6
, pp. 211-226
-
-
Hsu, L.1
Self, S.G.2
Grove, D.3
-
49
-
-
14644437012
-
'Food and Drug Administration regulation of in vitro diagnostic devices'
-
Mansfield, E., O'Leary, T.J. and Gutman, S.I. (2005), 'Food and Drug Administration regulation of in vitro diagnostic devices', J. Mol. Diagn. Vol. 7, pp. 2-7.
-
(2005)
J. Mol. Diagn.
, vol.7
, pp. 2-7
-
-
Mansfield, E.1
O'Leary, T.J.2
Gutman, S.I.3
-
50
-
-
84884675219
-
'Evaluation of automatic Class III designation, guidance for industry and CDRH staff'
-
FDA New Section 513(f)(2) - February 1998 available at Updated 28th September, 2004; accessed 1st September, 2005
-
FDA (1998), New Section 513(f)(2) - 'Evaluation of automatic Class III designation, guidance for industry and CDRH staff', February 1998, available at http://www.fda.gov/cdrh/modact/classiii.html. Updated 28th September, 2004; accessed 1st September, 2005.
-
(1998)
-
-
-
51
-
-
84884672148
-
'The pre-IDE process'
-
presentation at the IVD 510(k) Workshop, 22nd April, 2003, Rockville, MD, available at FDA. Updated 20th May, 2003; accessed 1st September, 2005
-
Altaie, S. (2003), 'The pre-IDE process', presentation at the IVD 510(k) Workshop, 22nd April, 2003, Rockville, MD, available at http://www.fda.gov/cdrh/oivd/presentations/042203-Altaie.html, FDA. Updated 20th May, 2003; accessed 1st September, 2005.
-
(2003)
-
-
Altaie, S.1
-
52
-
-
32044457995
-
Class II special controls guidance document: 'Drug metabolizing enzyme genotyping system - Guidance for industry and FDA staff'
-
FDA available at Posted 9th March, 2005; accessed 1st September, 2005
-
FDA (2005), Class II special controls guidance document: 'Drug metabolizing enzyme genotyping system - Guidance for industry and FDA staff', available at http://www.fda.gov/cdrh/oivd/guidance/1551.html. Posted 9th March, 2005; accessed 1st September, 2005.
-
(2005)
-
-
-
53
-
-
84884673758
-
'Instrumentation for clinical multiplex test systems: Class II special controls guidance document - Guidance for industry and FDA staff'
-
FDA available at Posted 9th March, 2005; accessed 1st September, 2005
-
FDA (2005), 'Instrumentation for clinical multiplex test systems: Class II special controls guidance document - Guidance for industry and FDA staff', available at http://www.fda.gov/cdrh/oivd/guidance/1546.pdf. Posted 9th March, 2005; accessed 1st September, 2005.
-
(2005)
-
-
-
54
-
-
84884675166
-
'CFTR gene mutation detection systems: Class II special controls guidance document - Guidance for industry and FDA staff'
-
FDA available at Posted 25th October, 2005
-
FDA (2005), 'CFTR gene mutation detection systems: Class II special controls guidance document - Guidance for industry and FDA staff', available at http://www.fda.gov/cdrh/oivd/guidance/1564.pdf. Posted 25th October, 2005.
-
(2005)
-
-
-
55
-
-
84884671537
-
-
NIST
-
NIST (2003), http://www.cstl.nist.gov/biotech/workshops/ERCC2003/.
-
(2003)
-
-
-
56
-
-
32044457783
-
'Use of external RNA controls in gene expression assays'
-
FDA/NCTR proposed guideline, Clinical and Laboratory Standards Institute (CLSI), Document MM16-P
-
FDA/NCTR (2005). 'Use of external RNA controls in gene expression assays', proposed guideline, Clinical and Laboratory Standards Institute (CLSI), Document MM16-P.
-
(2005)
-
-
-
57
-
-
84884671031
-
-
Cited 29th August
-
http://www.fda.gov/nctr/science/centers/toxicoinformatics/maqc/. Cited 29th August. 2005.
-
(2005)
-
-
-
58
-
-
0004264401
-
-
Wiley, New York, NY
-
Searle, S.R., Casella, G. and McCulloch, C.E. (1992), Variance Components, Wiley, New York, NY, p. 501.
-
(1992)
Variance Components
, pp. 501
-
-
Searle, S.R.1
Casella, G.2
McCulloch, C.E.3
-
59
-
-
84884674668
-
'Determination of safety and effectiveness'
-
FDA 21 CFR §860.7. available at Cited 1st April
-
FDA (2004), 21 CFR §860.7. 'Determination of safety and effectiveness', available at http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfcfr/CFRSearch.cfm. Cited 1st April.
-
(2004)
-
-
-
60
-
-
84884671871
-
Roche AmpliChip Cytochrome P450 Genotyping test and Affymetrix GeneChip Microarray Instrumentation System
-
FDA available at Cited 8th March
-
FDA (2005), Roche AmpliChip Cytochrome P450 Genotyping test and Affymetrix GeneChip Microarray Instrumentation System, available at http://www.fda.gov/cdrh/mda/docs/k042259.html. Cited 8th March.
-
(2005)
-
-
-
61
-
-
84884675301
-
Tag-It™ Cystic Fibrosis Kit
-
FDA available at Cited 26th August
-
FDA (2005), Tag-It™ Cystic Fibrosis Kit, available at http://www.fda.gov/cdrh/mda/docs/k043011.html. Cited 26th August.
-
(2005)
-
-
|