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In vitro diagnostics
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61	Analytical Validation and Points for Discussion Julia Tait Lathrop, PhD Immunology and Hematology Branch Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Add to Reading List Source URL: www.fda.gov Language: English Validity Science Clinical research Quality Validation Immunologic tests Proteomics Immunoassay Biomarker Medicine Pharmaceutical industry Biology
62	HIV QT Nov. 13, 2001 NucliSens HIV-1 QT NASBA Diagnostics For in vitro diagnostic use. Add to Reading List Source URL: www.fda.gov Language: English Molecular biology RNA Virology Viral load NASBA Nucleic acid test Nucleic acid Polymerase chain reaction HIV Biology HIV/AIDS Amplifiers
63	Microsoft Word - EDMA_2014-24-01_IVD_PP_FIN Add to Reading List Source URL: www.edma-ivd.eu Language: English - Date: 2014-01-24 07:42:20 Medical equipment Pharmacology Clinical research Pharmaceutical industry In vitro diagnostics Medical device IVD Global Harmonization Task Force Food and Drug Administration Medicine Health Medical technology
64	SMG 9120 FDA STAFF MANUAL GUIDES, VOLUME IV - AGENCY PROGRAM DIRECTIVES BUSINESS PRACTICES AND AGREEMENTS INTERCENTER COORDINATION OF CROSS-LABELING ACTIVITIES FOR APPROVED DRUGS/BIOLOGICS AND IN VITRO DIAGNOSTICS Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical sciences Center for Drug Evaluation and Research Biologic Center for Biologics Evaluation and Research IVD In vitro diagnostics Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
65	Microsoft Word - EDMA_2014-20-05_Clinical_evidence_briefing_FINv2 Add to Reading List Source URL: www.edma-ivd.be Language: English - Date: 2014-07-03 09:38:01 Medical equipment Science Clinical trial Design of experiments Pharmaceutical industry Pharmacology In vitro diagnostics Global Harmonization Task Force Validity Medicine Technology Medical technology
66	Strip Test, Isoniazid Classification Panel Meeting April 25, 2013 Christine King, MS, MT (ASCP) Scientific Reviewer—Chemistry and Toxicology Devices Office of In-vitro Diagnostics and Radiological Health Add to Reading List Source URL: www.fda.gov Language: English Isoniazid Latent tuberculosis Hepatitis Drug-induced lupus erythematosus Sideroblastic anemia Anion gap Tuberculosis treatment Medicine Tuberculosis Health
67	Microsoft Word - CDRH2011111 CompanionDx Final Guidance[removed]docx Add to Reading List Source URL: www.fda.gov Language: English Technology Pharmaceuticals policy Medical technology Food law United States Public Health Service Medical device Federal Food Drug and Cosmetic Act Regulatory requirement In vitro diagnostics Medicine Food and Drug Administration Health
68	Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine. Caiifornia[removed] Add to Reading List Source URL: www.fda.gov Language: English - Date: 2001-07-17 12:35:37 Bio-Rad Laboratories Medical device Food and Drug Administration In vitro Medicine Health Technology
69	Diagnostic Considerations January 8, 2014 Alberto Gutierrez Office of In Vitro Diagnostics and Add to Reading List Source URL: www.fda.gov Language: English Medical technology Pharmacology Medical statistics Clinical research Pharmaceutical industry Medical device Food and Drug Administration Clinical trial In vitro diagnostics Medicine Health Technology
70	Responsible Office/Division: Office of the Device Evaluation (ODE) Office of In Vitro Diagnostics and Radiological Health (OIR) Process Owner ODE Clinical Trials Director/OIR Chief Medical Officer Add to Reading List Source URL: www.fda.gov Language: English Research Food and Drug Administration Pharmaceutical industry Pharmacology Investigational Device Exemption Center for Devices and Radiological Health Clinical trial Medical device IDE Medicine Clinical research Pharmaceutical sciences

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