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1
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84942682500
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About combination products
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Web site, October 20 Accessed August 14, 2015
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U.S. Food and Drug Administration. About combination products. FDA Web site, October 20, 2009. http://www.fda.gov/CombinationProducts/AboutCombinationProducts/default.htm. Accessed August 14, 2015.
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(2009)
FDA
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2
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84942682501
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Combination product definition
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Web site, December 21 Accessed August 14, 2015
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U.S. Food and Drug Administration. Combination product definition. FDA Web site, December 21, 2011. http://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm118332.htm. Accessed August 14, 2015.
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(2011)
FDA
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3
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84942682502
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Research and markets: Drug device combination products market - Global industry analysis, size, share, growth, trends & forecast, 2013-2019 [news release]
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January 3 Accessed August 14, 2015
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Research and Markets: Drug device combination products market - global industry analysis, size, share, growth, trends & forecast, 2013-2019 [news release]. Research and Markets, January 3, 2014. http://www.businesswire.com/news/home/20140103005382/en/Research-Markets-#.VYPnryGqpBc. Accessed August 14, 2015.
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(2014)
Research and Markets
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4
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84858449673
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Lessons from innovation in drug-device combination products
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Couto, D.S., Perez-Breva L., Saraiva P., Cooney, C.L. Lessons from innovation in drug-device combination products. Adv Drug Deliv Rev 2012, 64(1): 69-77.
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(2012)
Adv Drug Deliv Rev
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Couto, D.S.1
Perez-Breva, L.2
Saraiva, P.3
Cooney, C.L.4
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5
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84942682503
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Combination products: A 40 year regulatory evolution
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Accessed August 14, 2015
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Getz, M.C., Shand, W.B, Wong, O., Garret, D.M. Combination products: A 40 year regulatory evolution. NSF 2015. http://www.nsf.org/newsroom-pdf/hs-combination-products-whitepaper.pdf. Accessed August 14, 2015.
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(2015)
NSF
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Getz, M.C.1
Shand, W.B.2
Wong, O.3
Garret, D.M.4
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7
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84942591036
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A review on comparison of regulatory requirements to approved drug device combination products in Europe and USA
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Siddharth, N., Pethani T., Sheth N.R. A review on comparison of regulatory requirements to approved drug device combination products in Europe and USA. World J Pharmacy Pharmaceut Sci 2015, 3(6): 455-75.
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(2015)
World J Pharmacy Pharmaceut Sci
, vol.3
, Issue.6
, pp. 455-475
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Siddharth, N.1
Pethani, T.2
Sheth, N.R.3
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8
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84942682505
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Office of combination products
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Web Site, February 6 Accessed August 14, 2015
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U.S. Food and Drug Administration. Office of combination products. FDA Web Site, February 6, 2015. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018184.htm. Accessed August 14, 2015.
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(2015)
FDA
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9
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84942682506
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MEDDEV. 2.1/3 rev 3: Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative - Guidelines relating to the application of the council directive 90/385/EEC on active implantable medical devices, the council directive 93/42/EEC on medical devices
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December Accessed August 14, 2015
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European Commission. MEDDEV. 2.1/3 Rev 3: Borderline Products, Drug-Delivery Products and Medical Devices incorporating, as an integral part, an Ancillary Medicinal Substance or an Ancillary Human Blood Derivative - Guidelines Relating to the Application of the Council Directive 90/385/EEC on Active Implantable Medical Devices, the Council Directive 93/42/EEC on Medical Devices. European Commission Guideline, December 2009. http://ec.europa.eu/health/medical-devices/files/meddev/2-1-3-rev-3-12-2009-en.pdf. Accessed August 14, 2015.
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(2009)
European Commission Guideline
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10
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84942682507
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Global drug device combination products market to grow at 7.9% CAGR between 2013 and 2019 [news release]
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January 13 Accessed August 14, 2015
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Global drug device combination products market to grow at 7.9% CAGR between 2013 and 2019 [news release]. Transparency Market Research, January 13, 2015. http://globenewswire.com/newsrelease/2015/01/13/697006/10115353/en/Global-DrugDevice-Combination-Products-Market-to-Grow-at-7-9CAGR-between-2013-and-2019-Transparency-Market-Research.html. Accessed August 14, 2015.
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(2015)
Transparency Market Research
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11
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84942682508
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April 1 Accessed August 14, 2015
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Sall, B.S., Lassoff, P., Babbitt, B. Getting started with a combination product Part II: European Regulations. MDDI, April 1, 2003. http://www.mddionline.com/article/getting-started-combination-productpart-ii-european-regulations. Accessed August 14, 2015.
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(2003)
Getting Started with a Combination Product Part II: European Regulations
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Sall, B.S.1
Lassoff, P.2
Babbitt, B.3
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12
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84942682509
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Combination product technology to reach $31 billion; sector attracting massive developmental companies
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October 3 Accessed August 14, 2015
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Drug Development and Delivery. Combination product technology to reach $31 billion; sector attracting massive developmental companies. Drug Development and Delivery, October 3, 2015. http://drug-dev.com/Main/Back-Issues/Combination-Product-Technology-to-Reach-31-Billion-878.aspx#sthash.99uL0VcH.dpuf. Accessed August 14, 2015.
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(2015)
Drug Development and Delivery
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13
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84942682510
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Performance report to congress
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Accessed August 14, 2015
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U.S. Food and Drug Administration. Performance report to Congress. FDA 2013. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/PerformanceReports/CombinationProducts/UCM439389.pdf. Accessed August 14, 2015.
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(2013)
FDA
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14
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84942682511
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Premarket approval (PMA)
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Web site, August 19 Accessed August 14, 2015
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U.S. Food and Drug Administration. Premarket approval (PMA). FDA Web site, August 19, 2014. http://www.fda.gov/medicaldevices/deviceregulatio-nandguidance/howtomarketyourdevice/premarketsub-missions/premarketapprovalpma/default.htm. Accessed August 14, 2015.
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(2014)
FDA
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15
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84942682512
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Premarket notification 510(k)
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Web site, July 1 Accessed August 14, 2015
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U.S. Food and Drug Administration. Premarket notification 510(k). FDA Web site, July 1, 2015. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Accessed August 14, 2015.
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(2015)
FDA
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