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Volumn 51, Issue 8, 2015, Pages 505-513

Drug-device combination products: Regulatory landscape and market growth

Author keywords

Combination product; Drug device combination; Medical device; Regulatory

Indexed keywords

BIOLOGICAL PRODUCT; CETUXIMAB; DABRAFENIB; EVEROLIMUS; OLAPARIB; PACLITAXEL; TRASTUZUMAB; ZOTAROLIMUS;

EID: 84942599044     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2015.51.8.2376223     Document Type: Review
Times cited : (11)

References (15)
  • 1
    • 84942682500 scopus 로고    scopus 로고
    • About combination products
    • Web site, October 20 Accessed August 14, 2015
    • 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.
    • (2009) FDA
  • 2
    • 84942682501 scopus 로고    scopus 로고
    • Combination product definition
    • Web site, December 21 Accessed August 14, 2015
    • 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.
    • (2011) FDA
  • 3
    • 84942682502 scopus 로고    scopus 로고
    • Research and markets: Drug device combination products market - Global industry analysis, size, share, growth, trends & forecast, 2013-2019 [news release]
    • January 3 Accessed August 14, 2015
    • 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.
    • (2014) Research and Markets
  • 5
    • 84942682503 scopus 로고    scopus 로고
    • Combination products: A 40 year regulatory evolution
    • Accessed August 14, 2015
    • 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.
    • (2015) NSF
    • Getz, M.C.1    Shand, W.B.2    Wong, O.3    Garret, D.M.4
  • 7
    • 84942591036 scopus 로고    scopus 로고
    • A review on comparison of regulatory requirements to approved drug device combination products in Europe and USA
    • 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.
    • (2015) World J Pharmacy Pharmaceut Sci , vol.3 , Issue.6 , pp. 455-475
    • Siddharth, N.1    Pethani, T.2    Sheth, N.R.3
  • 8
    • 84942682505 scopus 로고    scopus 로고
    • Office of combination products
    • Web Site, February 6 Accessed August 14, 2015
    • 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.
    • (2015) FDA
  • 9
    • 84942682506 scopus 로고    scopus 로고
    • 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
    • December Accessed August 14, 2015
    • 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.
    • (2009) European Commission Guideline
  • 10
    • 84942682507 scopus 로고    scopus 로고
    • Global drug device combination products market to grow at 7.9% CAGR between 2013 and 2019 [news release]
    • January 13 Accessed August 14, 2015
    • 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.
    • (2015) Transparency Market Research
  • 12
    • 84942682509 scopus 로고    scopus 로고
    • Combination product technology to reach $31 billion; sector attracting massive developmental companies
    • October 3 Accessed August 14, 2015
    • 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.
    • (2015) Drug Development and Delivery
  • 13
    • 84942682510 scopus 로고    scopus 로고
    • Performance report to congress
    • Accessed August 14, 2015
    • 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.
    • (2013) FDA
  • 14
    • 84942682511 scopus 로고    scopus 로고
    • Premarket approval (PMA)
    • Web site, August 19 Accessed August 14, 2015
    • 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.
    • (2014) FDA
  • 15
    • 84942682512 scopus 로고    scopus 로고
    • Premarket notification 510(k)
    • Web site, July 1 Accessed August 14, 2015
    • 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.
    • (2015) FDA


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.