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Volumn 174, Issue 1, 2014, Pages 90-95

Development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US food and drug administration the class of 2008

Author keywords

[No Author keywords available]

Indexed keywords

17 METHYLNALTREXONE; ALVIMOPAN; BENDAMUSTINE; CARCINOGEN; CERTOLIZUMAB PEGOL; CLEVIDIPINE; DEGARELIX; DESVENLAFAXINE; DIFLUPREDNATE; ELTROMBOPAG; ETRAVIRINE; FESOTERODINE; FOSPROPOFOL; HARKOSERIDE; MUTAGENIC AGENT; PLERIXAFOR; PRESTIQ; RILONACEPT; ROMIPLOSTIM; RUFINAMIDE; SILODOSIN; TAPENTADOL; TERATOGENIC AGENT; TETRABENAZINE; UNCLASSIFIED DRUG; VENLAFAXINE;

EID: 84892390898     PISSN: 21686106     EISSN: None     Source Type: Journal    
DOI: 10.1001/jamainternmed.2013.11813     Document Type: Article
Times cited : (75)

References (17)
  • 1
    • 84892425670 scopus 로고    scopus 로고
    • 21 USC §355 Accessed April 22, 2013
    • 21 USC §355. New drugs. www.gpo.gov/fdsys/pkg/USCODE-2010-title21/ html/USCODE-2010-title21-chap9-subchapV-partA-sec355.htm. Accessed April 22, 2013.
    • New Drugs
  • 5
    • 84892375676 scopus 로고    scopus 로고
    • 21 USC §355c Accessed September 20, 2013
    • 21 USC §355c. Research into pediatric uses for drugs and biological products. www.gpo.gov/fdsys/pkg/USCODE-2012-title21/pdf/USCODE-2012-title21- chap9-subchapV-partA-sec355c.pdf. Accessed September 20, 2013.
    • Research into Pediatric Uses for Drugs and Biological Products
  • 6
    • 79953076105 scopus 로고    scopus 로고
    • 21 USC §355-1 Accessed September 20, 2013
    • 21 USC §355-1. Risk evaluation and mitigation strategies. www.gpo.gov/fdsys/pkg/USCODE-2012-title21/pdf/USCODE-2012-title21-chap9- subchapV-partA-sec355-1.pdf. Accessed September 20, 2013.
    • Risk Evaluation and Mitigation Strategies
  • 7
    • 84875367623 scopus 로고    scopus 로고
    • President's Council of Advisors on Science and Technology Washington, DC: Executive Office of the President of the United States; September 1
    • President's Council of Advisors on Science and Technology. Report to the President on Propelling Innovation in Drug Discovery, Development and Evaluation. Washington, DC: Executive Office of the President of the United States; September 1, 2012.
    • (2012) Report to the President on Propelling Innovation in Drug Discovery, Development and Evaluation
  • 9
    • 84892420120 scopus 로고    scopus 로고
    • Creating an alternative approval pathway for certain drugs intended to address unmet need
    • Accessed August 27, 2013
    • Creating an alternative approval pathway for certain drugs intended to address unmet need. Fed Regist. 2013;78(10):3005-3008. www.gpo.gov/fdsys/pkg/FR- 2013-01-15/pdf/2013-00607.pdf. Accessed August 27, 2013.
    • (2013) Fed Regist. , vol.78 , Issue.10 , pp. 3005-3008
  • 12
    • 84855685310 scopus 로고    scopus 로고
    • US Food and Drug Administration Accessed April 23, 2013
    • US Food and Drug Administration. Drug approvals and databases. www.fda.gov/Drugs/InformationOnDrugs/default.htm. Accessed April 23, 2013.
    • Drug Approvals and Databases
  • 13
    • 79959690009 scopus 로고    scopus 로고
    • US National Library of Medicine website Accessed April 23, 2013
    • Daily Med Current Medication Information. US National Library of Medicine website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Accessed April 23, 2013.
    • Daily Med Current Medication Information
  • 15
    • 84881776943 scopus 로고    scopus 로고
    • 21 USC §360cc Accessed August 27, 2013
    • 21 USC §360cc. Protection for drugs for rare diseases or conditions. www.gpo.gov/fdsys/pkg/USCODE-2011-title21/pdf/USCODE-2011-title21-chap9- subchapV-partB-sec360cc.pdf. Accessed August 27, 2013.
    • Protection for Drugs for Rare Diseases or Conditions


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.