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Volumn 174, Issue 9, 2014, Pages 1436-1437

The potential risks of expedited approval of drugs for acute bacterial infections

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; COLISTIN; DALBAVANCIN; DRUG; LINEZOLID; RIFAMPICIN; SULFANILAMIDE DERIVATIVE; TEDIZOLID; TELAVANCIN; VANCOMYCIN; ANTIINFECTIVE AGENT;

EID: 84907015244     PISSN: 21686106     EISSN: 21686114     Source Type: Journal    
DOI: 10.1001/jamainternmed.2014.3055     Document Type: Note
Times cited : (5)

References (9)
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    • US Food Drug Administration. Guidance for industry. Accessed May 14
    • US Food and Drug Administration. Guidance for industry. http://www.fda.gov/downloads/Drugs/guidancecomplianceregulatoryinformation/Guidances/UCM359184.pdf. Accessed May 14, 2014.
    • (2014)
  • 2
    • 84907014190 scopus 로고    scopus 로고
    • US Food Drug Administration. Guidance for industry. Accessed May 14
    • US Food and Drug Administration. Guidance for industry. http://www.fda.gov/downloads/Drugs/guidancecomplianceregulatoryinformation/Guidances/UCM358301.pdf. Accessed May 14, 2014.
    • (2014)
  • 3
    • 0030268577 scopus 로고    scopus 로고
    • Surrogate end points in clinical trials
    • Fleming TR, DeMets DL. Surrogate end points in clinical trials. Ann Intern Med. 1996;125(7):605-613.
    • (1996) Ann Intern Med. , vol.125 , Issue.7 , pp. 605-613
    • Fleming, T.R.1    De Mets, D.L.2
  • 4
    • 84907008786 scopus 로고    scopus 로고
    • US Food Drug Administration.Guidance for industry. Accessed May 14
    • US Food and Drug Administration. Guidance for industry. http://www.fda.gov/downloads/Drugs/guidancecomplianceregulatoryinformation/Guidances/UCM234907.pdf. AccessedMay 14, 2014.
    • (2014)
  • 5
    • 84907013814 scopus 로고    scopus 로고
    • US Food Drug Administration. November 29, 2012 Accessed May 14
    • US Food and Drug Administration. November 29, 2012 meeting of the Anti-Infective Drugs Advisory Committee. http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/Drugs/Anti-infectivedrugsadvisorycommittee/ucm293600.htm. Accessed May 14, 2014.
    • (2014) Meeting of the Anti-Infective Drugs Advisory Committee
  • 6
    • 84907013814 scopus 로고    scopus 로고
    • US Food Drug Administration. March 31, 2014 Accessed May 14
    • US Food and Drug Administration. March 31, 2014 meeting of the Anti-Infective Drugs Advisory Committee. http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/Drugs/Anti-infectivedrugsadvisorycommittee/ucm385739.htm. Accessed May 14, 2014.
    • (2014) Meeting of the Anti-Infective Drugs Advisory Committee
  • 7
    • 84866648642 scopus 로고    scopus 로고
    • Progress on developing end points for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
    • Talbot GH, Powers JH, Fleming TR, Siuciak JA, Bradley J, Boucher H. Progress on developing end points for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Clin Infect Dis. 2012;55(8):1114-1121.
    • (2012) Clin Infect Dis. , vol.55 , Issue.8 , pp. 1114-1121
    • Talbot, G.H.1    Powers, J.H.2    Fleming, T.R.3    Siuciak, J.A.4    Bradley, J.5    Boucher, H.6
  • 8
    • 78349262667 scopus 로고    scopus 로고
    • Accelerated approval and possible withdrawal of midodrine
    • Dhruva SS, Redberg RF. Accelerated approval and possible withdrawal of midodrine. JAMA. 2010; 304(19):2172-2173.
    • (2010) JAMA , vol.304 , Issue.19 , pp. 2172-2173
    • Dhruva, S.S.1    Redberg, R.F.2
  • 9
    • 84880379313 scopus 로고    scopus 로고
    • Colistin and rifampicin compared with colistin alone for the treatment of serious infections due to extensively drug-resistant Acinetobacter baumannii: A multicenter, randomized clinical trial
    • Durante-Mangoni E, Signoriello G, Andini R, et al. Colistin and rifampicin compared with colistin alone for the treatment of serious infections due to extensively drug-resistant Acinetobacter baumannii: a multicenter, randomized clinical trial. Clin Infect Dis. 2013;57(3):349-358.
    • (2013) Clin Infect Dis. , vol.57 , Issue.3 , pp. 349-358
    • Durante-Mangoni, E.1    Signoriello, G.2    Andini, R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.