ARTICLE;
DEATH;
DISEASE COURSE;
DRUG EFFECT;
DRUG MARKETING;
EBOLA VIRUS;
EMERGENCY HEALTH SERVICE;
EPIDEMIC;
ETHICS;
FOOD AND DRUG ADMINISTRATION;
HEALTH CARE ACCESS;
HEALTH CARE QUALITY;
HEALTH CARE SYSTEM;
HUMAN;
INFECTION CONTROL;
INFLUENZA VIRUS A H1N1;
INTERVENTION STUDY;
NONHUMAN;
PHASE 1 CLINICAL TRIAL (TOPIC);
PUBLIC HEALTH;
REAL TIME POLYMERASE CHAIN REACTION;
REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION;
WESTERN MEDICINE;
ALTRUISM;
EBOLAVIRUS;
EMERGENCY;
EXPERIMENTAL THERAPY;
HEALTH;
HEMORRHAGIC FEVER, EBOLA;
INTERNATIONAL COOPERATION;
RELIEF WORK;
VIROLOGY;
ALTRUISM;
EBOLAVIRUS;
EMERGENCIES;
EPIDEMICS;
GLOBAL HEALTH;
HEMORRHAGIC FEVER, EBOLA;
HUMANS;
INTERNATIONAL COOPERATION;
PUBLIC HEALTH;
RELIEF WORK;
THERAPIES, INVESTIGATIONAL;
World Health Organisation (2014) WHO Statement on the Meeting of the International Health Regulations Emergency Committee Regarding the 2014 Ebola Outbreak in West Africa. http://www.who.int/mediacentre/news/statements/2014/ebola-20140808/en/. Accessed 01 September 2014.
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US Centres for Disease Control (2014) Questions and Answers on Experimental Treatments and Vaccines for Ebola. http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimental-treatments.html. Accessed 01 September 2014.
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World Health Organisation (2014) Ethical considerations for use of unregistered interventions for Ebola virus disease (EVD). Summary of the panel discussion. http://www.who.int/mediacentre/news/statements/2014/ebola-ethical-review-summary/en/. Accessed 01 September 2014.
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Hamburg M (2014) FDA as part of a coordinated global response on Ebola. http://blogs.fda.gov/fdavoice/index.php/2014/10/fda-as-part-of-a-coordinated-global-response-on-ebola/#sthash.8MePlWDX.dpuf. Accessed 07 November 2014.
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US FDA (2014) 21 CFR 56.102(d) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.102. Accessed 01 September 2014.
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US FDA (2014) 21 CFR, Sec. 312.23 or Sec. 312.34. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312. Accessed 01 September 2014.
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US FDA (2014) 21 CFR 56.104(c). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.104. Accessed 01 September 2014.
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Dennis B, Bernstein L (2014) Two Americans who contracted Ebola in Africa received an experimental serum. http://www.washingtonpost.com/national/health-science/2014/08/04/dbc44a48-1c07-11e4-ae54-0cfe1f974f8a_story.html. Accessed 01 September 2014.
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US FDA (2010) Amended Authorizations of Emergency Use of Certain Antiviral Drugs Zanamivir and Oseltamivir Phosphate; Availability. A Notice by the Food and Drug Administration on 04/19/2010. https://www.federalregister.gov/articles/2010/04/19/2010-8603/amended-authorizations-of-emergency-use-of-certain-antiviral-drugs-zanamivir-and-oseltamivir#h-10. Accessed 01 September 2014.
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US FDA (2005) Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax. A Notice by the Food and Drug Administration on 02/02/2005. https://www.federalregister.gov/articles/2005/02/02/05-2028/authorization-of-emergency-use-of-anthrax-vaccine-adsorbed-for-prevention-of-inhalation-anthrax-by. Accessed 01 September 2014.
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US FDA (2014) Emergency Situations (Medical Devices). http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm#h7n9. Accessed 01 September 2014.
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US Health and Human Services Department (2014) Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus. https://www.federalregister.gov/articles/2014/08/12/2014-19026/declaration-regarding-emergency-use-of-in-vitro-diagnostics-for-detection-of-ebola-virus. Accessed 01 September 2014.
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FDA, Off-label use, and informed consent: debunking myths and misconceptions
Beck JM, Azari ED, (1998) FDA, Off-label use, and informed consent: debunking myths and misconceptions. Food and Drug Law Journal 53: 71–104. 11795338
Fedson DS, Opalaug SM (2014) Can Statins Help Treat Ebola? http://www.nytimes.com/2014/08/16/opinion/can-statins-help-treat-ebola.html?_r=0. Accessed 01 September 2014.
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Kaneko K, Uetake T (2014) Japan could offer unapproved Ebola drug. http://www.reuters.com/article/2014/08/25/us-health-ebola-japan-idUSKBN0GP05X20140825. Accessed 01 September 2014.
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Reuters (2014) First French Ebola patient leaves hospital. http://www.reuters.com/article/2014/10/04/us-health-ebola-france-idUSKCN0HT0D720141004. Accessed 01 September 2014
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US FDA (2014) 21 CFR 312.42. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312. Accessed 01 September 2014.
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Tekmira (2011) Tekmira Pharmaceuticals Receives Approval from FDA to Initiate TKM-Ebola Phase 1 Clinical Trial. http://investor.tekmirapharm.com/releasedetail.cfm?ReleaseID=627019. Accessed 01 September 2014.
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CBC News (2014) B.C.’s Tekmira gets FDA approval to fast track Ebola drug. http://www.cbc.ca/news/business/b-c-s-tekmira-gets-fda-approval-to-fast-track-ebola-drug-1.2731250. Accessed 01 September 2014.
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Tekmira (2014) FDA Modifies Tekmira’s TKM-Ebola Clinical Hold to Partial Hold enabling use of Tekmira’s investigational therapeutic in Ebola-Infected patients. http://investor.tekmirapharm.com/releasedetail.cfm?ReleaseID=865208. Accessed 01 September 2014.
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Globe Newswire (2014) BioCryst Receives Additional NIAID Funding to Conduct a Non-Human Primate Study of BCX4430 in Ebola Virus Disease. http://investor.shareholder.com/biocryst/ReleaseDetail.cfm?ReleaseID=868302. Accessed 01 September 2014.
* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.