-
2
-
-
84871382725
-
-
US Department of Health and Human Services, Food and Drug Administration Fed Regist Nov 2 Accessed September 26, 2012
-
US Department of Health and Human Services, Food and Drug Administration. Authorization of emergency use of the antiviral product peramivir accompanied by emergency use information Fed Regist Nov 2, 2009;74:56644-56649. http://www.gpo.gov/fdsys/granule/FR-2009-11-02/E9-26291/content-detail.html. Accessed September 26, 2012.
-
(2009)
Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information
, vol.74
, pp. 56644-56649
-
-
-
3
-
-
73349121665
-
The emergency use authorization of peramivir for treatment of 2009 H1N1 influenza
-
Dec 3
-
Birnkrant D, Cox E. The emergency use authorization of peramivir for treatment of 2009 H1N1 influenza. N Engl J Med Dec 3, 2009;361(23):2204-2207.
-
(2009)
N Engl J Med
, vol.361
, Issue.23
, pp. 2204-2207
-
-
Birnkrant, D.1
Cox, E.2
-
4
-
-
84871370113
-
Determination and declaration regarding emergency use of anthrax vaccine adsorbed for prevention of inhalation anthrax
-
US Department of Health and Human Services
-
US Department of Health and Human Services. Determination and declaration regarding emergency use of anthrax vaccine adsorbed for prevention of inhalation anthrax. Fed Regist Feb 2, 2005;70:5450-5451.
-
(2005)
Fed Regist Feb 2
, vol.70
, pp. 5450-5451
-
-
-
5
-
-
34447292867
-
Emergency Use Authorization (EUA) to enable use of needed products in civilian and military emergencies, United States
-
Nightingale SL, Prasher JM, Simonson S. Emergency use authorization (EUA) to enable use of needed products in civilian and military emergencies, United States. Emerg Infect Dis 2007;13(7):1046-1051. (Pubitemid 47048077)
-
(2007)
Emerging Infectious Diseases
, vol.13
, Issue.7
, pp. 1046-1051
-
-
Nightingale, S.L.1
Prasher, J.M.2
Simonson, S.3
-
6
-
-
84871392723
-
Authorizations of emergency use of certain antiviral drugs-zanamivir and oseltamivir phosphate
-
US Department of Health and Human Services, Food and Drug Administration
-
US Department of Health and Human Services, Food and Drug Administration. Authorizations of emergency use of certain antiviral drugs-zanamivir and oseltamivir phosphate. Fed Regist Aug 4, 2009;74:38648-38654.
-
(2009)
Fed Regist Aug 4
, vol.74
, pp. 38648-38654
-
-
-
7
-
-
84871396585
-
Determination and declarations regarding emergency use of certain in vitro diagnostic, antiviral, and personal respiratory products accompanied by emergency use information
-
US Department of Health and Human Services
-
US Department of Health and Human Services. Determination and declarations regarding emergency use of certain in vitro diagnostic, antiviral, and personal respiratory products accompanied by emergency use information. Fed Regist Aug 4, 2009;74:38628-38630.
-
(2009)
Fed Regist Aug 4
, vol.74
, pp. 38628-38630
-
-
-
8
-
-
70350164875
-
Emergency use authority and 2009 H1N1 influenza
-
Sherman SE, Foster J, Vaid S. Emergency use authority and 2009 H1N1 influenza. Biosecur Bioterror 2009;7(3):245-250.
-
(2009)
Biosecur Bioterror
, vol.7
, Issue.3
, pp. 245-250
-
-
Sherman, S.E.1
Foster, J.2
Vaid, S.3
-
9
-
-
84871361659
-
The novel influenza task force, headed by Japanese Prime Minister
-
[in Japanese] October 1
-
The Novel Influenza Task Force, headed by Japanese Prime Minister. Basic policies on how to deal with novel influenza [in Japanese]. October 1, 2009.
-
(2009)
Basic Policies on How to Deal with Novel Influenza
-
-
-
10
-
-
82755192487
-
Oseltamivir prescription and regulatory actions vis-A-vis abnormal behavior risk in Japan: Drug utilization study using a nationwide pharmacy database
-
Urushihara H, Doi Y, Arai M, et al. Oseltamivir prescription and regulatory actions vis-a-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database. PLoS ONE 2011;6(12):e28483.
-
(2011)
PLoS ONE
, vol.6
, Issue.12
-
-
Urushihara, H.1
Doi, Y.2
Arai, M.3
-
11
-
-
84871380400
-
The novel influenza task force, headed by Japanese prime minister
-
[in Japanese] October 1
-
The Novel Influenza Task Force, headed by Japanese Prime Minister. Basic policy of vaccination for novel influenza A/H1N1 [in Japanese]. October 1, 2009.
-
(2009)
Basic Policy of Vaccination for Novel Influenza A/H1N1
-
-
-
12
-
-
84871398461
-
-
Pharmaceutical Affairs Law Final revisions Tokyo: Government of Japan; June 21
-
Pharmaceutical Affairs Law. Law No. 145 of 1960. Final revisions. Tokyo: Government of Japan; June 21, 2006.
-
(2006)
Law 145 of 1960
-
-
-
14
-
-
84871368664
-
-
Ministry of Health Labour and Welfare Health Crisis Management [in Japanese] Tokyo: Ministry of Health, Labour and Welfare
-
Ministry of Health, Labour and Welfare Health Crisis Management. Basic guidelines [in Japanese]. Tokyo: Ministry of Health, Labour and Welfare; 1997.
-
(1997)
Basic Guidelines
-
-
-
15
-
-
84871367196
-
-
[in Japanese] February 2009 amendment ed: Conference of relevant ministries and agencies on countermeasures to novel and avian influenza
-
The action program for countermeasures to novel influenza [in Japanese]. February 2009 amendment ed: Conference of relevant ministries and agencies on countermeasures to novel and avian influenza; 2009.
-
(2009)
The Action Program for Countermeasures to Novel Influenza
-
-
-
16
-
-
28644436967
-
-
Department of Communicable Disease, Surveillance and Response, Global Influenza Programme Geneva World Health Organization
-
Department of Communicable Disease, Surveillance and Response, Global Influenza Programme. WHO global influenza preparedness plan. Geneva: World Health Organization; 2005.
-
(2005)
WHO Global Influenza Preparedness Plan
-
-
-
17
-
-
84871393672
-
Countermeasures for infectious diseases and vaccine administration [in Japanese]
-
Kawakami K. Countermeasures for infectious diseases and vaccine administration [in Japanese]. Pharmacia 2008;44(7): 693-696.
-
(2008)
Pharmacia
, vol.44
, Issue.7
, pp. 693-696
-
-
Kawakami, K.1
-
18
-
-
58149257955
-
-
US Food Drug Administration Office of Counterterrorism Policy and Planning Accessed October 1,2012
-
US Food and Drug Administration, Office of Counterterrorism Policy and Planning. Guidance-Emergency Use Authorization ofMedical Products. 2007. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm. Accessed October 1, 2012.
-
(2007)
Guidance-Emergency Use Authorization OfMedical Products
-
-
-
19
-
-
70350468697
-
Federal declaration of a public health emergency
-
Ray J. Federal declaration of a public health emergency. Biosecur Bioterror 2009;7(3):251-258.
-
(2009)
Biosecur Bioterror
, vol.7
, Issue.3
, pp. 251-258
-
-
Ray, J.1
-
24
-
-
79953766801
-
Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an emergency IND program in the United States
-
Mar 15
-
Hernandez JE, Adiga R, Armstrong R, et al. Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an emergency IND program in the United States. Clin Infect Dis Mar 15 2011;52(6):695-706.
-
(2011)
Clin Infect Dis
, vol.52
, Issue.6
, pp. 695-706
-
-
Hernandez, J.E.1
Adiga, R.2
Armstrong, R.3
-
25
-
-
70149104075
-
Expanded access to investigational drugs for treatment use 21 CFR 312, 21 CFR 316
-
US Department of Health and Human Services, Food and Drug Administration
-
US Department of Health and Human Services, Food and Drug Administration. Expanded access to investigational drugs for treatment use. 21 CFR 312, 21 CFR 316. Fed Regist Aug 13, 2009;74:40900-40945.
-
(2009)
Fed Regist Aug 13
, vol.74
, pp. 40900-40945
-
-
-
33
-
-
77958476873
-
The role of clinical pharmacology in supporting the emergency use authorization of an unapproved anti-influenza drug peramivir
-
Arya V, Carter WW, Robertson SM. The role of clinical pharmacology in supporting the emergency use authorization of an unapproved anti-influenza drug, peramivir. Clin Pharmacol Ther 2010;88(5):587-589.
-
(2010)
Clin Pharmacol Ther
, vol.88
, Issue.5
, pp. 587-589
-
-
Arya, V.1
Carter, W.W.2
Robertson, S.M.3
-
34
-
-
84871371101
-
-
(Feburary 22, 2010) [in Japanese] Tokyo: Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour, and Welfare
-
Results of public comment on emergency approval of imported novel influenza vaccines (Feburary 22, 2010) [in Japanese]. Tokyo: Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour, and Welfare; 2010.
-
(2010)
Results of Public Comment on Emergency Approval of Imported Novel Influenza Vaccines
-
-
-
37
-
-
78951473885
-
The emergency use authorization of peramivir IV: A view from the manufacturer
-
Hollister AS, Sheridan WP. The emergency use authorization of peramivir IV: a view from the manufacturer. Clin Pharmacol Ther 2011;89(2):172-174.
-
(2011)
Clin Pharmacol Ther
, vol.89
, Issue.2
, pp. 172-174
-
-
Hollister, A.S.1
Sheridan, W.P.2
-
38
-
-
84871379805
-
BioCryst: Israel orders 150 doses of H1N1 antiviral peramivir
-
December 21 Accessed April 27, 2012
-
Murphy M. BioCryst: Israel orders 150 doses of H1N1 antiviral peramivir. Seeking Alpha December 21, 2009. http://seekingalpha.com/article/179144- biocryst-israel-orders-150-doses-of-h1n1-antiviral-peramivir. Accessed April 27, 2012.
-
(2009)
Seeking Alpha
-
-
Murphy, M.1
-
40
-
-
84862183539
-
Peramivir use for treatment of hospitalized patients with influenza A(H1N1)pdm09 under emergency use authorization October 2009-June 2010
-
Jul
-
Yu Y, Garg S, Yu PA, et al. Peramivir use for treatment of hospitalized patients with influenza A(H1N1)pdm09 under emergency use authorization, October 2009-June 2010. Clin Infect Dis 2012 Jul;55(1):8-15.
-
(2012)
Clin Infect Dis
, vol.55
, Issue.1
, pp. 8-15
-
-
Yu, Y.1
Garg, S.2
Yu, P.A.3
-
42
-
-
84871376104
-
-
4th Investigation Committee of Safety Measurements (August 25, 2010) [in Japanese]. Tokyo: Subcommittee on Safety Measurement, Committee of Safety of Drugs, Pharmaceutical Affairs and Food Sanitation Council, Ministry of Health, Labour and Welfare
-
Number of people vaccinated and reporting frequencies of adverse reactions. 4th Investigation Committee of Safety Measurements (August 25, 2010) [in Japanese]. Tokyo: Subcommittee on Safety Measurement, Committee of Safety of Drugs, Pharmaceutical Affairs and Food Sanitation Council, Ministry of Health, Labour and Welfare; 2010.
-
(2010)
Number of People Vaccinated and Reporting Frequencies of Adverse Reactions
-
-
-
43
-
-
84871363399
-
Termination of declarations justifying emergency use authorizations of certain in vitro diagnostic devices, antiviral drugs, and personal respiratory protection devices
-
Hamburg M. Termination of declarations justifying emergency use authorizations of certain in vitro diagnostic devices, antiviral drugs, and personal respiratory protection devices. Fed Regist June 25, 2010;75:36432-36435.
-
(2010)
Fed Regist June 25
, vol.75
, pp. 36432-36435
-
-
Hamburg, M.1
-
44
-
-
84871399634
-
-
ClinicalTrials.gov 2011 Accessed November 29, 2011
-
US National Institutes of Health. ClinicalTrials.gov 2011. http://clinicaltrials.gov/ct2/home. AccessedNovember 29, 2011.
-
US National Institutes of Health
-
-
-
47
-
-
80054709041
-
Phase III randomized double-blind study comparing single-dose intravenous peramivir with oral oseltamivir in patients with seasonal influenza virus infection
-
Nov
-
Kohno S, Yen MY, Cheong HJ, et al. Phase III randomized, double-blind study comparing single-dose intravenous peramivir with oral oseltamivir in patients with seasonal influenza virus infection. Antimicrob Agents Chemother 2011 Nov;55(11):5267-5276.
-
(2011)
Antimicrob Agents Chemother
, vol.55
, Issue.11
, pp. 5267-5276
-
-
Kohno, S.1
Yen, M.Y.2
Cheong, H.J.3
-
49
-
-
84871364182
-
-
The Novel Influenza Task Force, Japanese Association of Infectious Diseases [in Japanese]. Tokyo: Japanese Association of Infectious Diseases; December 3
-
The Novel Influenza Task Force, Japanese Association of Infectious Diseases. Review of year of 2010 and point of view on 2010/2011 season [in Japanese]. Tokyo: Japanese Association of Infectious Diseases; December 3, 2010.
-
(2010)
Review of Year of 2010 and Point of View on 2010/2011 Season
-
-
-
50
-
-
80052935987
-
Very low pandemic influenza A (H1N1 2009 mortality associated with early neuraminidase inhibitor treatment in Japan: Analysis of 1000 hospitalized children
-
Oct
-
Sugaya N, Shinjoh M, Mitamura K, Takahashi T. Very low pandemic influenza A (H1N1) 2009 mortality associated with early neuraminidase inhibitor treatment in Japan: analysis of 1000 hospitalized children. J Infect 2011 Oct; 63(4):288-294.
-
(2011)
J Infect
, vol.63
, Issue.4
, pp. 288-294
-
-
Sugaya, N.1
Shinjoh, M.2
Mitamura, K.3
Takahashi, T.4
-
52
-
-
70350139980
-
Public willingness to take a vaccine or drug under emergency use authorization during the 2009 H1N1 pandemic
-
Quinn SC, Kumar S, Freimuth VS, Kidwell K, Musa D. Public willingness to take a vaccine or drug under emergency use authorization during the 2009 H1N1 pandemic. Biosecur Bioterror 2009;7(3):275-290.
-
(2009)
Biosecur Bioterror
, vol.7
, Issue.3
, pp. 275-290
-
-
Quinn, S.C.1
Kumar, S.2
Freimuth, V.S.3
Kidwell, K.4
Musa, D.5
-
53
-
-
50149093837
-
Overview of the clinical application of regenerative medicine products in Japan
-
Oct
-
Tsubouchi M, Matsui S, Banno Y, Kurokawa K, Kawakami K. Overview of the clinical application of regenerative medicine products in Japan. Health Policy 2008 Oct;88(1):62-72.
-
(2008)
Health Policy
, vol.88
, Issue.1
, pp. 62-72
-
-
Tsubouchi, M.1
Matsui, S.2
Banno, Y.3
Kurokawa, K.4
Kawakami, K.5
-
54
-
-
84862164072
-
Editorial commentary: What did we learn from the emergency use authorization of peramivir in 2009?
-
Jul
-
Pavia AT. Editorial commentary: what did we learn from the emergency use authorization of peramivir in 2009? Clin Infect Dis 2012 Jul;55(1):16-18.
-
(2012)
Clin Infect Dis
, vol.55
, Issue.1
, pp. 16-18
-
-
Pavia, A.T.1
-
55
-
-
84857227370
-
Evidence vs. access: Can twenty-first-century drug regulation refine the tradeoffs?
-
Mar
-
Woodcock J. Evidence vs. access: can twenty-first-century drug regulation refine the tradeoffs? Clin Pharmacol Ther 2012 Mar;91(3):378-380.
-
(2012)
Clin Pharmacol Ther
, vol.91
, Issue.3
, pp. 378-380
-
-
Woodcock, J.1
-
56
-
-
84862777400
-
Adaptive licensing: Taking the next step in the evolution of drug approval
-
Mar
-
Eichler HG, Oye K, Baird LG, et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin Pharmacol Ther 2012 Mar;91(3):426-437.
-
(2012)
Clin Pharmacol Ther
, vol.91
, Issue.3
, pp. 426-437
-
-
Eichler, H.G.1
Oye, K.2
Baird, L.G.3
|