-
1
-
-
84873069274
-
-
US Food and Drug Administration Accessed June 17, 2009
-
US Food and Drug Administration. What we do. http://www.fda.gov/AboutFDA/WhatWeDo/default.htm Accessed June 17, 2009
-
What we do
-
-
-
2
-
-
68649126478
-
-
US Food and Drug Administration Accessed June 17, 2009
-
US Food and Drug Administration. Legislation. http://www.fda.gov/RegulatoryInformation/Legislation/default.htm Accessed June 17, 2009
-
Legislation
-
-
-
3
-
-
26444588297
-
-
European Medicines Agency (EMEA) Accessed February 9, 2009
-
European Medicines Agency (EMEA). About EMEA-structure. http://www.emea.europa.eu/htms/aboutus/emeaoverview.htm Accessed February 9, 2009
-
About EMEA-structure
-
-
-
4
-
-
68649105645
-
-
European Directorate for the Quality of Medicines & HealthCare Accessed June 17, 2009
-
European Directorate for the Quality of Medicines & HealthCare. About the EDQM, its vision & mission. http://www.edqm.eu/en/About-the-EDQM-amp-its-Missions-604.html Accessed June 17, 2009
-
About the EDQM, its vision & mission
-
-
-
5
-
-
39449103059
-
The epidemic of antibiotic-resistant infections: A call to action for the medical community from the Infectious Diseases Society of America
-
the Infectious Diseases Society of America
-
Spellberg B., Guidos R., Gilbert D., et al., the Infectious Diseases Society of America. The epidemic of antibiotic-resistant infections: A call to action for the medical community from the Infectious Diseases Society of America. Clin Infect Dis. 46 (2008) 155-164
-
(2008)
Clin Infect Dis.
, vol.46
, pp. 155-164
-
-
Spellberg, B.1
Guidos, R.2
Gilbert, D.3
-
6
-
-
40749097343
-
Trials and tribulations of antibiotic development
-
Trials and tribulations of antibiotic development. Lancet Infect Dis. 8 (2008) 209
-
(2008)
Lancet Infect Dis.
, vol.8
, pp. 209
-
-
-
7
-
-
68649106109
-
Pneumonia workshop raises more questions than answers
-
Tillotson G. Pneumonia workshop raises more questions than answers. Lancet Infect Dis. 8 (2008) 221
-
(2008)
Lancet Infect Dis.
, vol.8
, pp. 221
-
-
Tillotson, G.1
-
8
-
-
0034680096
-
Changing patterns of infectious disease
-
Cohen M.L. Changing patterns of infectious disease. Nature. 406 (2000) 762-767
-
(2000)
Nature.
, vol.406
, pp. 762-767
-
-
Cohen, M.L.1
-
9
-
-
34250828630
-
The record on rosiglitazone and the risk of myocardial infarction
-
Psaty B.M., and Furberg C.D. The record on rosiglitazone and the risk of myocardial infarction. N Engl J Med. 357 (2007) 67-69
-
(2007)
N Engl J Med.
, vol.357
, pp. 67-69
-
-
Psaty, B.M.1
Furberg, C.D.2
-
10
-
-
40549101273
-
-
US Food and Drug Administration (FDA) Accessed February 9, 2009
-
US Food and Drug Administration (FDA). Drug information. http://www.fda.gov/cder/drug/default.htm Accessed February 9, 2009
-
Drug information
-
-
-
11
-
-
34848884841
-
How bacteraemia is reviewed by medicines licensing authorities in Europe
-
Toivonen M. How bacteraemia is reviewed by medicines licensing authorities in Europe. Int J Antimicrob Agents. 30 Suppl 1 (2007) S103-S107
-
(2007)
Int J Antimicrob Agents.
, vol.30
, Issue.SUPPL. 1
-
-
Toivonen, M.1
-
12
-
-
29544447648
-
Technology licensing: Lessons from the US experience
-
Sobolski G.K., Barton J.H., and Emanuel E.J. Technology licensing: Lessons from the US experience. JAMA. 294 (2005) 3137-3140
-
(2005)
JAMA.
, vol.294
, pp. 3137-3140
-
-
Sobolski, G.K.1
Barton, J.H.2
Emanuel, E.J.3
-
13
-
-
21544464575
-
Differences in product information of biopharmaceuticals in the EU and the USA: Implications for product development
-
Nieminen O., Kurki P., and Nordström K. Differences in product information of biopharmaceuticals in the EU and the USA: Implications for product development. Eur J Pharm Biopharm. 60 (2005) 319-326
-
(2005)
Eur J Pharm Biopharm.
, vol.60
, pp. 319-326
-
-
Nieminen, O.1
Kurki, P.2
Nordström, K.3
-
14
-
-
1642320280
-
The US and European regulatory systems: A comparison
-
Redmond K. The US and European regulatory systems: A comparison. J Ambul Care Manage. 27 (2004) 105-114
-
(2004)
J Ambul Care Manage.
, vol.27
, pp. 105-114
-
-
Redmond, K.1
-
15
-
-
68649104421
-
-
US FDA's non-inferiority stance could slow sinusitis approvals
-
US FDA's non-inferiority stance could slow sinusitis approvals. SCRIP World Pharmaceutical News (Sept 18, 2006) 27
-
(2006)
SCRIP World Pharmaceutical News
, pp. 27
-
-
-
16
-
-
0141925815
-
Staphylococcus aureus bacteremia: Recurrence and the impact of antibiotic treatment in a prospective multicenter study
-
Chang F.Y., Peacock Jr. J.E., Musher D.M., et al. Staphylococcus aureus bacteremia: Recurrence and the impact of antibiotic treatment in a prospective multicenter study. Medicine (Baltimore). 82 (2005) 333-339
-
(2005)
Medicine (Baltimore).
, vol.82
, pp. 333-339
-
-
Chang, F.Y.1
Peacock Jr., J.E.2
Musher, D.M.3
-
17
-
-
0348230324
-
Staphylococcus aureus bacte-remia: Compliance with standard treatment, long-term outcome and predictors of relapse
-
Johnson L.B., Almoujahed M.O., Ilg K., et al. Staphylococcus aureus bacte-remia: Compliance with standard treatment, long-term outcome and predictors of relapse. Scand J Infect Dis. 35 (2003) 782-789
-
(2003)
Scand J Infect Dis.
, vol.35
, pp. 782-789
-
-
Johnson, L.B.1
Almoujahed, M.O.2
Ilg, K.3
-
21
-
-
68649122782
-
-
US Department of Health and Human Services, Food and Drug Administration Accessed February 9, 2009
-
US Department of Health and Human Services, Food and Drug Administration. Common EMEA/FDA application for orphan medicinal product designation. http://www.fda.gov/oia/FDA-3671.pdf Accessed February 9, 2009
-
Common EMEA/FDA application for orphan medicinal product designation
-
-
|