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Medicines A-Z
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8754 library items
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1.
Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications, 2006-2010
Source:
Value in Health
,
Date published:
21/05/2012
Category:
Food &Drug Administration (FDA)
NeLM
Area:
Evidence
>
Medicines Management
>
References
Abstract link (ScienceDirect)
2.
A review of patient-reported outcome labels in the United States: 2006 to 2010
Source:
Value in Health
,
Date published:
21/05/2012
Category:
Food &Drug Administration (FDA)
NeLM
Area:
Evidence
>
Medicines Management
>
References
Abstract link (ScienceDirect)
3.
A cohort study exploring determinants of safety-related regulatory actions for biopharmaceuticals
Source:
Drug Safety
,
Date published:
18/05/2012
Category:
Adverse Drug Reactions
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Government / regulatory
NeLM
Area:
Evidence
>
Medicines Management
>
References
Abstract link
4.
FDA statement on risk of cardiovascular death linked to azithromycin
Source:
FDA
,
Date published:
18/05/2012
Category:
5.1.5 Macrolides
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Adverse Drug Reactions
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Arrhythmias
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Food &Drug Administration (FDA)
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Information provision
NeLM
Area:
News
Press release
Link to NeLM report of study
5.
Horizon scanning: Positive one year data from GLOW2 study for Seebri® Breezhaler® (glycopyrronium bromide/NVA237) in COPD patients
Source:
PharmaLive
,
Date published:
18/05/2012
Category:
3.1.2 Antimuscarinic bronchodilators
|
Chronic Obstructive Airways Disease
|
European Agency for the Evaluation of Medicinal Products (EMEA)
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New drugs
NeLM
Area:
News
Link
6.
Medical Device Alert: Clever Chek blood glucose monitoring system distributed by BBI Healthcare
Source:
MHRA
,
Date published:
18/05/2012
Category:
Diabetes
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Drug Alerts
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Medicines and Healthcare products Regulatory Agency (MHRA)
NeLM
Area:
News
Link
7.
Heatwave Plan for England 2012 published
Source:
Department of Health (DH)
,
Date published:
18/05/2012
Category:
Department of Health (DH)
|
Public Health
NeLM
Area:
News
Link
8.
A 21 CFR Part 11 compliant graphically based electronic system for clinical research documentation
Source:
Journal of Medical Systems
,
Date published:
18/05/2012
Category:
Food &Drug Administration (FDA)
|
IT
NeLM
Area:
Evidence
>
Medicines Management
>
References
Abstract link
9.
NICE request your views on the provision of news about medicines
Source:
NICE
,
Date published:
17/05/2012
Category:
Information provision
|
IT
|
National Institute of Clinical Excellence (NICE)
NeLM
Area:
News
Link to registration page
10.
Regulatory review of novel therapeutics - comparison of three regulatory agencies
Source:
NEJM
,
Date published:
17/05/2012
Category:
European Agency for the Evaluation of Medicinal Products (EMEA)
|
Food &Drug Administration (FDA)
|
New drugs
NeLM
Area:
News
Abstract (subscription may be required for full text access)
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