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Home - Editorials
EDITORIALS
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EXPERT VIEW
Assessing the size of the US recall issue
27 April 2011
Ashley Yeo
With the US in mid-regulatory review, stakeholders are keenly pushing for a safer and faster system, but there are different views on how these goals should be achieved. That was shown at a hearing of the US Senate's Special Committee on Aging 1 . ...
ANALYSIS
EMA reflection paper on generic nanoparticle iron products: a case of bias by omission?
21 July 2011
Nanoparticle iron (NPI) products are used as diagnostic MRI contrast agents and as therapies for iron-deficiency anaemia. David Snodin argues that a European Medicines Agency working party should reconsider its position in its reflection paper that ...
Advancing regenerative medicine in the US requires regulatory change
27 April 2011
Americans have been engaged in a detailed and politically charged debate about healthcare reform for the past few years, but there has been surprisingly little discussion about ways new technologies such as regenerative medicine can improve clinical ...
Perfect companions: using genetic tests to tailor drug treatment to the patient
23 February 2011
A recent PricewaterhouseCoopers report estimated that the core diagnostic and therapeutic segment of the US personalised medicine market is worth $24bn. This figure is expected to nearly double by 2015, reaching $42bn. Peter Charlish investigates ...
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FEATURES
EMA seeks out ATMP manufacturers in advance of approval deadlines
18 February 2011
Maureen Kenny reports on efforts by the European Medicines Agency to ensure manufacturers of advanced therapies won't be caught out by approaching ...
The revision of the EU medical device directives revision and variations in national laws
12 January 2011
How successful have the EU member states been in implementing the revision of the medical device directives into national law? And has this been done ...
ISO 14644: cleanroom classification and monitoring changes ahead
10 January 2011
Tony Harrison explains why the key revisions in the draft of international standard ISO 14644 will affect GMP-compliant companies. Parts 1 and 2 of ...
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LATEST COUNTRY PROFILES
Trademarks Briefing (Devices) - Luxembourg
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
Regulation of Medical Devices Briefing - Spain
08 October 2009
1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain? Agencia Española del Medicamento, the ...
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MULTIMEDIA
RAJ Devices News Roundup, 11 December 2009
28 July 2011
PEOPLE
AdvaMedDx names associate vice president
Policy analyst Tharini Sathiamoorthy has been named associate vice president of AdvaMedDx, the diagnostics arm of US medtech industry association AdvaMed . Ms Sathiamoorthy was previously a senior associate in the health policy practice at public ...
Michael Carome joins Public Citizen's Health Research Group
Michael Carome, an internationally recognised expert on the protection of human research subjects, has been appointed deputy director of the Health Research Group of the US consumer advocacy organisation Public Citizen . Prior to joining HRG, Dr ...
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EVENTS
Overview of ISO 13485:2003, the CMDRs, the MDD, and JPAL
21September 2009
Minneapolis (MN), US
