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EXPERT VIEW
Danes urge austerity as EU health issues loom large
11 January 2012
Ian Schofield
Much has been made of Denmark's announcement that its presidency of the EU Council of Ministers will be an austere one financially, in the spirit of ...
INTERVIEW
Industry stripped of seats on French drug regulatory bodies
06 February 2012
Ian Schofield
France's drug regulatory agency, Afssaps , has published details of the new membership of its various bodies and committees, including those ...
Distracting factors in drug ads on TV: US FDA seeks feedback on study results
06 February 2012
Vibha Sharma
The US Food and Drug Administration has released the results of a study that was conducted in support of the agency's plans to establish standards ...
First detailed EU guidance for device companies on authorised representative's role
06 February 2012
Amanda Maxwell
A new guideline from the European Commission represents the first single, collated document to shed light on the role of the medical device ...
Immediate improvements sought in EU-wide surveillance of medical devices
03 February 2012
Vibha Sharma, Bernard Murphy
The European Commission is looking at "immediate measures" to improve the surveillance of medical devices within the existing legal framework in ...
EMA lays out drug safety priorities for 2012
03 February 2012
Ian Schofield
Priorities for the European Medicines Agency in the drug safety area this year include a new urgent referral procedure, guidance on ...
Medtech industry gives nod to doubling of US FDA user fees in exchange for improved approval process - update
02 February 2012
Tina Tan, Vibha Sharma
The US Food and Drug Administration has "in principle" reached an agreement with the medtech industry to establish a faster, more predictable and ...
LATEST FEATURES
European court ruling on SPCs brings relief to pharma industry
03 January 2012
The acceptance by the European court of justice of supplementary protection certificates having non-positive terms is welcome news for the innovative ...
Industrial application test under the spotlight
28 December 2011
The UK Supreme Court 's decision in Human Genome Sciences v Lilly will be warmly welcomed by the biosciences sector, says Rob Jacob. It is a ...
Every day counts: why pharmaceutical companies in the EU need to make sure they get the right SPC term
23 September 2011
Pharmaceutical companies using the centralised authorisation procedure in the EU may be entitled to a slightly a longer supplementary certificate ...
>> More Latest Features...
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 Espaņola del Medicamento, the ...
>> More Latest Country Profiles...
MULTIMEDIA
Regulatory Affairs Medtech News Roundup, December 2010
09 December 2010
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