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Regulatory Region - North America
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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 the times. The Danish government, which took over the presidency from Poland on 1 January, has set ...
INTERVIEW
The views of US FDA chief Margaret Hamburg
08 November 2010
Daniel B Moskowitz
The FDA commissioner tells Dan Moskowitz about balancing benefit and risk, improving transparency and efficiency and the challenges of globalisation. ...
LATEST FEATURES
Lessons to be learned courtesy of PIP
23 January 2012
Jeremy Tinkler considers who and what is to blame in the sub-standard breast implants affair and what can be done to close any regulatory ...
Getting closer to regulatory harmony in a shrinking pharma world
12 January 2012
Gill King and Joel Finkle explore some of the key developments relating among other things to document submission that have taken place over the past ...
Lessons to learn from the US as EU device regulators move ahead with reuse legislation
11 January 2012
As the European Commission considers whether to regulate the reuse of single-use devices, Peter Schröer talks to Ashley Yeo about the controversial ...
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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
Regulatory Affairs Medtech News Roundup, December 2010
09 December 2010
PEOPLE
US generic industry association gets new regulatory science vice-president
US generic pharmaceutical industry association GPhA has appointed David Gaugh as its vice-president for regulatory sciences 1 . Mr Gaugh has more than 25 years of leadership experience within the healthcare and generic pharmaceutical industries, ...
Senior official from US FDA's device unit joins Becker Consulting
Tim Ulatowski, former director of the US Food and Drug Administration 's Office of Compliance at the agency's medical device unit, has joined Becker & Associates Consulting 1 . Mr Ulatowski has become director, medical devices, of Becker ...
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