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26 July 2011

The US Food and Drug Administration is to hold a workshop in which it will seek stakeholder feedback on the adoption, implementation and use of unique device identifiers in various health-related electronic data systems 1 . Implementing UDIs in ...

26 July 2011

The US Food and Drug Administration is to hold a workshop in which it will seek stakeholder feedback on the adoption, implementation and use of unique device identifiers in various health-related electronic data systems 1 . Implementing UDIs in ...

23 June 2011

The US Food and Drug Administration's procedures for overseeing medical device recalls are unclear and represent a missed opportunity for the agency to proactively identify and address risks presented by unsafe devices, the Government Accountability ...

10 January 2011

US medtech industry association AdvaMed has developed best practice guidance to help member companies comply with its revised code of conduct on ethical interactions with healthcare professionals that has been in place since July 2009 1-4 . The ...

04 November 2009

Orthopaedic specialist Stryker has said it is “disappointed” by a US federal grand jury indictment that accuses the company’s biotech division and several employees of improper marketing practices and intentionally defrauding the Food and Drug ...

19 July 2011

A broad coalition of US medical technology companies and industry associations is urging Congress to repeal the $20 billion medical device tax that is set to come into effect in 2013 1 . The 2.3% medical device tax, which was passed as a part of the ...

31 January 2011

The US Medical Imaging & Technology Alliance ( MITA ) is expecting to significantly strengthen its membership in the coming months by extending it to include the radiopharmaceutical industry 1 . MITA will seek to represent the radiopharma sector's ...

 
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 . ...
 
 
13 October 2009
Retta M Riordan examines manufacturers’ settlements with the government and provides advice on how to avoid prosecution. “Pfizer to pay record $2.3 ...
15 September 2009
The UK government in 2004 asked Philip Hampton, a leading businessman, to lead a review of regulatory inspection and enforcement across a number of ...
16 July 2009
The Global Harmonization Task Force has issued a key document that explains the overall design of the global regulatory model for medical devices ...
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
08 October 2009
1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain? Agencia Española del Medicamento, the ...
RAJ Devices News Roundup, 11 December 2009
28 July 2011
 
 
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