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Regulatory Region - North America
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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 . ...
INTERVIEW
The US FDA?s Medical Device Postmarket Transformation Initiative
20 May 2009
Carolyn Waterworth
US manufacturers of medical devices can expect to see increased scrutiny of their postmarketing reports as the US Food and Drug Administration ?s ...
LATEST FEATURES
US FDA inspections, current good manufacturing practices and the new "healthcare fraud"
21 June 2011
Ellen Leinfuss discusses six key triggers that may attract an inspector's aggressive scrutiny of cGMP compliance and product quality. The US ...
test-Understanding the US Programme for Bioresearch Monitoring
16 November 2010
Following the pledge by the Food and Drug Administration to step up efforts regarding its programme for ensuring the validity of the scientific data ...
Shared responsibility in medical device safety and performance
10 September 2010
As the World Health Organization prepares for its first global medical devices forum, Michael Cheng calls on the WHO to bridge the gap ? the role of ...
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LATEST COUNTRY PROFILES
Trademarks Briefing (Pharma) - 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 ...
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 ...
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MULTIMEDIA
RAJ Devices News Roundup, 11 December 2009
28 July 2011
PEOPLE
ACRP appoints chair of GCC
The US-based Association of Clinical Research Professionals has confirmed the appointment of Dr Satish Chandra as chairman of the association's Gulf Cooperative Council (GCC) Chapter. Dr Chandra is a specialist and head of clinical research at Tawam ...
Critical Path Institute seeks new leader as founder retires
The founder of the Arizona-based Critical Path Institute (C-Path), Raymond Woosley , has announced that he is to retire on 31January 2012, leaving its board of directors in search of a new chief executive 1 . Woosley founded C-Path six years ago as ...
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