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Regulatory Region - North America


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25 April 2012
Ian Haydock
Japan is beginning to intensify political debate on a formal system for the "compassionate use" of unapproved drugs, in a move that might bring it into line with similar schemes in the US and EU. The key word is "might", as it remains far from clear ...
 
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. ...
 
04 May 2012
Planned change on the choice of reference product for biosimilars in the EU means global development is on the agenda. Maureen Kenny reports from the ...
28 February 2012
Alex Cvetkovich Muntaņola and Kathryn Bohannon explain how drug developers can avoid some of the common mistakes companies make in the design and ...
28 February 2012
Phil Greenfield reports on evidence that suggests that more and more companies regard sub-Saharan Africa as a viable and stable long-term market. At ...
 
Regulatory Affairs Medtech News Roundup, December 2010
09 December 2010
 
Becker Consulting expands medtech team US-based life sciences consultancy agency, Becker & Associates Consulting, has added new members to its team of medical device experts 1 . Mary Getz has joined the firm's medical device practice as director of quality systems. Dr Getz has over 25 ...
Lilly's John Lechleiter appointed as PhRMA chairman US research-based pharmaceutical industry association PhRMA has elected Eli Lilly and Company's John C Lechleiter as its new chairman 1 . Dr Lechleiter, who has served as chairman, president and CEO of Lilly since 2008, succeeds Sanofi's CEO, ...
 
   
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