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Regulatory Region - North America
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EXPERT VIEW
Japan compassionate use drugs proposal faces regulatory minefield
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 ...
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
"A huge step" towards global biosimilars development
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 ...
Early phase paediatric drug trials - avoiding the pitfalls
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 ...
Challenges and opportunities for medical devices and diagnostics in Africa
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 ...
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MULTIMEDIA
Regulatory Affairs Medtech News Roundup, December 2010
09 December 2010
PEOPLE
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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