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14 April 2011

This is fantastic, now we can have both text and image content on the top of the page and not as Breaking news but as a Highlight!

 
08 September 2011

A Supreme Court judge set to hear a case involving a challenge by Novartis against Section 3d, a controversial provision in India's patent law, has recused himself ? a move that is now expected to require a new judge to hear the case at a later date ...

08 September 2011

A new guidance on developing human cells for clinical applications is available 1 . The guidance was issued by the British Standards Institution , which says the document was written with an EU/US audience in mind and anticipates that it will be ...

08 September 2011

The US Food and Drug Administration has expressed concern over the protracted negotiations it is having with the medtech industry over reauthorising its medical device user fee programme, minutes from a 2 August meeting between the FDA and industry ...

08 September 2011

The US Food and Drug Administration is introducing two new training programmes to improve the consistency and skill of its medical device unit staff who review pre-market applications 1 . The programmes, designed for reviewers at the FDA?s Center ...

08 September 2011

A Supreme Court judge set to hear a case involving a challenge by Novartis against Section 3d, a controversial provision in India's patent law, has recused himself ? a move that is now expected to require a new judge to hear the case at a later date ...

08 September 2011

A new guidance on developing human cells for clinical applications is available 1 . The guidance was issued by the British Standards Institution , which says the document was written with an EU/US audience in mind and anticipates that it will be ...

04 August 2011

08 September 2011

A new guidance on developing human cells for clinical applications is available 1 . The guidance was issued by the British Standards Institution , which says the document was written with an EU/US audience in mind and anticipates that it will be ...

08 September 2011

The US Food and Drug Administration has expressed concern over the protracted negotiations it is having with the medtech industry over reauthorising its medical device user fee programme, minutes from a 2 August meeting between the FDA and industry ...

08 September 2011

The US Food and Drug Administration is introducing two new training programmes to improve the consistency and skill of its medical device unit staff who review pre-market applications 1 . The programmes, designed for reviewers at the FDA?s Center ...

02 August 2011

The Danish Medicines Agency has issued a list clarifying which clinical trial amendments will require approval by the DMA and which modifications can merely be notified to the agency 1 ,2 . The list has been issued in response to questions on the ...

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 Senate Judiciary Committee has approved a bipartisan bill to limit pay-for-delay settlements that the bill's supporters say will keep lower-cost generic drugs off the market 1 ,2 .  The Preserve Access to Affordable Generic Drugs Act, which ...

22 July 2011

Ravimiamet, Estonia's drug regulatory agency, has intensified its oversight of television advertisements for medicinal products, after finding that all advertisements televised on three TV channels in June failed to comply fully with the legal ...

22 July 2011

Australia's Therapeutic Goods Administration's "should move away from the conservative approach that has characterised its actions in the past and recognise that it has a duty to collaborate with stakeholders to create a culture in which the ...

08 September 2011

A Supreme Court judge set to hear a case involving a challenge by Novartis against Section 3d, a controversial provision in India's patent law, has recused himself ? a move that is now expected to require a new judge to hear the case at a later date ...

26 July 2011

The US Senate Judiciary Committee has approved a bipartisan bill to limit pay-for-delay settlements that the bill's supporters say will keep lower-cost generic drugs off the market 1 ,2 .  The Preserve Access to Affordable Generic Drugs Act, which ...

18 July 2011

The governments of New Zealand and Australia have agreed on a new trans-Tasman plan to implement a single patent application and examination process for both countries that would provide inventors with a faster, cheaper and more streamlined patent ...

 
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 . ...
 
28 January 2011
Maureen Kenny
Drug companies have in the past been reluctant to protest too much when major regulatory agencies ? ...
 
28 July 2011
Michael Pears and Mike Snodin consider the opinion of an Advocate General of the Court of Justice ...
26 July 2011
Joan Mendivil outlines the complex relationship between central government and the devolved regions ...
21 June 2011
Ellen Leinfuss discusses six key triggers that may attract an inspector's aggressive scrutiny of ...
 
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21 July 2011
Nanoparticle iron (NPI) products are used as diagnostic MRI contrast agents and as therapies for iron-deficiency anaemia. David Snodin argues that a ...
21 July 2011
Nanoparticle iron (NPI) products are used as diagnostic MRI contrast agents and as therapies for iron-deficiency anaemia. David Snodin argues that a ...
19 July 2011
It will be good news for the innovative pharmaceutical industry if the Court of Justice of the EU accepts the opinion of one of its advocates general ...
 
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
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
 
RAJ Devices News Roundup, 11 December 2009
28 July 2011
 
New partner and name change for German law firm German law firm Lützeler Klümper Wachenhausen Rechtsanwälte has a new partner and a new name. Heike Wachenhausen, who joined the firm recently, ...
Egypt's health ministry appoints new pharmacy and pharmaceutical products sector assistant Professor Aiman El-Khatib has been appointed minister of health assistant for the pharmacy and pharmaceutical products sector of the Egyptian ...
 
   
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