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RECENT TWEETS    
29 July 2014

 
28 July 2014

The European Medicines Agency is inviting feedback on how its pharmacovigilance committee, the PRAC, should organize and conduct the public hearings that the committee is planning to hold as part of certain safety reviews of medicines 1,2 . The ...

25 July 2014

South Korea has proposed several changes to its current good manufacturing practice requirements for medical devices, including allowing third party institutions to inspect Class II products so that government authorities may focus their inspection ...

25 July 2014

Some company had to be the first to file a biosimilar application with the US Food and Drug Administration under the approval pathway created by Congress in 2010 as part of the Affordable Care Act. It seems Sandoz may be that firm. On 24 July, the ...

24 July 2014

The European Commission has updated its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices to include a section on software and mobile applications 1 . This latest version of the manual also provides ...

28 July 2014

The European Medicines Agency is inviting feedback on how its pharmacovigilance committee, the PRAC, should organize and conduct the public hearings that the committee is planning to hold as part of certain safety reviews of medicines 1,2 . The ...

25 July 2014

South Korea has proposed several changes to its current good manufacturing practice requirements for medical devices, including allowing third party institutions to inspect Class II products so that government authorities may focus their inspection ...

25 July 2014

Some company had to be the first to file a biosimilar application with the US Food and Drug Administration under the approval pathway created by Congress in 2010 as part of the Affordable Care Act. It seems Sandoz may be that firm. On 24 July, the ...

24 July 2014

The European Commission has updated its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices to include a section on software and mobile applications 1 . This latest version of the manual also provides ...

25 July 2014

South Korea has proposed several changes to its current good manufacturing practice requirements for medical devices, including allowing third party institutions to inspect Class II products so that government authorities may focus their inspection ...

25 July 2014

Some company had to be the first to file a biosimilar application with the US Food and Drug Administration under the approval pathway created by Congress in 2010 as part of the Affordable Care Act. It seems Sandoz may be that firm. On 24 July, the ...

24 July 2014

The European Commission has updated its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices to include a section on software and mobile applications 1 . This latest version of the manual also provides ...

24 July 2014

As the technology behind personalized medicine continues to accelerate - with diagnostics increasingly being used to make treatment decisions - the US Food and Drug Administration should consider introducing a procedure whereby manufacturers can ...

28 July 2014

The European Medicines Agency is inviting feedback on how its pharmacovigilance committee, the PRAC, should organize and conduct the public hearings that the committee is planning to hold as part of certain safety reviews of medicines 1,2 . The ...

15 July 2014

It is still too early to tell what will be the precise spin-offs for pharmaceutical and medical device companies under the new Eurasian Economic Treaty, which brings enhanced levels of trade integration between Russia, Belarus and Kazakhstan. ...

15 July 2014

The EU Notified Bodies Recommendation Group has issued a draft consensus paper explaining how medical device manufacturers should interpret and apply Annexes Z of EN ISO 14971:2012, the key medical device standard on risk management, to show ...

11 July 2014

European medical device association Eucomed is working with its diagnostics counterpart, EDMA, to develop a common code of ethical business practices with healthcare professionals. Two top-level executives for both groups, Serge Bernasconi and Aline ...

11 July 2014

The European Commission has imposed fines totaling Euros 427.7 million on Servier and five producers of generic medicines for anti-competitive practices ? a decision that the French drug maker says sets a "regrettable precedent" for industries that ...

02 July 2014

Indian firms have launched a strong counter attack against Big Pharma's attempts to deride the country's intellectual property rights (IPR) regime and also thrown in an indirect challenge that they claim will call the US's 'bluff' on India's patent ...

30 June 2014

Rejections by the US Patent and Trademark Office of patent applications for biotechnology-related inventions appear to significantly be on the rise. This is the finding of an assessment that lawyers at Robins, Kaplan, Miller & Ciresi (RKMC) carried ...

 
24 July 2014
Ian Schofield
Countries around the world are joining forces to tackle some of the strategies used by multinational pharmaceutical companies to secure their market share, keep up drug prices and maximize their revenues. At least that's the way it seems, as the ...
 
11 February 2014
Maureen Kenny
?If you don?t finance it correctly, it will implode.? This was the stark warning key European drug ...
 
10 July 2014
Paul Ranson and Helen Cline examine how the new EU adaptive licensing proposals could be ...
08 July 2014
Katherine Wang discusses moves by China's regulators to incentivize pediatric drug ...
07 July 2014
Maria Isabel Manley and Marina Vickers argue that the policy-driven approach by European regulators ...
 
MOST READ
 
12 November 2013
Joint assessments by national designating authorities in the EU of notified bodies active in the medical device area are relatively new. A voluntary ...
28 August 2013
Ken Daly looks to the US to predict what could happen in Europe if the European Commission's recommendation for an EU-wide class action system is ...
05 July 2013
The French medtech market is already highly regulated and complex and is becoming more so. While the CE marking should act as a single passport to ...
 
A candid look at the European drug regulatory network from Jytte Lyngvig, CEO of the Danish Medicines Agency 2000-2012
18 January 2013
 
Onwards and upwards for Steven Galson at Amgen Steven Galson has had his responsibilities at Amgen expanded. The former director of the US Food and Drug Administration's ...
Howard Sklamberg, drugs compliance director at US FDA, takes on global role at agency Howard Sklamberg, the director of the Office of Compliance at the US Food and Drug Administration?s drugs center CDER, is ...
 
   
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