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19 December 2014

In a decision that will be welcomed by the biotechnology industry, the Court of Justice of the EU has ruled that a parthenote - an unfertilized human ovum stimulated to grow by parthenogenesis - is not capable of developing into a human being and so ...

19 December 2014

The European Commission is planning to adopt an opinion in early 2015 which will dictate the future regulation in the EU of dermal fillers. The commission is preparing the opinion after the Dutch government said in July that it would ban permanent, ...

18 December 2014

The EU is still not ready to make use of the single audit program for medical devices developed by the International Medical Device Regulators Forum 1 . The Notified Bodies Operations Group (NBOG), which comprises representatives from EU member ...

18 December 2014

The European Commission has abandoned efforts to reach agreement on a revised version of the EU's price transparency directive, and has recommended that the draft legislation should no longer be pursued 1 ,2 . In an annex to its 2015 work program, ...

19 December 2014

In a decision that will be welcomed by the biotechnology industry, the Court of Justice of the EU has ruled that a parthenote - an unfertilized human ovum stimulated to grow by parthenogenesis - is not capable of developing into a human being and so ...

19 December 2014

The European Commission is planning to adopt an opinion in early 2015 which will dictate the future regulation in the EU of dermal fillers. The commission is preparing the opinion after the Dutch government said in July that it would ban permanent, ...

18 December 2014

The EU is still not ready to make use of the single audit program for medical devices developed by the International Medical Device Regulators Forum 1 . The Notified Bodies Operations Group (NBOG), which comprises representatives from EU member ...

18 December 2014

The European Commission has abandoned efforts to reach agreement on a revised version of the EU's price transparency directive, and has recommended that the draft legislation should no longer be pursued 1 ,2 . In an annex to its 2015 work program, ...

18 December 2014

The innovator and generics industries in Europe have teamed up to call for a more stable and predictable EU market environment that supports investment in innovative drugs while promoting "healthy and sustainable" competition in the form of generic ...

15 December 2014

The US Food and Drug Administration has signaled its willingness to facilitate efforts by generic drug sponsors to gain access to brand drugs with a risk evaluation and mitigation strategy (REMS) 1 . However, whether the agency's proposed policy ...

15 December 2014

The proportion of 510(k) medical device marketing applications in the US that the Food and Drug Administration refuses to accept for a full review upon first submission is declining 1 ,2 . This is a good sign for companies who had complained that ...

12 December 2014

The adoption of personalized medicines has failed to meet expectations, mainly because of disharmony among the regulations governing drugs and diagnostics, but also because of the challenges posed by rapid technological advances and differences in ...

11 December 2014

The European Generic medicines Association (EGA) has decided to join the European Stakeholders' Model (ESM), a product verification system set up by industry and distributor bodies to tackle the trade in falsified medicines, despite its initial ...

10 December 2014

The German regulatory agency BfARM has suspended 80 generic drugs whose marketing authorizations relied on bioequivalence (BE) tests conducted by the Indian CRO GVK Biosciences 1 . GVK Biosciences' procedures have been called into doubt following a ...

08 December 2014

Roche and Novartis say they will continue to fight against the fine imposed on them earlier this year for allegedly colluding to exclude Roche's Avastin from the ophthalmology market in favor of Novartis's much more expensive Lucentis, despite ...

02 December 2014

The US Food and Drug Administration has released a draft guidance that explains how drug manufacturers, repackagers, wholesale distributors and dispensers should exchange transaction information, histories and statements when engaging in agreements ...

19 December 2014

In a decision that will be welcomed by the biotechnology industry, the Court of Justice of the EU has ruled that a parthenote - an unfertilized human ovum stimulated to grow by parthenogenesis - is not capable of developing into a human being and so ...

16 December 2014

The US Patent & Trademark Office has revised the guidance it issued in March that was aimed at addressing two Supreme Court rulings that rocked the life sciences sectors but which patent lawyers and biopharmaceutical firms said had shortcomings 1 ,2 ...

11 December 2014

The companies involved in making the three lead Ebola vaccines have gained liability protection in the US by a declaration from the Obama administration acting under the Public Readiness and Emergency Preparedness (PREP) Act of 2005 1 . The vaccines ...

 
11 December 2014
Ashley Yeo
As medical device regulatory systems - and users' understanding of them - have matured, so has the relationship between the regulators and the regulated. The entrenched 'us and them' positioning that might once have held sway has over time given way ...
 
07 November 2014
Maureen Kenny
The appointment of Professor Sir Michael Rawlins as chair of the UK Medicines and Healthcare ...
 
18 December 2014
Yuri Afonchikov tells drug sponsors how to navigate Russia's clinical trial and regulatory approval ...
17 December 2014
Manuel Campolini and Ignace Vernimme discuss the regulatory developments relating to the Bolar ...
10 December 2014
Neil Coulson and Michael Short discuss the new intellectual property right trends for medical ...
 
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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
 
US FDA's drugs center gets permanent regulatory policy head The US Food and Drug Administration has promoted Grail Sipes to permanent director of its Office of Regulatory Policy at ...
Law enforcement expert named as new compliance chief at US FDA drug center The US Food and Drug Administration has hired Cynthia Schnedar as the new head of compliance at its Center for Drug ...
 
   
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