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23 July 2014

 
22 July 2014

Proving that there are other regulatory issues besides the proposed medical device and IVD regulations for EU decision makers to consider, the European Commission has issued a 10-week public consultation on the safe use of nanomaterials in medical ...

22 July 2014

The International Conference on Harmonisation has finalized guidance to help drug makers identify, categorize and control impurities in drugs that can damage DNA and limit the potential for these impurities to cause cancer 1 ,2 . The M7 guideline ...

22 July 2014

Over the next few months, a number of medtech notified bodies and manufacturers will try out the recent recommendations issued by the EU Notified Bodies Recommendation Group (NBRG) on addressing deviations between Annexes Z of EN ISO 14971:2012, the ...

21 July 2014

The US Food and Drug Administration has proposed updating its 16-year-old guidelines on the informed consent process for drug and medical device trials to respond to changes in related regulations and regulatory policy, and to address numerous ...

22 July 2014

Proving that there are other regulatory issues besides the proposed medical device and IVD regulations for EU decision makers to consider, the European Commission has issued a 10-week public consultation on the safe use of nanomaterials in medical ...

22 July 2014

The International Conference on Harmonisation has finalized guidance to help drug makers identify, categorize and control impurities in drugs that can damage DNA and limit the potential for these impurities to cause cancer 1 ,2 . The M7 guideline ...

22 July 2014

Over the next few months, a number of medtech notified bodies and manufacturers will try out the recent recommendations issued by the EU Notified Bodies Recommendation Group (NBRG) on addressing deviations between Annexes Z of EN ISO 14971:2012, the ...

21 July 2014

The unexpected exit of Altaf Ahmed Lal from his position as director of the US Food and Drug Administration's office in India has left many questions unanswered, though there is optimism in the pharma industry that the agency's recent efforts to ...

22 July 2014

Over the next few months, a number of medtech notified bodies and manufacturers will try out the recent recommendations issued by the EU Notified Bodies Recommendation Group (NBRG) on addressing deviations between Annexes Z of EN ISO 14971:2012, the ...

21 July 2014

The US Food and Drug Administration has proposed updating its 16-year-old guidelines on the informed consent process for drug and medical device trials to respond to changes in related regulations and regulatory policy, and to address numerous ...

18 July 2014

Japan's medicines regulator will in fiscal year 2016 start to accept electronically-submitted study data from drug makers seeking market approval, as part of the agency's plan to make electronic submission for study data mandatory. The Ministry of ...

18 July 2014

The EU is facing more delays over the listing of the international medical devices symbols standard, EN ISO 15223-1-2012. It appears that more modifications are needed, and that these still need to be examined by the relevant technical committee ...

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 ...

10 July 2014

The pharmaceutical industry has hit out once more against the growing trend by governments in the EU to promote as a means of saving money the off-label use of drugs in indications for which an approved medicine is already available. The reaction ...

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 ...

 
09 July 2014
Ashley Yeo
China's disease profile is changing and the country offers compelling prospects for manufacturers of innovative high-risk medical devices. In the period 2002-2013, the incidence of type II diabetes in the Chinese population, for example, rose from ...
 
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 ...
 
 
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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