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02 August 2014

 
01 August 2014

The US Food and Drug Administration has issued its much-awaited proposal on regulating laboratory-developed tests (LDTs), subjecting them - for the first time - to the agency's pre- and post-market requirements 1,2 . The FDA hopes that the new ...

31 July 2014

Nearly two months has passed since the new Italian requirements for registering IVDs in the national Repertorio database of medical devices (RDM) came into effect in June 1 but there is still much confusion among manufacturers. In particular, there ...

31 July 2014

The need for new regulatory and development pathways for antibiotics and the development of better rapid diagnostics dominated the first day of the 30-31 July US forum on the challenges related to antibacterial product development. "New antibiotics ...

31 July 2014

Professor Karl Broich is to take over as chair of the German medicines and medical devices regulator BfArM effective 6 August 1 . Professor Broich, who is currently vice-chair of the agency, succeeds Professor Walter Schwerdtfeger, who is retiring ...

01 August 2014

The US Food and Drug Administration has issued its much-awaited proposal on regulating laboratory-developed tests (LDTs), subjecting them - for the first time - to the agency's pre- and post-market requirements 1,2 . The FDA hopes that the new ...

31 July 2014

Nearly two months has passed since the new Italian requirements for registering IVDs in the national Repertorio database of medical devices (RDM) came into effect in June 1 but there is still much confusion among manufacturers. In particular, there ...

31 July 2014

The need for new regulatory and development pathways for antibiotics and the development of better rapid diagnostics dominated the first day of the 30-31 July US forum on the challenges related to antibacterial product development. "New antibiotics ...

31 July 2014

Professor Karl Broich is to take over as chair of the German medicines and medical devices regulator BfArM effective 6 August 1 . Professor Broich, who is currently vice-chair of the agency, succeeds Professor Walter Schwerdtfeger, who is retiring ...

01 August 2014

The US Food and Drug Administration has issued its much-awaited proposal on regulating laboratory-developed tests (LDTs), subjecting them - for the first time - to the agency's pre- and post-market requirements 1,2 . The FDA hopes that the new ...

31 July 2014

Nearly two months has passed since the new Italian requirements for registering IVDs in the national Repertorio database of medical devices (RDM) came into effect in June 1 but there is still much confusion among manufacturers. In particular, there ...

31 July 2014

The need for new regulatory and development pathways for antibiotics and the development of better rapid diagnostics dominated the first day of the 30-31 July US forum on the challenges related to antibacterial product development. "New antibiotics ...

30 July 2014

EU medical device notified bodies can anticipate in October this year an amended code of conduct carrying significant changes. The amendments will follow on from the most recent update to the code, which was published in July 1 and entails small ...

29 July 2014

Roche says it is considering whether to appeal against a recent UK judgment that dismissed its complaints over the way the Medicines and Healthcare Products Regulatory Agency (MHRA) handled information about the drug company's alleged failure to ...

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

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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