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27 January 2015

 
27 January 2015

A new European Commission expert group is scheduled to discuss today the flaws in the EU conditional marketing authorization pathway. The pathway is one of several tools aimed at bringing important new medicines to market faster, but it has been ...

27 January 2015

Cardiologist Robert Califf, vice chancellor of clinical and translational research at Duke University , has been appointed the US Food and Drug Administration' s new deputy commissioner for medical products and tobacco - a move that has some ...

27 January 2015

The European Medicines Agency is starting a new service under which the labeling recommendations issued by the agency's pharmacovigilance risk assessment committee, PRAC, will be translated into all official EU languages. The service, which should ...

27 January 2015

The EU notified bodies association, TEAM-NB, will hold face-to-face meetings in April with its members following a potentially highly damaging media report in which a notified body is alleged to have said it could foresee no problem with mesh ...

27 January 2015

A new European Commission expert group is scheduled to discuss today the flaws in the EU conditional marketing authorization pathway. The pathway is one of several tools aimed at bringing important new medicines to market faster, but it has been ...

27 January 2015

Cardiologist Robert Califf, vice chancellor of clinical and translational research at Duke University , has been appointed the US Food and Drug Administration' s new deputy commissioner for medical products and tobacco - a move that has some ...

27 January 2015

The European Medicines Agency is starting a new service under which the labeling recommendations issued by the agency's pharmacovigilance risk assessment committee, PRAC, will be translated into all official EU languages. The service, which should ...

27 January 2015

The EU notified bodies association, TEAM-NB, will hold face-to-face meetings in April with its members following a potentially highly damaging media report in which a notified body is alleged to have said it could foresee no problem with mesh ...

27 January 2015

A new European Commission expert group is scheduled to discuss today the flaws in the EU conditional marketing authorization pathway. The pathway is one of several tools aimed at bringing important new medicines to market faster, but it has been ...

27 January 2015

The European Medicines Agency is starting a new service under which the labeling recommendations issued by the agency's pharmacovigilance risk assessment committee, PRAC, will be translated into all official EU languages. The service, which should ...

27 January 2015

The EU notified bodies association, TEAM-NB, will hold face-to-face meetings in April with its members following a potentially highly damaging media report in which a notified body is alleged to have said it could foresee no problem with mesh ...

26 January 2015

Device companies interested in the US Food and Drug Administration's new voluntary program for faster evaluation of certain high-risk devices for unmet medical needs can hope to get a clearer picture of the initiative when the agency issues final ...

26 January 2015

The European Medicines Agency is preparing to launch a new service under which it would monitor medical literature for reports of suspected adverse reactions from drugs containing certain active substances, and then submit the relevant case reports ...

26 January 2015

A new joint working group comprising members of the European Medicines Agency's pharmacovigilance (PRAC) and pediatric committees (PDCO) has been created to exchange information and expertise on pediatric safety issues at both committees and to ...

23 January 2015

Pharmaceutical companies with nationally authorized products on the EU market will find out soon what the European Medicines Agency thinks their annual pharmacovigilance fee should be 1 . In April, the EMA will start sending such companies advisory ...

22 January 2015

Europe is set to modernize how it conducts some aspects of pharmacovigilance with the launch of a web app in March this year for patients to report adverse drug reactions (ADRs) and a drive to monitor web chatter on the issue. Mick Foy, Group ...

26 January 2015

The judgement by a High Court judge that the launch by Actavis of a generic version of Pfizer's Lyrica (pregabalin) in the UK would not infringe a patent held by Pfizer company Warner-Lambert on one of the three uses for which Lyrica is approved 1,2 ...

19 January 2015

Companies are finally set to get legal clarity on one of the biggest causes of contention between the pharma industry and Brazilian authorities. The courts will eventually decide on the legality of the medicine regulator's role in vetoing patent ...

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 ...

 
20 January 2015
Ashley Yeo
It?s decision year for the proposed EU Medical Device Regulation , and by the end of 2015 its final shape should be known. That is if the current Council of the EU deadlines (below) under the Latvian presidency and the subsequent talks with the ...
 
07 November 2014
Maureen Kenny
The appointment of Professor Sir Michael Rawlins as chair of the UK Medicines and Healthcare ...
 
27 January 2015
The European Commission says that pharmaceutical companies whose products are not covered by the ...
15 January 2015
As drug regulation becomes more global in nature, international trade continues to expand, and drug ...
09 January 2015
The global regulatory environment for controlled substances is bound to get more complex before it ...
 
 
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: Generic drugs top lobbyist to depart by fall Ralph Neas, the president and CEO of the Generic Pharmaceutical Association , has said he plans to leave the lobbying group ...
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 ...
 
   
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