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21 September 2014

 
19 September 2014

The US Food and Drug Administration is inviting feedback on its plans to undertake a study to explore the feasibility of standardizing medical device labeling across the country 1 . As part of the study, the FDA wants to compare existing labeling ...

19 September 2014

The US government on 18 September said it was serious about combating antimicrobial resistance (AMR) and issued three documents laying out a multi-strategy plan of attack, which officials said demonstrated President Barack Obama commitment of making ...

19 September 2014

The European Medicines Agency has issued new requirements on how drug companies should manage and report adverse reactions from non-interventional post-authorization safety studies. The requirements, which are outlined in a revised EMA guideline on ...

18 September 2014

The European Medicines Agency has dismissed suggestions that the appointment in 2013 of a new head of legal services with a pharmaceutical industry background had a significant influence on the development of its draft policy on clinical trial data ...

19 September 2014

The US Food and Drug Administration is inviting feedback on its plans to undertake a study to explore the feasibility of standardizing medical device labeling across the country 1 . As part of the study, the FDA wants to compare existing labeling ...

19 September 2014

The US government on 18 September said it was serious about combating antimicrobial resistance (AMR) and issued three documents laying out a multi-strategy plan of attack, which officials said demonstrated President Barack Obama commitment of making ...

19 September 2014

The European Medicines Agency has issued new requirements on how drug companies should manage and report adverse reactions from non-interventional post-authorization safety studies. The requirements, which are outlined in a revised EMA guideline on ...

18 September 2014

The European Medicines Agency has dismissed suggestions that the appointment in 2013 of a new head of legal services with a pharmaceutical industry background had a significant influence on the development of its draft policy on clinical trial data ...

19 September 2014

The US Food and Drug Administration is inviting feedback on its plans to undertake a study to explore the feasibility of standardizing medical device labeling across the country 1 . As part of the study, the FDA wants to compare existing labeling ...

19 September 2014

The US government on 18 September said it was serious about combating antimicrobial resistance (AMR) and issued three documents laying out a multi-strategy plan of attack, which officials said demonstrated President Barack Obama commitment of making ...

18 September 2014

The European Medicines Agency has dismissed suggestions that the appointment in 2013 of a new head of legal services with a pharmaceutical industry background had a significant influence on the development of its draft policy on clinical trial data ...

17 September 2014

A common market in medical device registration for the member countries of the new Eurasian Economic Union is being discussed in a consultation posted by the Russian Federation on 3 September 1 . The consultation (G/TBT/N/RUS/38), which was issued ...

19 September 2014

The European Medicines Agency has issued new requirements on how drug companies should manage and report adverse reactions from non-interventional post-authorization safety studies. The requirements, which are outlined in a revised EMA guideline on ...

18 September 2014

The UK Medicines and Healthcare Products Regulatory Agency is inviting feedback from medical device manufacturers on its plans to introduce a fee for processing each certificate of free sale (CFS) application as of April 2015 1 . CFSs are currently ...

18 September 2014

The US Food and Drug Administration has been accused of engaging in the practice of medicine and of promoting the very products it regulates after it posted an article in which regulators advised "Don't leave childhood depression untreated," and ...

17 September 2014

With more emerging economies starting to look to biosimilars as a potential source of cost savings on expensive biological medicines, discussions are intensifying over issues such as the regulatory systems used to approve biosimilars, how best to ...

19 August 2014

The top court of the US state of Alabama has reaffirmed its decision last year that brand-name drug makers like Pfizer can be held liable for a lack of warnings on generic forms of their medicines. The ruling could have implications in other ...

15 August 2014

Europe's pharmaceutical industry body EFPIA has again set out its views on just how much clinical trial data should be shared with researchers and the public, this time in a blog entitled 'A 3D view of responsible clinical data sharing' that insists ...

14 August 2014

The US Food and Drug Administration is inviting feedback on its proposal for the data that makers of biological products would have to submit to the agency to qualify for a 12-year "reference product exclusivity" during which approval of a ...

 
15 September 2014
Ashley Yeo
A blissful summer - albeit now swiftly receding - free of political sparring over the European Commission's proposed twin medtech regulations? Or did you miss the duck and weave, the EU medtech industry being pummelled but still standing and coming ...
 
11 February 2014
Maureen Kenny
?If you don?t finance it correctly, it will implode.? This was the stark warning key European drug ...
 
09 September 2014
As the September 24 deadline approaches for Class III medical device manufacturers to comply with ...
29 August 2014
The UK Intellectual Property Office has rejected two applications for supplementary protection ...
21 August 2014
Fabienne Diekmann explains how things are changing for medtech under the new medical product ...
 
 
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
 
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 ...
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 ...
 
   
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