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17 September 2014

 
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 ...

17 September 2014

A proposal by the US Food and Drug Administration to amend and clarify its regulations governing classification and re-classification of medical devices could fundamentally change the classification process and result in more devices having to ...

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 ...

16 September 2014

The three-month consultation on new South African proposals to establish general regulations relating to medical devices and in vitro diagnostic medical devices closed in mid-July, with industry hopeful that impetus has been newly injected into the ...

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 ...

17 September 2014

A proposal by the US Food and Drug Administration to amend and clarify its regulations governing classification and re-classification of medical devices could fundamentally change the classification process and result in more devices having to ...

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 ...

16 September 2014

The three-month consultation on new South African proposals to establish general regulations relating to medical devices and in vitro diagnostic medical devices closed in mid-July, with industry hopeful that impetus has been newly injected into the ...

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 ...

17 September 2014

A proposal by the US Food and Drug Administration to amend and clarify its regulations governing classification and re-classification of medical devices could fundamentally change the classification process and result in more devices having to ...

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 ...

15 September 2014

The US Food and Drug Administration is to look into developing an international genomically-driven trial as part of efforts to accelerate the development of targeted drugs for patients with metastatic breast cancer 1 . The genomically-driven trial ...

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 ...

12 September 2014

The ten nations that constitute the Association of South East Asian Nations have formally signed an agreement to implement the ASEAN Medical Device Directive (AMDD) in their respective jurisdictions by the end of 2015. However, it is unclear whether ...

08 September 2014

EU regulatory agencies and the pharmaceutical industry have teamed up in an effort to harness the power of social media, launching a new project in response to the growing use of smartphones, apps and social media by patients and healthcare ...

05 September 2014

The European Medicines Agency has issued updated guidance to help drug companies submit periodic safety update reports (PSURs) for nationally authorized medicines that are subject to a single EU assessment 1 ,2 . The EMA explains that marketing ...

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 ...
 
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
 
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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