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02 September 2015

 
01 September 2015

The European pharmaceutical industry has filed a second complaint with the European Commission against national legislation allowing the off-label use of cheaper medicines where approved alternatives exist, for purely financial reasons 1 . The ...

01 September 2015

Click on the links to access the documents. Country Organization Document Status China CFDA Guideline for Technical Review of Medical Device Software Registration (Chinese language) Final EU EC Consultation Document - Good Manufacturing ...

01 September 2015

It may be years before the US Food and Drug Administration officially begins implementing its proposal to add a suffix to the nonproprietary names of biologics that already are approved. However sponsors still may want to submit requested suffixes ...

01 September 2015

As groups and bodies with an interest in drug development increasingly recognize the benefits of incorporating the views of patients in their decision-making processes, work is under way to develop guidelines on how patient organizations should ...

01 September 2015

The European pharmaceutical industry has filed a second complaint with the European Commission against national legislation allowing the off-label use of cheaper medicines where approved alternatives exist, for purely financial reasons 1 . The ...

01 September 2015

Click on the links to access the documents. Country Organization Document Status China CFDA Guideline for Technical Review of Medical Device Software Registration (Chinese language) Final EU EC Consultation Document - Good Manufacturing ...

01 September 2015

It may be years before the US Food and Drug Administration officially begins implementing its proposal to add a suffix to the nonproprietary names of biologics that already are approved. However sponsors still may want to submit requested suffixes ...

01 September 2015

As groups and bodies with an interest in drug development increasingly recognize the benefits of incorporating the views of patients in their decision-making processes, work is under way to develop guidelines on how patient organizations should ...

01 September 2015

The European pharmaceutical industry has filed a second complaint with the European Commission against national legislation allowing the off-label use of cheaper medicines where approved alternatives exist, for purely financial reasons 1 . The ...

01 September 2015

Click on the links to access the documents. Country Organization Document Status China CFDA Guideline for Technical Review of Medical Device Software Registration (Chinese language) Final EU EC Consultation Document - Good Manufacturing ...

01 September 2015

It may be years before the US Food and Drug Administration officially begins implementing its proposal to add a suffix to the nonproprietary names of biologics that already are approved. However sponsors still may want to submit requested suffixes ...

01 September 2015

As groups and bodies with an interest in drug development increasingly recognize the benefits of incorporating the views of patients in their decision-making processes, work is under way to develop guidelines on how patient organizations should ...

01 September 2015

The European pharmaceutical industry has filed a second complaint with the European Commission against national legislation allowing the off-label use of cheaper medicines where approved alternatives exist, for purely financial reasons 1 . The ...

24 August 2015

The European Medicines Agency and the Heads of Medicines Agencies have published a "road map" describing the implementation plans for the EU'stelematics strategy, which is intended to help improve the efficiency of Europe's medicines regulatory ...

21 August 2015

Australia's Pharmaceutical Benefits Advisory Committee has recommended that Hospira's biosimilar Inflectra (infliximab) - which has only just been approved as the country's first biosimilar monoclonal antibody - should be listed on the ...

19 August 2015

A tool developed by the US National Cancer Institute to assess adverse events from cancer drugs from the point-of-view of patients has worked well in a large new study, paving the way for greater use in oncology trials and for incorporation into ...

25 August 2015

Amgen and Sandoz have both filed petitions asking the US Court of Appeals for the Federal Circuit to rehear a panel ruling interpreting the provisions of the biosimilars statute. Amgen argues against the finding that the information exchange process ...

22 July 2015

Biosimilar sponsors won a partial victory in the battle over the meaning of the US biosimilars statute as an appeals court found that the patent exchange process laid out in the law is optional 1 . But avoiding the disclosure and negotiation ...

22 June 2015

Another European court ruling has confirmed the important role of the EU orphan drug regulation in encouraging companies to conduct R&D into medicines for rare diseases, and helped to clarify the rules regarding the orphan market exclusivity ...

 
21 July 2015
Ashley Yeo
The height of summer in Europe it may be, but EU medtech industry leaders are not giving way to the holiday feeling just yet - not with the resumption of high level talks on the proposed Medical Device Regulation and sister IVD Regulation just ...
 
07 July 2015
Maureen Kenny
Regulators face a difficult balancing act in the debate over how to get innovative medicines to ...
 
20 August 2015
Vibha Sharma reports on a webinar that explained how medical device makers can make the most of ...
19 August 2015
The Council of the European Union?s agreed amendments to the requirements for clinical evaluation ...
06 August 2015
A UK departure from the EU could deprive pharmaceutical companies of the advantages offered by ...
 
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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 ...
 
The EMA at 20, what's it all about?
17 April 2015
 
EU electromedical industry association COCIR gets new president The European radiological, electromedical and healthcare IT industry association, COCIR, has appointed Joost Leeflang from ...
New MITA regulatory director to promote imaging standards adoption The US Medical Imaging & Technology Alliance has appointed Megan Hayes as its regulatory and standards director 1 . In her ...
 
   
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