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RECENT TWEETS    
01 August 2015

 
31 July 2015

In view of the growing consensus that the views of patients should be incorporated in drug development and evaluation decisions, the Innovative Medicines Initiative is offering ?12 million in EU funding for a project to explore the specifics of this ...

31 July 2015

US medtech industry association AdvaMed is urging the Food and Drug Administration to expand the scope of its draft guideline on extrapolating existing clinical data to support medical device approvals for pediatric population so that it also covers ...

31 July 2015

In an important advance toward continual improvement of global pharmaceutical manufacturing processes, a Japanese regulatory official has promised that his agency will make it possible to use comparability protocols in Japan. Comparability protocols ...

30 July 2015

The International Medical Device Regulators Forum is inviting feedback on proposed common data elements that may be used to identify a medical device throughout its lifespan 1 . The proposed data elements, when finalized, may be used through various ...

31 July 2015

In view of the growing consensus that the views of patients should be incorporated in drug development and evaluation decisions, the Innovative Medicines Initiative is offering ?12 million in EU funding for a project to explore the specifics of this ...

31 July 2015

US medtech industry association AdvaMed is urging the Food and Drug Administration to expand the scope of its draft guideline on extrapolating existing clinical data to support medical device approvals for pediatric population so that it also covers ...

31 July 2015

In an important advance toward continual improvement of global pharmaceutical manufacturing processes, a Japanese regulatory official has promised that his agency will make it possible to use comparability protocols in Japan. Comparability protocols ...

30 July 2015

The International Medical Device Regulators Forum is inviting feedback on proposed common data elements that may be used to identify a medical device throughout its lifespan 1 . The proposed data elements, when finalized, may be used through various ...

31 July 2015

In view of the growing consensus that the views of patients should be incorporated in drug development and evaluation decisions, the Innovative Medicines Initiative is offering ?12 million in EU funding for a project to explore the specifics of this ...

31 July 2015

US medtech industry association AdvaMed is urging the Food and Drug Administration to expand the scope of its draft guideline on extrapolating existing clinical data to support medical device approvals for pediatric population so that it also covers ...

31 July 2015

In an important advance toward continual improvement of global pharmaceutical manufacturing processes, a Japanese regulatory official has promised that his agency will make it possible to use comparability protocols in Japan. Comparability protocols ...

30 July 2015

The International Medical Device Regulators Forum is inviting feedback on proposed common data elements that may be used to identify a medical device throughout its lifespan 1 . The proposed data elements, when finalized, may be used through various ...

29 July 2015

Drug makers miss the US Food and Drug Administration's 15-day deadline 10% of the time for reporting deaths, life-threatening side effects and other serious or unexpected adverse events (AEs) related to their medicines, researchers said on 27 July ...

14 July 2015

Japan's health ministry and healthcare products regulator agency have formally joined the pilot phase of the international medical device single audit program (MDSAP) 1 . Until now, the country's Ministry of Health, Labour and Welfare and the ...

10 July 2015

The European Medicines Agency has started publishing the outcomes of single assessments of periodic safety update reports (PSURs) for active substances that are only present in nationally-authorized medicines 1 ,2 . The EMA is advising companies ...

08 July 2015

Health Canada has issued final guidance explaining the steps that drug sponsors should follow when submitting a Canadian risk management plan in the European or other recognized formats 1 . The guidance also explains how sponsors should follow-up on ...

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 ...

11 June 2015

Before applying for an interim injunction in the UK, pharmaceutical companies may want to take note of a recent Court of Appeal ruling that upheld a 27m damages award made to Krka and Consilient in compensation for delays to the launch of their ...

 
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 July 2015
mHealth increasingly plays a part in delivering and optimizing patient care in the EU but there is ...
23 June 2015
Ariye Sidi explains how the approval process for clinical trials in Brazil has improved over the ...
22 June 2015
Thomas Hirse and Shuna Mason consider the regulatory and practical requirements for pharmaceutical ...
 
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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 ...
 
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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