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30 August 2015

 
28 August 2015

The World Health Organization is making progress on developing a revised model regulatory framework for medical devices for national agencies that face resource constraints or have yet to develop or implement device regulations in their respective ...

28 August 2015

The US Food and Drug Administration wants all biologics, including biosimilars, to carry a unique four-letter suffix as part of the nonproprietary names (INNs) of the active drug substance, the agency revealed on Aug. 27 in a draft guidance document ...

27 August 2015

The European Medicines Agency is extending an ongoing pilot project in which it invites patients to take part in certain meetings that its human medicines committee, the CHMP, holds to discuss the benefits and risks of drugs. So far, there have ...

27 August 2015

It appears that the US Food and Drug Administration?s long-awaited biosimilar naming convention may be revealed soon now that it has cleared White House review. But it must travel the much tougher road of notice and comment rulemaking for final ...

28 August 2015

The World Health Organization is making progress on developing a revised model regulatory framework for medical devices for national agencies that face resource constraints or have yet to develop or implement device regulations in their respective ...

28 August 2015

The US Food and Drug Administration wants all biologics, including biosimilars, to carry a unique four-letter suffix as part of the nonproprietary names (INNs) of the active drug substance, the agency revealed on Aug. 27 in a draft guidance document ...

27 August 2015

The European Medicines Agency is extending an ongoing pilot project in which it invites patients to take part in certain meetings that its human medicines committee, the CHMP, holds to discuss the benefits and risks of drugs. So far, there have ...

27 August 2015

It appears that the US Food and Drug Administration?s long-awaited biosimilar naming convention may be revealed soon now that it has cleared White House review. But it must travel the much tougher road of notice and comment rulemaking for final ...

28 August 2015

The World Health Organization is making progress on developing a revised model regulatory framework for medical devices for national agencies that face resource constraints or have yet to develop or implement device regulations in their respective ...

28 August 2015

The US Food and Drug Administration wants all biologics, including biosimilars, to carry a unique four-letter suffix as part of the nonproprietary names (INNs) of the active drug substance, the agency revealed on Aug. 27 in a draft guidance document ...

27 August 2015

The European Medicines Agency is extending an ongoing pilot project in which it invites patients to take part in certain meetings that its human medicines committee, the CHMP, holds to discuss the benefits and risks of drugs. So far, there have ...

27 August 2015

It appears that the US Food and Drug Administration?s long-awaited biosimilar naming convention may be revealed soon now that it has cleared White House review. But it must travel the much tougher road of notice and comment rulemaking for final ...

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 ...

18 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 ...

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 ...
 
 
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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