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02 June 2015

 
01 June 2015

Pharmaceutical and medical technology companies operating in Brazil can expect to see the implementation of additional measures relating to anti-bribery rules in the country. Following the Clean Companies Act, which came into effect in January 2014 ...

01 June 2015

The US Food and Drug Administration has urged dermal filler firms to update labeling to warn of rare but serious complications that can occur when the soft tissue products are unintentionally injected into facial blood vessels in conjunction with a ...

01 June 2015

The EU Heads of Medicines Agencies has endorsed plans to test a new risk-based model for identifying human and veterinary medicinal products that could be subjected to laboratory testing in the post-authorization phase under ongoing surveillance ...

29 May 2015

The China Food and Drug Administration has for the first time issued guidance that explains how medical device makers should conduct clinical evaluations of the products they seek to register in China and in which cases they may obtain a clinical ...

01 June 2015

Companies seeking to register Class II and III medical devices for sale in China now have to start paying fees amounting to tens of thousands of US dollars to the China Food and Drug Administration 1 ,2 . Neither domestic nor foreign medical device ...

01 June 2015

Pharmaceutical and medical technology companies operating in Brazil can expect to see the implementation of additional measures relating to anti-bribery rules in the country. Following the Clean Companies Act, which came into effect in January 2014 ...

01 June 2015

The US Food and Drug Administration has urged dermal filler firms to update labeling to warn of rare but serious complications that can occur when the soft tissue products are unintentionally injected into facial blood vessels in conjunction with a ...

01 June 2015

The EU Heads of Medicines Agencies has endorsed plans to test a new risk-based model for identifying human and veterinary medicinal products that could be subjected to laboratory testing in the post-authorization phase under ongoing surveillance ...

01 June 2015

Companies seeking to register Class II and III medical devices for sale in China now have to start paying fees amounting to tens of thousands of US dollars to the China Food and Drug Administration 1 ,2 . Neither domestic nor foreign medical device ...

01 June 2015

The US Food and Drug Administration has urged dermal filler firms to update labeling to warn of rare but serious complications that can occur when the soft tissue products are unintentionally injected into facial blood vessels in conjunction with a ...

01 June 2015

The EU Heads of Medicines Agencies has endorsed plans to test a new risk-based model for identifying human and veterinary medicinal products that could be subjected to laboratory testing in the post-authorization phase under ongoing surveillance ...

29 May 2015

The China Food and Drug Administration has for the first time issued guidance that explains how medical device makers should conduct clinical evaluations of the products they seek to register in China and in which cases they may obtain a clinical ...

01 June 2015

Pharmaceutical and medical technology companies operating in Brazil can expect to see the implementation of additional measures relating to anti-bribery rules in the country. Following the Clean Companies Act, which came into effect in January 2014 ...

28 May 2015

The German government is currently in the final stages of deliberating a new draft law aimed at eradicating bribery in the healthcare sector, a law that - once enacted - will create particular challenges for medical device companies. The Federal ...

27 May 2015

The EU generics industry says that while a new initiative that aims to help drug makers in the EU, especially generics companies, prepare risk management plans is a step in the "right direction", "further steps" are needed to ensure that the ...

27 May 2015

The US Food and Drug Administration is delaying until 8 September the deadline for companies to comply with a requirement to electronically submit post-marketing individual case safety reports (ICSRs) of adverse events linked to drugs and biologics ...

01 June 2015

Pharmaceutical and medical technology companies operating in Brazil can expect to see the implementation of additional measures relating to anti-bribery rules in the country. Following the Clean Companies Act, which came into effect in January 2014 ...

05 May 2015

For the US, India remains on the "priority watch list" of countries that presents the most significant intellectual property rights (IPR)-related concerns. However, it has been spared another immediate out-of-cycle review (OCR) in view of steps ...

23 April 2015

The Court of Justice of the European Union has been asked to decide whether medical device notified bodies can be held liable for patient safety if they fail to detect misconduct by a device manufacturer whose products they evaluated 1 . Should the ...

 
02 April 2015
Ian Schofield
News that the French regulatory agency ANSM has formally launched an internal inquiry into claims that former members of two committees responsible for decisions on drug approval and reimbursement held secret meetings with pharmaceutical companies ...
 
07 November 2014
Maureen Kenny
The appointment of Professor Sir Michael Rawlins as chair of the UK Medicines and Healthcare ...
 
20 May 2015
Patent expiries, pricing pressures and the emergence of approval pathways in countries such as ...
14 April 2015
Adam Sherlock discusses a recent life science industry survey that shows how companies are ...
02 April 2015
Daniel Kracov and Rosemary Maxwell explain how the 21 st Century Cures initiative proposes to ...
 
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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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