Email ID
Password
Sign me in automatically next time
RECENT TWEETS    
28 May 2015

 
28 May 2015

Device manufacturers in the US anticipate a new Food and Drug Administration guidance document soon on the criteria the agency uses to determine whether an advisory panel meeting is required to support a premarket review decision. The impact of ...

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 Australian government is pressing ahead with plans to allow pharmacist substitution of biosimilars after the Pharmaceutical Benefits Advisory Committee outlined the criteria that would have to be met if substitution was to take place 1 . The ...

27 May 2015

Last year, EU notified bodies withdrew over 1,000 certificates awarded to medical device companies for reasons including non-compliance, major non-conformities and refusal of device manufacturers to undergo an audit, according to a survey conducted ...

28 May 2015

Device manufacturers in the US anticipate a new Food and Drug Administration guidance document soon on the criteria the agency uses to determine whether an advisory panel meeting is required to support a premarket review decision. The impact of ...

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

Last year, EU notified bodies withdrew over 1,000 certificates awarded to medical device companies for reasons including non-compliance, major non-conformities and refusal of device manufacturers to undergo an audit, according to a survey conducted ...

27 May 2015

Developers of gene therapies tend not to be familiar with the regulatory environment and so the European Medicines Agency is trying a new approach aimed at addressing their needs in a new draft guideline aimed at supporting and facilitating the ...

27 May 2015

Last year, EU notified bodies withdrew over 1,000 certificates awarded to medical device companies for reasons including non-compliance, major non-conformities and refusal of device manufacturers to undergo an audit, according to a survey conducted ...

27 May 2015

Developers of gene therapies tend not to be familiar with the regulatory environment and so the European Medicines Agency is trying a new approach aimed at addressing their needs in a new draft guideline aimed at supporting and facilitating the ...

26 May 2015

Developers of gene therapies tend not to be familiar with the regulatory environment and so the European Medicines Agency is trying a new approach aimed at addressing their needs in a new draft guideline aimed at supporting and facilitating the ...

22 May 2015

There is no respite for GVK Biosciences, the Indian contract research organization in the eye of a storm over allegations of data manipulation by European regulators. The European Medicines Agency said today it was sticking with its previous ...

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 ...

26 May 2015

Finland's Fimea has become the latest national regulatory agency in the EU to issue a formal statement supporting the switching of patients from a reference biological product to a biosimilar version ? and vice versa ? on the grounds that there is ...

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 ...

23 March 2015

A US District Court has ruled that Novartis unit Sandoz did nothing wrong by not engaging in the disclosure and dispute resolution process laid out by the Biologics Price Competition and Innovation Act ? the law that established the abbreviated ...

 
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 ...
 
 
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 ...
 
   
© 2015 Informa plc. All rights reserved.
This site is owned and operated by Informa plc ("Informa") whose registered office is Mortimer House, 37-41 Mortimer Street, London, W1T 3JH. Registered in England and Wales. Number 3099067. UK VAT Group: GB 365 4626 36