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30 September 2014

 
30 September 2014

Simply click on the links to access the documents. Country Organization Title Status Australia TGA Guidance 23: Nonclinical studies, Version 1.1 Final Australia TGA Adoption of EMA Guideline on process validation for finished products - ...

30 September 2014

Simply click on the links to access the documents. Country Organization Title Status International AHWP Adverse Event Reporting Timelines Guidance for Medical Device Manufacturer and its ...

30 September 2014

As pressure grows for a rethink of controversial plans to place pharmaceutical and medical device policy under the European Commission's industry directorate, Richard Bergström, head of the European pharmaceutical industry body EFPIA, says the new ...

30 September 2014

The first facility inspection relating to a globally marketed device has begun under the International Medical Device Regulators Forum's medical device single audit program (MDSAP). It has taken many years for device regulators to develop the idea ...

30 September 2014

Simply click on the links to access the documents. Country Organization Title Status Australia TGA Guidance 23: Nonclinical studies, Version 1.1 Final Australia TGA Adoption of EMA Guideline on process validation for finished products - ...

30 September 2014

Simply click on the links to access the documents. Country Organization Title Status International AHWP Adverse Event Reporting Timelines Guidance for Medical Device Manufacturer and its ...

30 September 2014

As pressure grows for a rethink of controversial plans to place pharmaceutical and medical device policy under the European Commission's industry directorate, Richard Bergström, head of the European pharmaceutical industry body EFPIA, says the new ...

30 September 2014

The first facility inspection relating to a globally marketed device has begun under the International Medical Device Regulators Forum's medical device single audit program (MDSAP). It has taken many years for device regulators to develop the idea ...

30 September 2014

The first facility inspection relating to a globally marketed device has begun under the International Medical Device Regulators Forum's medical device single audit program (MDSAP). It has taken many years for device regulators to develop the idea ...

29 September 2014

In a move intended to give patients more of a say in the evaluation of new drugs, the European Medicines Agency has begun a project under which patients will be invited to take part in certain benefit-risk discussions at meetings of its main ...

29 September 2014

The European Medicines Agency is hoping to get a final decision from its management board on 2 October on its eagerly-awaited policy on proactive publication of clinical trial data. If things go as planned, the policy could come into effect next ...

25 September 2014

European biotechnology industry body EuropaBio says that the labeling of biosimilar medicines should make clear whether the data used for their approval were generated for the biosimilar or its reference product, and should include information on ...

26 September 2014

The European pharmaceutical industry federation, EFPIA, is considering legal action against the Italian government over its decision to reimburse the off-label use of medicines for financial reasons 1 . Under a change made to Italian legislation in ...

22 September 2014

The US Food and Drug Administration's unique device identification (UDI) system will soon face arguably one of its most challenging milestones to date: By the end of September, makers of high-risk medical devices will officially be required to add ...

19 September 2014

The European Medicines Agency has issued new requirements on how drug companies should manage and report adverse reactions from non-interventional post-authorization safety studies. The requirements, which are outlined in a revised EMA guideline on ...

18 September 2014

The UK Medicines and Healthcare Products Regulatory Agency is inviting feedback from medical device manufacturers on its plans to introduce a fee for processing each certificate of free sale (CFS) application as of April 2015 1 . CFSs are currently ...

29 September 2014

The European Medicines Agency is hoping to get a final decision from its management board on 2 October on its eagerly-awaited policy on proactive publication of clinical trial data. If things go as planned, the policy could come into effect next ...

19 August 2014

The top court of the US state of Alabama has reaffirmed its decision last year that brand-name drug makers like Pfizer can be held liable for a lack of warnings on generic forms of their medicines. The ruling could have implications in other ...

15 August 2014

Europe's pharmaceutical industry body EFPIA has again set out its views on just how much clinical trial data should be shared with researchers and the public, this time in a blog entitled 'A 3D view of responsible clinical data sharing' that insists ...

 
15 September 2014
Ashley Yeo
A blissful summer - albeit now swiftly receding - free of political sparring over the European Commission's proposed twin medtech regulations? Or did you miss the duck and weave, the EU medtech industry being pummelled but still standing and coming ...
 
11 February 2014
Maureen Kenny
?If you don?t finance it correctly, it will implode.? This was the stark warning key European drug ...
 
29 September 2014
Erick Gaussens explains why pharmaceutical companies should make managing their affiliates a ...
25 September 2014
The US Food and Drug Administration's breakthrough therapy designation program for new drugs and ...
09 September 2014
As the September 24 deadline approaches for Class III medical device manufacturers to comply with ...
 
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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 ...
 
A candid look at the European drug regulatory network from Jytte Lyngvig, CEO of the Danish Medicines Agency 2000-2012
18 January 2013
 
US FDA's drugs center gets permanent regulatory policy head The US Food and Drug Administration has promoted Grail Sipes to permanent director of its Office of Regulatory Policy at ...
Law enforcement expert named as new compliance chief at US FDA drug center The US Food and Drug Administration has hired Cynthia Schnedar as the new head of compliance at its Center for Drug ...
 
   
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