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23 August 2014

 
22 August 2014

The International Conference on Harmonisation is working on establishing general principles on how sponsors can plan and design multi-regional clinical trials so as to facilitate the acceptance of data from such studies by multiple regulatory ...

22 August 2014

Building on its ongoing efforts to help medical device labelers comply with the imminent US requirements on unique device identification (UDI), the Food and Drug Administration has issued a Q&A document that addresses questions it frequently ...

22 August 2014

The European Commission has responded rapidly to the posting by the International Medical Device Regulators Forum of final market authorization tables of contents (ToC) for medical devices and IVDs. These documents 1 , published on the IMDRF's ...

21 August 2014

In response to a congressional mandate, and years of criticism, the US Food and Drug Administration on 20 August committed to taking 27 actions aimed at improving the completeness and quality of demographic subgroup data collected, reported and ...

22 August 2014

The International Conference on Harmonisation is working on establishing general principles on how sponsors can plan and design multi-regional clinical trials so as to facilitate the acceptance of data from such studies by multiple regulatory ...

22 August 2014

Building on its ongoing efforts to help medical device labelers comply with the imminent US requirements on unique device identification (UDI), the Food and Drug Administration has issued a Q&A document that addresses questions it frequently ...

22 August 2014

The European Commission has responded rapidly to the posting by the International Medical Device Regulators Forum of final market authorization tables of contents (ToC) for medical devices and IVDs. These documents 1 , published on the IMDRF's ...

21 August 2014

In response to a congressional mandate, and years of criticism, the US Food and Drug Administration on 20 August committed to taking 27 actions aimed at improving the completeness and quality of demographic subgroup data collected, reported and ...

22 August 2014

The International Conference on Harmonisation is working on establishing general principles on how sponsors can plan and design multi-regional clinical trials so as to facilitate the acceptance of data from such studies by multiple regulatory ...

22 August 2014

The European Commission has responded rapidly to the posting by the International Medical Device Regulators Forum of final market authorization tables of contents (ToC) for medical devices and IVDs. These documents 1 , published on the IMDRF's ...

21 August 2014

In response to a congressional mandate, and years of criticism, the US Food and Drug Administration on 20 August committed to taking 27 actions aimed at improving the completeness and quality of demographic subgroup data collected, reported and ...

20 August 2014

US lawmakers on 19 August were urged to pass a bill aimed at encouraging the development of drugs abandoned during the R&D process, improve the clinical trial matching and selection process and create an economic solution for industry to repurpose ...

22 August 2014

Building on its ongoing efforts to help medical device labelers comply with the imminent US requirements on unique device identification (UDI), the Food and Drug Administration has issued a Q&A document that addresses questions it frequently ...

07 August 2014

The World Health Organization is inviting feedback on proposed procedures and data requirements relating to changes companies make to approved prophylactic vaccines for humans 1 . The WHO's proposals are listed in a draft guideline that explains ...

06 August 2014

The European Medicines Agency is planning to expand and enhance its policy on access to EudraVigilance so that the EU drug safety database can be of better use to both medicines companies endeavoring to meet their pharmacovigilance obligations and ...

29 July 2014

Roche says it is considering whether to appeal against a recent UK judgment that dismissed its complaints over the way the Medicines and Healthcare Products Regulatory Agency (MHRA) handled information about the drug company's alleged failure to ...

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 ...

14 August 2014

The US Food and Drug Administration is inviting feedback on its proposal for the data that makers of biological products would have to submit to the agency to qualify for a 12-year "reference product exclusivity" during which approval of a ...

 
20 August 2014
Peter Charlish
It is now over 20 years since the International Conference on Harmonisation issued its guideline on clinical studies of new medicines in geriatric populations. The guideline stated: "the use of drugs in this population requires special consideration ...
 
11 February 2014
Maureen Kenny
?If you don?t finance it correctly, it will implode.? This was the stark warning key European drug ...
 
21 August 2014
Fabienne Diekmann explains how things are changing for medtech under the new medical product ...
07 August 2014
Erick Gaussens discusses the coming Identification of Medicinal Product standards and explains why ...
10 July 2014
Paul Ranson and Helen Cline examine how the new EU adaptive licensing proposals could be ...
 
MOST READ
 
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
 
Onwards and upwards for Steven Galson at Amgen Steven Galson has had his responsibilities at Amgen expanded. The former director of the US Food and Drug Administration's ...
Howard Sklamberg, drugs compliance director at US FDA, takes on global role at agency Howard Sklamberg, the director of the Office of Compliance at the US Food and Drug Administration?s drugs center CDER, is ...
 
   
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