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03 September 2014

 
02 September 2014

A policy change the US Food and Drug Administration is proposing in the medical devices arena could have a devastating effect on emerging companies, with particularly drastic implications for sponsors of devices subject to 510(k) clearance. That is ...

02 September 2014

The global generics industry is continuing its fight to achieve parity with the research-based pharmaceutical industry at the International Conference on Harmonisation, protesting that it refuses to be relegated to the side lines in the key global ...

02 September 2014

The US National Institutes of Health has issued a final policy about sharing genomic data, which will apply to all federal government-funded large-scale human and non-human projects that generate such information, including research conducted with ...

01 September 2014

The Brazilian regulatory agency, Anvisa, has drawn up two sets of proposals for streamlining and accelerating the processes for approving applications to conduct clinical trials of new drugs and medical devices. The proposals are open for public ...

02 September 2014

A policy change the US Food and Drug Administration is proposing in the medical devices arena could have a devastating effect on emerging companies, with particularly drastic implications for sponsors of devices subject to 510(k) clearance. That is ...

02 September 2014

The global generics industry is continuing its fight to achieve parity with the research-based pharmaceutical industry at the International Conference on Harmonisation, protesting that it refuses to be relegated to the side lines in the key global ...

02 September 2014

The US National Institutes of Health has issued a final policy about sharing genomic data, which will apply to all federal government-funded large-scale human and non-human projects that generate such information, including research conducted with ...

01 September 2014

The Brazilian regulatory agency, Anvisa, has drawn up two sets of proposals for streamlining and accelerating the processes for approving applications to conduct clinical trials of new drugs and medical devices. The proposals are open for public ...

02 September 2014

A policy change the US Food and Drug Administration is proposing in the medical devices arena could have a devastating effect on emerging companies, with particularly drastic implications for sponsors of devices subject to 510(k) clearance. That is ...

02 September 2014

The global generics industry is continuing its fight to achieve parity with the research-based pharmaceutical industry at the International Conference on Harmonisation, protesting that it refuses to be relegated to the side lines in the key global ...

02 September 2014

The US National Institutes of Health has issued a final policy about sharing genomic data, which will apply to all federal government-funded large-scale human and non-human projects that generate such information, including research conducted with ...

01 September 2014

The Brazilian regulatory agency, Anvisa, has drawn up two sets of proposals for streamlining and accelerating the processes for approving applications to conduct clinical trials of new drugs and medical devices. The proposals are open for public ...

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 ...
 
29 August 2014
The UK Intellectual Property Office has rejected two applications for supplementary protection ...
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 ...
 
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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