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03 September 2010

The new Australian regulatory framework for in vitro diagnostics has been published into law and will apply from 1 July. It provides a four-year transition period for IVDs under the current regulatory framework to comply with the new requirements ...

02 September 2010

The European Commission has issued a document clarifying certain legal obligations arising from the Customs Union Agreement that was signed between Turkey and the European Community for medical devices 1 ,2 . Specifically, the "interpretative ...

01 September 2010

India's regulatory agency for devices and drugs is seeking feedback on a draft guideline that explains the submission format for obtaining licences to import medical devices into the country 1 . The draft document from the Central Drugs Standard ...

23 July 2010

The medtech industry has expressed concern over draft proposals from the US Food and Drug Administration to disclose to public information on medical devices and drugs that have not yet been approved 1 . Disclosing information on pending device ...

11 May 2010

In a move that promises to improve the quality of communication of medical information and images via so-called fourth-generation mobile technology, the European Commission has adopted a decision establishing harmonised technical rules for member ...

06 May 2010

A new industry association comprised of Turkey’s top medtech companies is in the process of creating a robust code of ethics and pushing for regulatory updates. Altay Akbulut of Eczacibaşi-Baxter Hospital Supply spoke at the 2010 international ...

07 October 2009

The Irish Medicines Board , having found no takers for a new service it started last year to offer formal scientific advice on the drug component of drug/device combination products, is planning to charge a reduced fee for the job 1 ,2 . Reacting to ...

07 October 2009

The Human Fertilisation and Embryology Act 2008 came into force in the UK on 1 October 1 ,2 . The law ensures that all human embryos outside the body – whatever process used in their creation – are subject to regulation, said the Department of ...

01 October 2009

The US Food and Drug Administration , responding to concerns over the lack of specific postmarketing safety reporting requirements for combination products, has issued a much-awaited proposed rule to address the issue 1 . In addition to requiring ...

03 September 2010

The new Australian regulatory framework for in vitro diagnostics has been published into law and will apply from 1 July. It provides a four-year transition period for IVDs under the current regulatory framework to comply with the new requirements ...

02 September 2010

The European Commission has issued a document clarifying certain legal obligations arising from the Customs Union Agreement that was signed between Turkey and the European Community for medical devices 1 ,2 . Specifically, the "interpretative ...

01 September 2010

India's regulatory agency for devices and drugs is seeking feedback on a draft guideline that explains the submission format for obtaining licences to import medical devices into the country 1 . The draft document from the Central Drugs Standard ...

23 July 2010

The medtech industry has expressed concern over draft proposals from the US Food and Drug Administration to disclose to public information on medical devices and drugs that have not yet been approved 1 . Disclosing information on pending device ...

06 May 2010

A new industry association comprised of Turkey’s top medtech companies is in the process of creating a robust code of ethics and pushing for regulatory updates. Altay Akbulut of Eczacibaşi-Baxter Hospital Supply spoke at the 2010 international ...

29 January 2010

The European Commission , in its exploratory process on the future of medical devices, has revealed a consensus among stakeholders that there is a need to develop new tools and mechanisms to evaluate the impact of innovation on the sector 1 ,2 . In ...

28 January 2010

The European Commission , along with authorities in China, has upgraded an existing online platform that lists technical standards being used in the medical device and other sectors in the two markets 1 . The upgraded platform is expected to ...

23 November 2009

US healthcare facilities and manufacturers are being warned about the risks to patients if flexible endoscopes and their accessories are not properly processed. In a safety communication, the Food and Drug Administration , the Centers for Disease ...

20 October 2009

US biotech companies are worried that recommendations of a government task force on gene patenting and licensing, if implemented, could restrict the ability to obtain, or undermine the enforceability of, patents and exclusive licences with respect ...

15 October 2009

European companies operating in China remain concerned that confidential data submitted by them during patent filing, product registration and other stages of business development are leaked to their Chinese competitors 1 ,2 . While China has taken ...

12 October 2009

The US Patent and Trade Mark Office has withdrawn controversial rules issued by the previous administration that sought to limit the size of patent applications 1 . The rules were published in a Federal Register notice in August 2007; they were ...

05 October 2009

Member states of the World Intellectual Property Organization have agreed to streamline and simplify the existing international registration system for industrial designs from 2010 1 ,2 . The Hague Agreement Concerning the International Deposit of ...

 
29 January 2010
Ashley Yeo
The UK government and the life science industries have marked a year of action and progress for the Office for Life Sciences (OLS) with the release of a final report on its work to date and future plans. A lot has been written about the unique ...
 
12 March 2010
Karen Finn
The Asian Harmonization Working Party should be commended for taking the lead on resolving the issue of choosing a global medical device nomenclature system, and for the transparent way in which it is doing so. The organisation seemingly announces ...
 
MOST READ
 
23 July 2010
TÜV Product Service , one the main notified bodies for medical devices in the European Union, is in no doubt that the basic EU medtech regulatory ...
02 November 2009
Peter Charlish looks at the regulation of “e-cigarettes” and finds they can be drugs, devices, neither or both. Unless it is very tightly drawn up, ...
13 October 2009
Retta M Riordan examines manufacturers’ settlements with the government and provides advice on how to avoid prosecution. “Pfizer to pay record $2.3 ...
 
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
08 October 2009
1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain? Agencia Española del Medicamento, the ...
RAJ Devices News Roundup, 11 December 2009
11 December 2009
 
Robert Gregg joins OraSure US oral fluid diagnostics specialist OraSure Technologies has appointed Robert Gregg vice president of regulatory affairs and quality assurance. Dr Gregg will be responsible for the Bethlehem, Philadelphia-based firm’s regulatory, quality assurance ...
New CENELEC president named The Administrative Board of the European Committee for Electrotechnical Standardization ( CENELEC ) has named David Dossett president following the resignation with immediate effect of Dietmar Harting. Mr Dossett, who was vice president and ...
 
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