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28 July 2010

A non-governmental organisation has published guidance that it says will give companies a "head-start" in meeting the challenges of complying with the provisions of the UK Bribery Act, which comes into force in April 2011 1-3 . Transparency ...

15 July 2010

The US Food and Drug Administration should, as far as possible, rely on existing standards to achieve the objectives of its "home-use" initiative, which aims to assure the safe use of medical devices in patients' homes, says medtech industry ...

22 June 2010

The US Supreme Court has agreed to review Matrixx Initiatives Inc v Siracusano, a case that has the potential to determine which adverse event reports drug and medical device companies must disclose to shareholders to avoid securities suits 1 . ...

08 July 2009

The US Food and Drug Administration is developing guidance for contact lens manufacturers on potential labelling improvements for contact lens care products 1 . Also, the FDA has developed a new video on contact lens safety for consumers that ...

26 May 2009

Health Canada , in response to reports of inaccurate temperature readings from infrared thermometers, is asking manufacturers to strengthen their product labelling by including extra information in the directions for use 1 . Effective as of May 21, ...

06 July 2010

The Australian government has published two consultation papers with the aim of setting up a more streamlined, efficient and transparent approach to the self-regulation of medicines and medical devices promotion to healthcare professionals in the ...

05 July 2010

As doctors in the US brace themselves for the 30 million new patients that the new healthcare reform law promises to channel into the system, a key mechanism for advancing their medical knowledge and performance is facing tumultuous times. Certified ...

28 July 2010

A non-governmental organisation has published guidance that it says will give companies a "head-start" in meeting the challenges of complying with the provisions of the UK Bribery Act, which comes into force in April 2011 1-3 . Transparency ...

21 July 2010

The UK Bribery Act, which was signed into law earlier this year, will come into force in April 2011, the Ministry of Justice has announced 1 ,2 . Its implementation is expected to pave the way for fairer practice by encouraging companies to adopt ...

 
06 July 2010
Ashley Yeo
The European Medicines Agency review meeting in London on 30 June passed with scarcely a mention of devices and diagnostics. This was perhaps as expected, given that the meeting, held to examine the outcomes of the assessment of Ernst & Young's ...
 
02 July 2010
On tenterhooks over the US Food and Drug Administration's reform of the 510(k) review process, the US medical technology industry is warning that the ...
 
06 July 2010
Tony Lewis and Alison Dennis urge medical device companies to review their compliance policies ahead of the Act's entry into force. The UK Bribery ...
02 July 2010
On tenterhooks over the US Food and Drug Administration's reform of the 510(k) review process, the US medical technology industry is warning that the ...
19 May 2010
It is “staggering” how many manufacturers fail to fully fulfil their legal responsibility to collect product data in the post-production phase, ...
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, July 2010
19 July 2010
 
 
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