The US Food and Drug Administration has announced that it intends to regulate electronic cigarettes as medical products and that these will be deemed combination products and be subject to the agency's drug rules 1 ,2 . The FDA's statement on 9 ...

The World Health Organization's inaugural Global Forum on Medical Devices, which began on 9 September in Bangkok, Thailand, promises a breakthrough in improving access to medical technology globally 1,2 . The World Health Organization (WHO) has ...

The UK Medicines and Healthcare products Regulatory Agency has reported that the preliminary tests it has conducted on the silicone filler used in banned breast implants made by Poly Implant Prothèse (PIP) have revealed “no evidence of genotoxicity ...

The US Supreme Court is being urged to overturn an appeals court decision that held that life sciences companies could be sued under the Securities Exchange Act for not publicly disclosing scattered adverse event reports about their products, even ...

Orthopaedics firm DePuy has voluntarily recalled two of its hip replacement products, after post-market surveillance data showed a high risk of revision rates for patients implanted with the devices 1 . The company said it had notified the US Food ...

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 ...

The Australian Senate has extended until 2 September the reporting time for its inquiry into the how the granting of gene patents is impacting the healthcare system 1 . The inquiry, by the Senate's Community Affairs Committee, requires the extension ...

The European Medicines Agency has released for consultation guidance on how the agency's Committee for Advanced Therapies will interact with notified bodies when the committee assesses combination advanced therapy medicinal products that incorporate ...

The European Medicines Agency has released for consultation guidance on how the agency's Committee for Advanced Therapies will interact with notified bodies when the committee assesses combination advanced therapy medicinal products that incorporate ...

The US Food and Drug Administration has announced that it intends to regulate electronic cigarettes as medical products and that these will be deemed combination products and be subject to the agency's drug rules 1 ,2 . The FDA's statement on 9 ...

The US Supreme Court is being urged to overturn an appeals court decision that held that life sciences companies could be sued under the Securities Exchange Act for not publicly disclosing scattered adverse event reports about their products, even ...

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 ...

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 ...

Orthopaedics firm DePuy has voluntarily recalled two of its hip replacement products, after post-market surveillance data showed a high risk of revision rates for patients implanted with the devices 1 . The company said it had notified the US Food ...

The Irish Medicines Board has issued a general advisory explaining the importance of establishing and managing effective traceability systems for medical devices in all healthcare settings 1 . The advisory, issued as a safety notice, offers ...

Spain has adopted a new law that strengthens its existing provisions on criminal liability and will apply to crimes such as fraud, bribery and commercial bribery 1 ,2 . The law enters into force in December 2010. According to law firm Baker & ...

New Zealand's regulatory agency Medsafe is planning to deliver an updated version of its Uniform Recall Procedure for Medicines and Medical Devices (known as the Recall Code) by the end of September 2010 and has issued for consultation draft ...

Just when it seemed it was finally on the home straight, the proposal for a single European Union patent and a unified European patent court looks like hitting another major hurdle after a leaked opinion from the European Court of Justice said that ...

A US court has been urged to revamp the inequitable conduct doctrine, a commonly used provision in patent litigation that allows the validity of a patent to be challenged if one is able to establish that, at the time of applying for a patent, the ...

The Australian Senate has extended until 2 September the reporting time for its inquiry into the how the granting of gene patents is impacting the healthcare system 1 . The inquiry, by the Senate's Community Affairs Committee, requires the extension ...

The US Supreme Court has ruled that the so-called "machine-or-transformation" test is not the only way to determine the patentability of a new method 1 . The test required a patentable process to be either tied to a machine or apparatus or to ...