France's drug regulatory agency, Afssaps , has published details of the new membership of its various bodies and committees, including those responsible for drug approvals and pharmacovigilance 1 ,2 . The move is noteworthy because the ...
The US Food and Drug Administration has released the results of a study that was conducted in support of the agency's plans to establish standards for drug sponsors with regard to communicating a medicine's side effects clearly in TV advertisements ...
Health Canada has issued final guidance on different types of submissions relating to implantable cardiac leads 1 . The guideline, which comes into effect on 25 October, aims to help manufacturers of implantable cardiac leads prepare applications ...
The UK BioIndustry Association and the Association of the British Pharmaceutical Industry are to jointly relocate to new central London offices later this month. The move is expected to "help enhance the UK's competitive position in life sciences, ...
The European Medicines Agency 's Committee for Advanced Therapies has put considerable effort into developing guidelines to explain how it operates. But has the CAT's apparent success in achieving its goals resulted in a labyrinth of guidance so ...
Only one new advanced therapy medicinal product application was submitted to the European Medicines Agency's Committee for Advanced Therapies in its second year of operation, says the agency's 2010 annual report 1 . The CAT deals with ATMPs that ...
The European Medicines Agency 's proposed revised version of its guidance concerning the CE marking of drug/device combination products will not improve the length of the procedure nor the related costs, says European medtech trade association ...
The UK Medicines and Healthcare Products Agency has revised its guidance for notified bodies wanting to consult the agency with regard to medical devices incorporating ancillary medicinal substances 1 ,2 . The latest document replaces an earlier ...
Pharmaceutical companies are being invited to test a common platform in Europe for submitting electronic marketing applications that has been developed under the remit of the EU Heads of Medicines Agencies 1-2 . The Common European Submission ...
With warning letters and other regulatory action by the US Food and Drug Administration hitting an all-time high, it's a good time to reflect and ask what we can learn from the mistakes of others, says Martin Lush . From the moment a company ...
A new guideline from the European Commission represents the first single, collated document to shed light on the role of the medical device authorised representative, the EU-based person or a body that medical device manufacturers need to have if ...
The World Trade Organization 's Committee on Technical Barriers to Trade (TBT) has issued formal notifications of two draft legislation concerning the Brazilian medtech sector 1 ,2 . The notifications are dated 13 January and relate to proposed ...
From next May, the Brazilian in vitro diagnostics market will be subject to new regulations 1 ,2 . The most important changes will be to the product classification system and how product risk is determined. The reforms introduce a simpler and ...
