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The European Society of Radiology (ESR) and the European Federation of Neurological Associations last month announced the launch of the Alliance for MRI to stop European Union (EU) legislation from inadvertently preventing the use of magnetic resonance imaging (MRI).
Sponsors wishing to test high-risk new drugs for the first time on human subjects are advised to undertake additional preliminary studies in some circumstances under a new draft guideline from the European Medicines Agency (EMEA).
The European Medicines Agency (EMEA) has released for comment draft guidance on acceptable limits of metal residues in drug substances and excipients (inert substances that aid in binding a pill or tablet).
The European Medicines Agency (EMEA) recommended adding a warning for patients and doctors about Roche’s flu drug Tamiflu after the agency learned of new reports of neuropsychiatric adverse events occurring with the use of Tamiflu in Japan.
Hungary's National Institute of Pharmacy considers all medical investigations carried out on human beings to be clinical trials if they are done with the purpose of gathering information about one or more medicinal products.
The European Union (EU) and Japan have signed an agreement permitting the exchange of confidential information about the authorization and safety of medicines.
Sponsors beginning clinical trials in France before May 1, 2004, were advised to follow the French Huriet Law of Dec. 20, 1988, as amended, for the protection of persons involved in biomedical research.
The European Medicines Agency (EMEA) has granted Roche an accelerated review of its flu drug Tamiflu. The company said it “is optimistic that EMEA will complete their evaluation by midyear.”
A recent trend among some European Union (EU) members to apply clinical trial regulations for medicines to medical devices is ill-conceived and not in the interest of device manufacturers, according to a position paper released by Eucomed, the European medical technology industry association.