FDA objects to eight-page journal ad for Pfizer's Lipitor (atorvastatin) in July 12 letter on the grounds that it implies a claim for the off-label indication of prevention of coronary heart disease. Ad depicts "apparent candidates for Lipitor" wearing nametags saying they have hyperlipidemia and another coronary heart disease risk factor, agency notes. The ad "creates an overwhelming impression that Lipitor is indicated to reduce the risk of developing coronary heart disease," FDA concludes. Atorvastatin is not approved for that claim. Pfizer discontinued the ad and plans to introduce a new journal ad
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.