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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A new pilot aims to take Brazil closer to ‘digital transformation.’
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
