The agency waits until publication of a final rule to enforce against firms making health claims linking free phytosterols in foods and dietary supplements with reduced risk of coronary heart disease. In a Federal Register notice prepared for Feb. 21 publication, FDA cites data and information currently under review and the need to focus its resources “on other public health priorities” as factors in the decision. The agency in 2003 established rules for the enforcement discretion and twice previously extended the deadline, most recently in February 2011 after multiple firms argued in comments that relabeling, reformulating and relaunching products to comply with the proposed rule could take nearly three years Also see "FDA Extends Enforcement Discretion On Free Phytosterol Health Claims" - Pink Sheet, 21 February, 2011..
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The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.