The European Food Safety Authority gave most health claims in the second wave of evaluations unfavorable opinions "due to the poor quality of the information provided," EFSA says Feb. 25. The authority's Panel on Dietetic Products, Nutrition and Allergies cited insufficient information to identify substances and insufficient evidence that claimed effects benefit the body. Many of the 416 claims evaluated were not supported by human studies with reliable measures, EFSA said. The panel sent its opinions to the European Commission and EU members, which will decide whether to authorize the claims. Industry stakeholders complain EFSA set the bar too high for many claims in its evaluation process, slated for completion by 2011 (1"The Tan Sheet" Jan. 11, 2010)
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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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Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.