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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
