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.’
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
The International Council for Harmonisation has developed a holistic approach for the assessment and control of leachable impurities, supporting drug product development, registration and ongoing quality management throughout the product lifecycle.
