Antioxidant claims basis for FDA suit: In his third lawsuit filed against FDA in less than a month, attorney Jonathan Emord alleges FDA "created a rigid construct that categorically rejects a large quantum of peer-reviewed science," namely qualified health claims linking antioxidant vitamins C and E with reduced risk of site-specific cancers. Emord's 1complaint, filed Aug. 14 in the U.S. District Court for the District of Columbia, says FDA violated First Amendment-based precedent in denying the claims for which he petitioned in 2008. As with the similar recent suit Emord filed against FDA for rejecting selenium QHCs, the Clifton, Va.-based attorney represents the Alliance for Natural Health U.S., the Coalition to End FDA and FTC Censorship, and businesspeople Durk Pearson and Sandy Shaw (2"The Tan Sheet" Aug. 3, 2009, In Brief)
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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 White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
