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.’
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.
An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.
