The final rule for dietary supplement good manufacturing practices is "poorly written and unnecessarily a trap for the unwary," asserts attorney Jonathan Emord in a 1complaint filed Aug. 7 against FDA. The GMPs violate the Dietary Supplement Health and Education Act by allowing the agency to hold products as adulterated without proving they present a public health risk, he says. Emord also claims that because firms are not given proper guidance for complying with GMPs, the rule violates the constitutional prohibition against vague laws. Like his July 30 suit regarding FDA's rejection of health claims, the Aug. 7 suit also was filed in the U.S. District Court for the District of Columbia and on behalf of the Alliance for Natural Health U.S., the Coalition to End FDA and FTC Censorship and supplement businesspersons 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 regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
