Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Utah Medical case closed: Utah Medical Products says it was informed Dec. 15 by the Department of Justice that the government will not appeal an Oct. 21 Utah U.S. District Court decision favoring the firm in a case brought by FDA. The agency had tried to impose a permanent sales injunction on Utah Medical based on charges of recurring quality system lapses. The deadline for an appeal was Dec. 20. FDA has signaled that the ruling will not deter it from pursuing future suits against firms it deems to have deficient manufacturing practices (1"The Gray Sheet" Dec. 12, 2005, p. 12)...