Sen. Dick Durbin, D-Ill., introduced legislation July 12 to require FDA to collect user fees on imported food products to generate revenue for inspections of food and food safety research. According to the bill, foreign firms and governments exporting goods to the U.S. must pay user fees and apply for certification with FDA. Only entities with standards equivalent to those of the U.S. for food safety, inspection, labeling and consumer protection will be eligible for certification, the bill says. Additionally, U.S. regulators could pull certifications if entities fail to comply and could also detain products that fail to meet standards. "While the volume of imports has nearly doubled over the last three years, the number of FDA inspectors has been steadily decreasing," Durbin states in a press release. "The system needs to be fixed immediately." Although FDA would determine the dollar amount of the fee, the bill would limit it to a maximum of $20 per line item. Durbin and Rep. Rosa DeLauro, D-Conn., sent a letter to FDA June 28 urging it to develop a memorandum of understanding with China in light of recent problems with imports from the country (1"The Tan Sheet" July 9, 2007, p. 7)...
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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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