FDA Commissioner Andrew von Eschenbach and Deputy Commissioner for International and Special Programs Murray Lumpkin meet with China's minister of health and commissioner of China's State Food and Drug Administration as the two countries try to finalize a memorandum of agreement on the import safety of food, drugs and medical devices. While not providing details of the MOA, Lumpkin notes that FDA's "preference is obviously not to have to catch problems in the products at our borders ... but prevent them at the source of their manufacturer." Von Eschenbach suggests the MOA will be finalized and presented in early December, in time for HHS Secretary Leavitt's visit to China. The meeting in Shanghai is the latest effort spawning from the Bush administration's Interagency Working Group on Import Safety that was established in July...
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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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US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
