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Health Law and RegulationSTORY OF THE WEEK Share this article with a colleague!
U.S. Worry Over Safety of Imported Products Prompts Meetings with ChinaAgriculture Secretary Mike Johanns, Secretary of Health and Human Services (HHS) Mike Leavitt and other representatives of the U.S. government are meeting with representatives of the government of the People’s Republic of China to request rapid action related to the safety of food and drugs. U.S. officials are emphasizing the need for three things: to have better cooperation, to have better information, and to have the Chinese devise and enforce regulations agreed upon and understood by the U.S. In coming months, both countries will participate in a series of bilateral meetings on food and drug safety. Two Memoranda of Agreements (MOA) will be developed between the governments — one on the safety of food and feed and another on the safety of drugs and medical devices. The meetings and the MOAs to be developed are important steps forward in addressing problems with food and other imports from China, which investigations by the Food and Drug Administration have brought to light. U.S. regulatory agencies are concerned about what they see as an insufficient infrastructure across the board in China to assure the safety, quality and effectiveness of many products exported to the United States. HHS hopes to achieve two, strong, action-oriented documents by December by combining technology, scientific expertise and commitment from each country. Source: United States Department of Health and Human Services, July 30, 2007 Understanding FDA Drug and Biologic Adverse Event Regulations, 2006 EditionThis new book from FDAnews will go straight to your ready-reference shelf. It’s the best source for helping you and your staff make sense of often confusing reporting directives and protocols — and you’ll gain a greater sense of control over the adverse events reporting process. Understanding FDA Drug and Biologic Adverse Event Regulations, 2006 Edition is available from the Healthcare Intelligence Network for $305 by visiting our Online Bookstore or by calling toll-free (888) 446-3530. Share this article with a colleague!IMPORTANT NOTICE: This information is designed to provide accurate and authoritative information on the business of healthcare. It is distributed with the understanding that Healthcare Intelligence Network is not engaged in rendering legal advice. If legal advice is required, the services of a competent professional should be retained. | |
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