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FDA's 510(k) process currently under review — time for an “extreme makeover”?

USA - August 2 2010 The FDA is in the midst of a multi-year review of its 510(k) process, and this review will likely have a significant impact on the medical device industry.

David L. Rosen

The FDA warns 17 companies about nutritional claims on food labels and releases U.S. health and diet survey

USA - March 9 2010 March 3, 2010, the FDA announced that it had issued warning letters to 17 food manufacturers, stating that the companies have violated the Food, Drug, and Cosmetic Act (FDCA) by making misleading or unsubstantiated claims on food labels for 22 different products.

Nathan A. Beaver, Michael D. (Mike) Flanagan, David L. Rosen