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…call for the media, FDA stressed that the manufacture and marketing of these products is illegal and constitutes a criminal activity. According to FDA, the “spiked” products pose a serious…
…again directs FDA to establish a standard symbol system for front-of-package labeling for conventional foods. A food would be misbranded unless its principal display panel bears “summary nutrition information that…
…to online summaries of two studies that pertain to prevention and treatment of macular degeneration: ‘Age-Related Eye Disease Study (AREDS), National Eye Institute, National Institutes of Health’ [and] ‘Age-Related Eye…
…industry, Godot finally made a cameo appearance as FDA issued a draft guidance titled, “Fulfilling Regulatory Requirements for Postmarketing Submission of Interactive Promotional Media for Prescription Human and Animal Drugs and…
…program antikickback statute (“AKS”, 42 USC 1320a-7b(b)), the OIG recognized that the program operates entirely outside of all Federal health care programs, meaning that patients obtain the product without using…
…number of calories in standard menu items by listing calories adjacent to the name and price of the menu item and under a heading “Calories” or “Cal.” As currently drafted,…
…and himself, Mr. Sasinowski offered four recommendations: Proposal #1: FDA should consider the appropriateness of the Accelerated Approval process for every new therapy. Proposal #2: FDA and sponsors should use intermediate clinical…
…premarket submission may require animal or clinical studies, additional performance specifications, and other additional information to support clearance or approval, even if it conforms to relevant consensus standards. The new…
By Cassandra A. Soltis – For the first time ever, the Federal Trade Commission (“FTC”) took action against a consumer for misrepresenting in a testimonial the amount of money she…
…consumers depends on whether the annual monetary value of sale of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. …
…falsely claimed that their cosmetic products are “all natural” or “100% natural,” even though their products contained synthetic ingredients. Allegedly the companies made the all and 100% natural claims in…
…drive further innovation in response to real world performance and user feedback. Unlike most traditional medical device products, Digital Health has the potential to offer real-time learning through real world…
…minors. Finally, FDA is also continuing its efforts on science-based campaigns to educate minors about the dangers of all tobacco products, including e-cigarettes. FDA Commissioner Gottlieb makes clear the focus…
…principal changes that are not fee-related. FDAGA 2008 proposed several new requirements and authorities applicable to foods, including establishment of a food safety plan, safety standards for fresh produce, periodic…
…the scientific review of medical devices.” The October 14, 2008 letter to Chairman Dingell is quite remarkable and includes several serious allegations. According to the letter: This misconduct reaches the…