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…National Transportation Safety Board Conference Center in Washington, D.C. Registration is required and must be submitted by October 9, 2009. Participation will be determined on a first-come, first-served basis. To…
The National Institutes of Health (“NIH”) recently launched a database of labels of dietary supplements being sold in the United States. The database includes, among other information, directions for use,…
…legal blog writing online today. Now that the blogs have been nominated and placed into their respective categories, it is up to their readers to select the very best. With…
…BCP’s last non-Acting Director, the Bureau had a pronounced focus on health benefit advertising – with high-profile cases involving products such as muscle-toning tennis shoes and breakfast cereals marketed with…
…allegedly deceptive weight loss claims. FTC’s enforcement actions against products allegedly marketed with bogus weight loss claims As part of its initiative, the FTC announced enforcement actions against four different…
By Ricardo Carvajal – The Institute of Medicine (“IOM”) published a summary report of the workshop on caffeine in food and dietary supplements that IOM convened last August at FDA’s…
…was not so lucky in its latest match against Massachusetts Governor Deval Patrick. Last week, the U.S. District Court for the District of Massachusetts issued a decision allowing in part…
…would not apply to non restricted medical devices (i.e., almost all Class I and Class II devices). It may be that FDA would disagree with this analysis. Rather than allowing…
…level, and found incorrect identification of fish species 15% of the time. Almost all mislabeling occurred in the snapper and grouper categories. It remains to be seen whether the educational…
By Karla L. Palmer – Last week, several congressional representatives announced the introduction of H.R. 3537, the “Synthetic Drug Control Act of 2015.” If enacted, the Synthetic Drug Control Act would…
…as MEDLINE and PubMed) and online scientific and medical publishers (such as the Public Library of Science (PLoS) and the Cochrane Library).” The draft guidance also clearly states that because…
…ramifications for activities in which many stakeholders hold strong interests-healthcare professionals including prescribers and pharmacists, regulators and especially patients. How will the American Medical Association and state medical boards react…
…FDA issued its proposed rule in 2014 (see our previous post here). FDA received about 240 comments and the final rule is almost 80 pages long. A fact sheet of…
…test components, set technical specifications for each step of an NGS-based test, and document the limitations of each component for critical factors. The draft guidance identifies several specific test design…
…fact, after the ALJ has issued a recommended opinion and the agency has published its final decision, known as a final order, in the Federal Register. According to a 2014…