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American Intellectual Property Law Association (AIPLA) - Patent Registry Scams; Australian Patent Office - Warning!Unsolicited IP Services; Belgian Patent Office - Warning to inventors about fraudulent registration services, in (in Dutch) or (in French) (with link to a Decision of January 14, 2005 of a Belgian Appeal Court (Brussels, R.G. 2003/AR/2192 and 2003/AR/2356) (pdf) - in French)
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
An intellectual property (IP) infringement is the infringement or violation of an intellectual property right. There are several types of intellectual property rights, such as copyrights, patents, trademarks, industrial designs, plant breeders rights [1] and trade secrets. Therefore, an intellectual property infringement may for instance be one ...
Legal claims against the pharmaceutical industry have varied widely over the past two decades, including Medicare and Medicaid fraud, off-label promotion, and inadequate manufacturing practices. [ 3 ] [ 4 ] With respect to off-label promotion, specifically, a federal court recognized off-label promotion as a violation of the False Claims Act ...
To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.
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Intellectual property derives its value from a wide range of parameters such as usefulness, market share, barriers to entry, legal protection, profitability, industrial and economic factors, growth projections, remaining economic life, and new technologies, all of which will inhere in the valuation. The value of an IP asset essentially comes ...
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.