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Adobe PDFConducting Clinical Trials in the US and Abroad: Navigating the Rising Tide of Regulation and Risk
Maureen Bennett, John B.T. Murray; Squire, Sanders & Dempsey L.L.P.;
November 5, 2009, previously published on October 2009
This section overviews the legal framework for conducting clinical trials in the US and abroad for clinical trials involving Food and Drug Administration (FDA)-regulated trials and those that are launched by US entities such as academic medical centers (AMC) that are not subject to FDA regulation....

 

HTMLNanosilver, Nanomaterials EHS Research in the Regulatory Spotlight Again
Martha E. Marrapese, Michael T. Novak; Keller and Heckman LLP;
October 30, 2009, previously published on October 22, 2009
Nanotechnology will take center stage before the Environmental Protection Agency (EPA) in the coming weeks. In early November, a Scientific Advisory Panel (SAP) will meet to evaluate nanosilver and other nanometal pesticides. Later that month, EPA will hold a meeting on the latest nanotech research...

 

HTMLNew Fire Safe Cigarette Certification - Deadlines in 2010
Paige S. Fitzgerald, Nancyellen Keane; Troutman Sanders LLP;
October 28, 2009, previously published on October 23, 2009
In 2003, New York passed legislation designed to enhance safety by requiring cigarettes sold in New York after June 2004 to be manufactured with papers that would make the cigarettes self-extinguishing. This initial piece of legislation on the subject of fire safe cigarettes, New York's fire safe...

 

Adobe PDFEPA Publishes New Research Strategy for Investigation of Nanomaterial Health & Environmental Risks
Orlyn (Skip) Lockard; Alston & Bird LLP;
October 16, 2009, previously published on October 5, 2009
The U.S. Environmental Protection Agency (EPA) released the final version of its new "Nanomaterial Research Strategy" (or "report") on Tuesday, September 29, 2009. The report, previously released in draft form in June 2009, details EPA's overall strategy for investigating the...

 

Adobe PDFFTC Tightens Rules for Endorsement Advertising -- Effective December 1, 2009
Andrew G. Berg, Ed Chansky, Tracie R. Chesterman, Irving Scher, Alan N. Sutin; Greenberg Traurig, LLP;
October 14, 2009, previously published on October 2009
The Federal Trade Commission (FTC) recently announced revisions to its "Guides Concerning The Use of Endorsements and Testimonials." The new Guides cover more situations than before and impose stricter standards in many situations. They take effect December 1, 2009. Below are key...

 

HTMLEuropean Commission Endorses Belgian Regulator's Proposal to Restore Regulation in Wholesale Broadband Markets
Karel Janssens; Crowell & Moring;
October 2, 2009, previously published on September 30, 2009
By letter of 21 August 2009, the European Commission has endorsed the proposal of the Belgian regulator IBPT to retroactively restore regulation in the markets for wholesale access to telecoms infrastructure and broadband services.

 

HTMLFCC Seeks Comment on Smart Grid Technologies
Melissa Glidden Tye, Brett H. Freedson, George M. Foote; Bracewell & Giuliani LLP;
September 30, 2009, previously published on September 16, 2009
The American Recovery and Reinvestment Act of 2009 directed the Federal Communications Commission to develop a National Broadband Plan. To help develop that plan, the FCC has requested comment on how advanced telecommunications services and infrastructure, and broadband in particular, can help...

 

Adobe PDFDouble Standards at the Federal Circuit
Jeffrey A. Wolfson, Evert Farah To Uy; Haynes and Boone, LLP;
September 23, 2009, previously published on September 21, 2009
Generally, "product" claims in a patent define a product in terms of its structure, properties, or composition. A product claim could thus cover a pharmaceutical composition or formulation with a well-characterized compound and useful excipients, a light-weight alloy used in windmill...

 

HTMLEarn Outs in Medical Technology Acquisitions: Don't Stop at the Milestones
Gordon S. Weber; Faegre & Benson LLP;
September 16, 2009, previously published on September 15, 2009
Earn outs, or milestone payments, often are critical elements in medical technology acquisitions. Outside of the medical technology field, an earn out may be the last resort for saving a transaction when the buyer and seller cannot otherwise agree on valuation. However, in a medical technology...

 

Adobe PDFTSCA Interagency Testing Committee Report Signals Continued Emphasis on Agency Requests for and Review of Data on Nanoscale Materials
Lawrence E. Culleen, Fern Phillips O'Brian, Matthew T. Heartney, Karen J. Nardi; Arnold & Porter LLP;
September 10, 2009, previously published on September 2009
The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) has submitted its 64th report to the US Environmental Protection Agency (EPA or Agency), and the Report demonstrates the Agency's intention to require the submission of new and existing data on the potential health and...

 


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