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HTMLFDA Finalizes Three Guidance Documents on Biosimilars
Edgar J. Asebey, Maureen Bennett, Christian B. Fulda, Colleen Heisey, Christopher M. Mikson; Jones Day;
Legal Alert/Article
May 15, 2015, previously published on May 2015
FDA recently finalized three draft guidance documents addressing scientific and regulatory issues associated with the development and licensure of biosimilars.


HTMLOPDP to Study The Impact of Comparative Pricing Information in DTC and Professional Prescription Ads
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The agency will investigate how prescription drug product perceptions are impacted by the inclusion of price comparison information and supplementary contextual information in advertising geared at consumers and health care professionals, amid concern that the impression remains that price is the...


HTMLCan You Label your Food Product as "Healthy?"
John W. Mashni; Foster, Swift, Collins & Smith, P.C.;
Legal Alert/Article
May 15, 2015, previously published on April 30, 2015
Do you sell a food product that you would like to label as “healthy?” Using the term is more complicated than it seems. One company has recently discovered how seriously the government regulates food labeling.


HTMLGuidance Explains How The FDA Will Define and Process Submissions for Changes to Risk Management Plans
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The regulator issued guidance on changes to approved risk evaluation and mitigation strategies (REMS), distinguishing “modifications” from “revisions,” and explaining how these should be submitted and how the FDA will review and act on them.


HTMLFDA to Conduct Study to Determine Whether Medical Device Labeling Should Be Standardized
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 14, 2015, previously published on April 2015
The study will look into whether a standard format of labeling would be beneficial to healthcare providers, as the regulator worries current labeling is too complicated and difficult to navigate.


HTMLChina Passes Sweeping Amendment to Food Safety Law: The Most Stringent To Date
Yun Chen, David J. Ettinger, Mark Thompson; Keller and Heckman LLP;
Legal Alert/Article
May 13, 2015
On April 25, 2015, after two rounds of comment solicitation and revision in 2013 and 2014, the Standing Committee of the National People's Congress of China passed the amended Food Safety Law (“Law”).[1] The Law, which will enter into force on October 1, 2015, is considered the most...


HTMLNanotechnology in Food: A Recipe for Controversy
David M. Governo, Sarah E. O'Leary; Governo Law Firm LLC;
Legal Alert/Article
May 13, 2015, previously published on April 28, 2015
Dunkin' Donuts recently made headlines when the company agreed to remove the nanoparticle titanium dioxide from the powdered sugar in its popular donuts. Titanium dioxide is used in powdered donuts as a whitening agent, increasing the attractiveness of Dunkin's products. Other nanoparticles such as...


HTMLWindsor Food Quality Co. v. Underwriters of Lloyd's of London (4th Dist.Ct.App. 2015), --- Cal.App.4th ----, 2015 DJDAR 2507, Case No. E058324
McCormick Barstow Sheppard Wayte Carruth LLP;
Legal Alert/Article
May 7, 2015
Windsor manufactured frozen food products using ground beef supplied by Westland. The USDA announced a voluntary class II recall of Westland products because Westland had used beef from non-ambulatory disabled cattle, which beef may have been contaminated with mad cow disease. Windsor recalled its...


HTMLUnited States Court of Appeals For The Fourth Circuit Denies Petition For Rehearing In Historic Appeal Against Chelsea Therapeutics
Faruqi Faruqi LLP;
Legal Alert/Article
May 7, 2015, previously published on April 13, 2015
On March 16, 2015, the United States Court of Appeals for the Fourth Circuit determined that the claims asserted against Chelsea Therapeutics International, Ltd. should be remanded for further proceedings because the claims had been erroneously dismissed by the district court:


HTMLNew Law Puts California Operators in Labor Bind
Jeffrey S. Horton Thomas; Thomas Employment Law Advocates;
Legal Alert/Article
May 1, 2015, previously published by Restaurant Hospitality on January 2015
Effective January 1, 2015, restaurants, bars, hotels and other businesses that bring in workers through other companies - such as outside valet parking, security, landscape maintenance and temp companies - will be liable to the workers whenever their actual employer (the valet parking company, for...


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