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Documents on Antitrust & Trade Regulation, Food & Beverage
 

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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FDA recently finalized three draft guidance documents addressing scientific and regulatory issues associated with the development and licensure of biosimilars.

 

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.

 

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...

 

HTMLFDA Issues Guidance Documents on How It Considers Balancing Premarket and Postmarket Data Collection During PMA Reviews in a Bid to Accelerate the Approval of New Breakthrough Devices
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The regulator explains how it determines when it’s appropriate to increase reliance on postmarket collection to reduce the extent of premarket collection to support premarket approval, in a document integral to the CDRH’s risk-based approach to regulation and the FDA’s broader...

 

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...

 

HTMLAscertainability Saps Plaintiffs’ Energy in Dietary Supplement Class Action
Paul Seeley; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
March 18, 2015, previously published on March 4, 2015
In the recent decision Mirabella v. Vital Pharmaceuticals, Inc., Case No. 12-62086-CIV-ZLOCH (S.D. Fl. Feb. 27, 2015) the plaintiffs attempted, but failed, to certify a nationwide class of all purchasers of an energy drink that allegedly caused harmful side-effects. The plaintiffs brought claims...

 

HTMLDole Defeats “All Natural Claims” for Sweet Victory
Robin A. Achen; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 25, 2015, previously published on December 10, 2014
On December 8, 2014, U.S. District Court Judge Lucy Koh of the U.S. District Court for the Northern District of California granted defendant Dole’s motion for summary judgment of the plaintiff’s false labeling claims in Brazil v. Dole Packaged Foods, LLC. The court granted summary...

 

HTMLFaulty Damages Model Leads to Partial Decertification
Robin A. Achen; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 25, 2015, previously published on November 21, 2014
On November 6, 2014, U.S. District Court Judge Lucy Koh of the U.S. District Court for the Northern District of California granted in part defendant Dole’s motion for decertification in Brazil v. Dole Packaged Foods, LLC. In May of 2014, the court had granted certification of classes under...

 

HTMLSummary of Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., 2014-1391
Yoonhee Kim; Sughrue Mion PLLC;
Legal Alert/Article
February 17, 2015, previously published on December 3, 2014
On December 3, 2014, in Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) vacated the district court’s judgment of invalidity, holding that the district erred in determining inherency in the context of...

 


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