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HTMLFDA-Regulated Industry Litigation Update regarding "Made in the U.S.A." Claims
Melvin S. Drozen, Alissa D. Jijon, Richard F. Mann, Evangelia C. Pelonis, Frederick A. Stearns; Keller and Heckman LLP;
Legal Alert/Article
April 15, 2015, previously published on April 14, 2015
We look forward to having you join us for our upcoming webinar, “Made in the U.S.A.” Claims: A Marketer's Guide. Relatedly, we are writing with an update on a recent litigation development in the “Made in the U.S.A.” claim arena, particularly as it may have implications for...

 

HTMLEven Further Down the Rabbit Hole: New EU Legislation Adds to GMO Quagmire
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
April 9, 2015, previously published on January 29, 2015
A vote by European Union (EU) lawmakers in mid-January gave individual governments within the 28-nation bloc the authority to decide whether genetically modified organisms (GMOs) can be grown and cultivated within their borders. The move will give individual member states the ability to prohibit or...

 

HTMLDrug Quality and Security Act Does Not Apply to Veterinary Compounding
Patrick C. Gallagher, Rachael G. Pontikes, Alison T. Rosenblum; Duane Morris LLP;
Legal Alert/Article
March 30, 2015, previously published on March 6, 2015
While the Drug Quality and Security Act (DQSA) provided a new regulatory framework for compounded medications for use in human medicine, it does not apply to veterinary compounded medications. There has been some confusion in the industry, but veterinary compounded medications are still regulated...

 

HTMLFDA Advises Pharma Companies to Simplify Consumer Print Ads, Hopes New Approach Will Resonate Better With Patients
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
March 18, 2015, previously published on February 2015
The FDA is recommending that drug companies aim for comprehension with their consumer-directed print ads by limiting the risk information, more fully integrating it via text and visual cues, and by using more consumer-friendly language.

 

HTMLFY 2016 Budget Request Reflects FDA’s Broadening Scope of Activities
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
March 18, 2015, previously published on February 2015
The regulator’s requested budget of $4.9 billion for the upcoming fiscal year represents a 9% increase from the enacted FY 2015 budget, with $147.7 million allocated for initiatives associated with what it calls “key areas,” including improving the safety and quality of medical...

 

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...

 

HTMLDraft Documents On Drug Compounding And Repackaging Issued By the FDA Help Entities Comply With Public Health Provisions
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
March 18, 2015, previously published on February 2015
The regulator published five draft documents as part of a larger series of policy documents concerning the FDA’s oversight of drugs produced by state-licensed pharmacies, federal facilities and outsourcing facilities.

 

HTMLCalifornia Appellate Court Finds No Malicious Product Tampering Coverage for Westland’s Ground Beef
Joseph F. Bermudez, Suzanne M. Meintzer; Wilson Elser Moskowitz Edelman & Dicker LLP;
Legal Alert/Article
March 5, 2015, previously published on February 11, 2015
In 2008, Windsor Food Quality Company, Ltd. (Windsor) purchased Westland/Hallmark Meat Company’s (Westland’s) ground beef as an ingredient to be used in its José Olé® frozen food products. On January 30, 2008, the U.S. Department of Agriculture (USDA) suspended...

 

HTMLXarelto Blood Thinner Lawsuits Consolidated in Louisiana Federal Court - Patients Allege Xarelto Linked to Serious Bleeding Risk
Wendy R. Fleishman; Lieff, Cabraser, Heimann & Bernstein, LLP;
Legal Alert/Article
March 3, 2015, previously published on December 19, 2014
Wendy R. Fleishman of the national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein, LLP, announced today that nearly two dozen lawsuits filed against Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer Corp. over the blood thinner Xarelto have been consolidated in...

 

HTMLFDA Issues Additional Guidances on Implementation of Drug Supply Chain Security Act
Duane Morris LLP;
Legal Alert/Article
March 3, 2015, previously published on February 25, 2015
The U.S. Food and Drug Administration (FDA) continues to publish draft guidance implementing the Drug Supply Chain Security Act (DSCSA). This Alert highlights key facts on three recent draft Guidance for Industry, which focus on: interoperable exchange of information, annual reporting by wholesale...

 


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