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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...

 

HTMLHow You Say It Makes a Difference - California False Advertising Claims Attacking "No Trans Fat" Labeling Gain Traction as Ninth Circuit Rejects Preemption Arguments
Robert S. Niemann; Keller and Heckman LLP;
Legal Alert/Article
April 27, 2015, previously published on March 24, 2015
The United States Court of Appeals for the Ninth Circuit held, in relevant part, that a consumer states a valid claim for false advertising when a company claims "No Trans Fats" for a product which has less than 0.5 grams of trans fats per serving (but more than 0 grams) even though Food...

 

HTMLFDA Issues Guidance on Meetings between Agency and Sponsors to Promote Consistency and Effectiveness
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
The agency is making recommendations on formal meetings about the development and review of drugs or biological products that fall under the regulation of the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in a bid to provide consistent...

 

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...

 

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.

 

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...

 


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