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HTMLAmarin and FDA Agree to Landmark Settlement on Off-Label Promotion
Michael A. Carvin, Toni-Ann Citera, Colleen Heisey, Karen P. Hewitt, Laura F. Laemmle-Weidenfeld; Jones Day;
Legal Alert/Article
April 6, 2016, previously published on March 2016
On March 8, 2016, Amarin Pharma, Inc. reached a noteworthy settlement in its lawsuit against the U.S. Food and Drug Administration ("FDA") to protect its First Amendment right to promote the drug Vascepa for nonapproved, off-label uses. Amarin Pharma, Inc. v. FDA (S.D.N.Y. No. 15-cv-3588)...

 

HTMLBipartisan Bill Aims to Increase Hires at FDA and NIH
McDonald Hopkins LLC;
Legal Alert/Article
March 24, 2016, previously published on March 18, 2016
On Thursday, Senators Lamar Alexander (R-TN) and Patty Murray (D-WA), the chair and ranking member respectively, of the Senate Health, Education, Labor and Pensions Committee, introduced a bill intended to make it easier for the Food and Drug Administration (FDA) and the National Institutes of...

 

HTMLTrial Court Upholds NYC Regulation Mandating Chain Restaurant Menu Labeling for Excess Salt Content
Anna M. Wiand; GrayRobinson, P.A.;
Legal Alert/Article
March 23, 2016, previously published on February 25, 2016
On February 24, 2016, a New York state trial judge ruled that chain restaurants in New York City must warn customers about menu items containing high levels of sodium. At issue is a municipal regulation adopted by the New York City Board of Health in September of 2015 that applies to chain...

 

HTMLAnother California Dismissal of Proposed Class Action Regarding Disclosure of Forced Labor in the Supply Chain
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
March 22, 2016, previously published on March 7, 2016
We recently blogged about a new wave of class action litigation related to California’s Transparency in Supply Chains Act. In December, Nestlé USA won the dismissal of a complaint against it alleging that the company was “obligated to inform consumers that some proportion of its...

 

HTMLAmarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
March 21, 2016, previously published on March 11, 2016
On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to treat Amarin’s proposed truthful and non-misleading off-label...

 

HTMLSouth Florida Alcohol and Liquor Licensing - A Snapshot
Valerie Lewis Haber; GrayRobinson, P.A.;
Legal Alert/Article
March 15, 2016, previously published on March 3, 2016
Many clients come to GrayRobinson’s Alcohol Law Group with the misconception that getting a beer and wine license, or liquor license in South Florida, (including the City of Miami, Miami Beach, Fort Lauderdale, Broward County or Palm Beach County,) will be a straightforward process. Before...

 

HTMLAgencies Engaged in Federal Biotech Overhaul to Host Final Two Public Sessions in March
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
March 10, 2016, previously published on February 28, 2016
After hosting the first of three stakeholder meetings late last year, federal government agencies engaged in overhauling the 1986 Coordinated Framework for the Regulation of Biotechnology recently announced that meetings two and three will take place on March 9 and March 30 in Dallas, Texas and...

 

HTMLFDA Extends Public Comment Period on Proposal to Define "Natural" for Food Labeling Purposes
Richard M. Blau; GrayRobinson, P.A.;
Legal Alert/Article
March 2, 2016, previously published on February 19, 2016
The FDA has extended the deadline for receiving public comments regarding the need for promulgation of regulations relating to the food and beverage industries’ use of the term “natural” on food labeling. The public comment period will end on May 10, 2016, rather than the end of...

 

HTMLFDA Extends Public Comment Period for New Regulation on Labeling "Gluten-Free" Foods and Beverages
Anna M. Wiand; GrayRobinson, P.A.;
Legal Alert/Article
March 2, 2016, previously published on February 22, 2016
The US Food and Drug Administration (FDA) recently announced that it has extend the period for public comments on a proposed rule to establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear a “gluten-free” claim. FDA...

 

HTMLPreemption Defense in the Ninth Circuit Is “Not Dead Yet”
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
February 25, 2016, previously published on February 19, 2016
Monty Python and the Holy Grail (1975) contained a scene where bodies of plague victims were brought out to the curb for collection via a cart whether or not they properly belonged there. One living fellow insists on not being dead by exclaiming: “I’m not dead yet.” Unfortunately...

 


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