Searching Content indexed under Litigation, Mediation & Arbitration by Colleen Heisey ordered by Published Date Descending.
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FSIS Announces Civil And Criminal Actions Against Individuals Who Inhumanely Handle Livestock
The Agency intends to initiate civil or criminal action against these individuals.
United States
23 Nov 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.
United States
14 Apr 2016
California Supreme Court Says Organic Labeling Suit Is Not Preempted
On December 3, 2015, the California Supreme Court overturned an appellate court's ruling unanimously holding that a state law claim that produce is being intentionally mislabeled as "organic" is not preempted by federal law.
United States
22 Dec 2015
EPA Issues Final Cancellation Order For Pesticide Products Containing Sulfoxaflor
On November 12, 2015, the Environmental Protection Agency ("EPA") issued a final cancellation order prohibiting the sale and distribution of all pesticide products containing the active ingredient sulfoxaflor.
United States
7 Dec 2015
AMA Proposes Ban On Advertising Prescription Medical Products To Consumers
On November 17, 2015, physicians at the Interim Meeting of the American Medical Association ("AMA") adopted a new policy calling for a ban on DTC advertising of prescription drugs and medical devices.
United States
23 Nov 2015
Safe Harbor Ruling: MEPs Call For Clarity And Effective Protection
Safe Harbor Ruling: Meps Call For Clarity And Effective Protection
European Union
5 Nov 2015
Court Rules Drugmakers Not Required To Provide Orphan Drugs To Certain Covered Entities Under 340B Program
Last month, in the case of PhRMA v. U.S. Department of Health & Human Services ("HHS"), a federal district court held that pharmaceutical companies are not required to provide orphan drugs to certain covered entities...
United States
4 Nov 2015
EU Court Clarifies Notification Obligation Of SVHC In Articles
On September 10, 2015, the EU Court of Justice delivered a key decision on the concept of an "article" containing Substances of Very High Concern ("SVHC"), which are included in the Candidate List.
European Union
26 Oct 2015
EU Court Suspends EMA Decision To Grant Access To Drug Data
The EMA issued a decision granting Novartis access to the requested reports on the basis that such documents did not contain "commercial confidential information."
European Union
23 Sep 2015
FDA Publishes Notice Of Patent Infringement Complaint Filed Against A Biosimilar Applicant
In the August 24, 2015, Federal Register, FDA announced that an applicant for a proposed biosimilar product had notified FDA that a patent infringement action has been filed in connection with the applicant's BLA.
United States
15 Sep 2015
District Court Rules Against FDA In Off-Label Marketing Case
Last week, a federal judge in the Southern District of New York granted a preliminary injunction in favor of Amarin Pharma, Inc. ("Amarin") in its dispute against FDA asserting free speech rights to promote an approved drug for unapproved uses based on truthful and nonmisleading communications
United States
17 Aug 2015
ECJ Issues Judgment On Labeling And Presentation Of Foodstuffs
On June 4, 2015, the European Court of Justice ("ECJ") published a decision on the interpretation of Directive 2000/13/CEE on labeling, presentation, and advertising of foodstuffs.
European Union
18 Jun 2015
German Court Holds That Umbrella Trademarks Are Permissible For Some Pharmaceutical Products
Last month, the German Federal Administrative Court issued a decision holding that, under certain circumstances, umbrella trademarks may be used for a portfolio of pharmaceutical products...
27 May 2015
Federal Circuit Grants Preliminary Injunction Against Marketing Of First Licensed Biosimilar
The court may rule on the motion by May 11, 2015, the date until which the applicant has agreed to stay off the market, absent judicial intervention.
United States
11 May 2015
German Court Refers Question On Nutrition And Health Claims Made On Foods To The ECJ
A German court asked the European Court of Justice ("ECJ") whether Regulation (EC) No 1924/2006 of the European Parliament and of the Council of December 20, 2006.
European Union
11 May 2015
European Court Of Justice Issues Decision On Pricing Of Medicinal Products, Scope Of National Health Insurance Systems
According to the ECJ, the obligation to disclose this information will allow interested parties to verify whether pricing decisions discriminate between national medicinal products and those originating in other Member States.
European Union
28 Apr 2015
Court Denies Motion To Delay Launch Of First Approved Biosimilar
The first U.S. biosimilar product Zarxio overcame another legal challenge earlier this month when a federal court in California denied a motion to enjoin its commercial launch.
United States
27 Apr 2015
Court Rules Biosimilar Patent Procedures Optional, Allows Marketing Of First Biosimilar
A federal court in California has ruled that under the Biologics Price Competition and Innovation Act a biosimilar applicant is not required to provide its application to the reference product sponsor.
United States
30 Mar 2015
Federal Court Dismisses Case Challenging USDA's New Poultry Inspection System
On February 9, 2015, the U.S. District Court for the District of Columbia dismissed a lawsuit challenging USDA's New Poultry Inspection System.
United States
19 Feb 2015
European Court Of Justice Rules On Orphan Drug Market Exclusivity
On January 22, 2015, the General Court of the European Court of Justice held that an orphan medicinal product that has the same therapeutic indication as a previously authorized orphan...
European Union
17 Feb 2015
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