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HTMLFDA Issues Draft Guidance Regarding Controlled Correspondence from Generics Manufacturers
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
September 18, 2014, previously published on September 9, 2014
On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify issues related to generic drug development, and the FDA’s procedure for...

 

HTMLFTC Doubles Down in Challenge to Pharmaceutical Settlement
Paul M. Eckles, Karen Hoffman Lent, Sharis A. Pozen, Steven C. Sunshine; Skadden, Arps, Slate, Meagher & Flom LLP;
Legal Alert/Article
September 15, 2014, previously published on September 10, 2014
On September 8, 2014, the Federal Trade Commission (FTC) filed a federal antitrust complaint in the United States District Court for the Eastern District of Pennsylvania against defendants AbbVie, Abbott Laboratories, Unimed Pharmaceuticals, Besins Healthcare and Teva Pharmaceuticals alleging...

 

HTMLLiver Injury Cases Increased Along With Dietary and Herbal Supplement Sales
Seth A. Katz; Burg Simpson Eldredge Hersh & Jardine, P.C.;
Legal Alert/Article
September 11, 2014, previously published on September 5, 2014
A new study from researchers in Philadelphia revealed liver damage from dietary and herbal supplements might have increased over the last 10 years. The report "Liver injury from Herbals and Dietary Supplements in the U.S. Drug Induced Liver Injury Network" showed 4 percent of adult...

 

HTMLBrand-Name Drug Manufacturer Liable For Personal Injuries Caused By Generic Drugs Manufactured By Different Company In Alabama
Sutherland Asbill Brennan LLP;
Legal Alert/Article
September 4, 2014, previously published on August 25, 2014
The Supreme Court of Alabama held last week that under Alabama law, a brand-name drug company can be held liable for fraud or misrepresentation based on statements made in connection with the manufacture of a brand-name prescription drug by a plaintiff claiming physical injury cause by a generic...

 

HTMLConsidering Sex-Specific Variation for Personalized Medicine
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
September 4, 2014, previously published on September 2, 2014
Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a particular cancer therapy. In some instances, the prediction of clinical...

 

HTMLFDA Proposes a New Layer of Regulation for Laboratory Developed Tests
Caroline M. Tinsley; Baker Sterchi Cowden & Rice, L.L.C.;
Legal Alert/Article
September 2, 2014, previously published on August 21, 2014
The Food and Drug Administration (FDA) announced its intention to expand the regulation of laboratory developed tests (LDTs). LDTs identify patients’ individual reactions to pharmaceutical treatments, so medical providers can prescribe the best treatment for the particular patient. Unlike...

 

HTMLGeneric Drug Labeling: Brand-Name Drug Manufacturers Can Be Held Liable for Warnings on Generic Versions
Fred Thompson; Motley Rice;
Legal Alert/Article
September 2, 2014, previously published on August 29, 2014
The controversial Wyeth v. Weeks decision, which was confirmed by the Alabama Supreme Court this past August 15, 2014, provided a welcome ray of hope in a preemption landscape made desolate by the Mensing decision of 2011.

 

HTMLSecond Circuit Clarifies the Use of Legal Presumptions of Consumer Confusion and Injury in Certain Lanham Act Cases
Bruce A. Colbath; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
August 27, 2014, previously published on August 21, 2014
On Tuesday, July 29, the United States Court of Appeals for the Second Circuit “clarified certain aspects of [its] false advertising jurisprudence” and held that, where literal falsity and deliberate deception have been proved in a market with only two players, it is appropriate to use...

 

HTMLSham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential For New Liability For Innovators?
Robert L. Magielnicki; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
August 19, 2014, previously published on August 12, 2014
Under what is commonly known as “Noerr-Pennington immunity,” persons exercising their First Amendment right to petition the government for redress are generally immune from antitrust liability, even though their actions may harm competition or competitors. The Supreme Court has...

 

HTMLFDA Declines to Issue Rulemaking for Section 505(b)(2) NDA Therapeutic Equivalence Ratings
Duane Morris LLP;
Legal Alert/Article
August 18, 2014, previously published on August 11, 2014
On July 23, 2014, the Food and Drug Administration (FDA) issued its response to two citizen petitions submitted by AbbVie Inc. (AbbVie) and Auxilium Pharmaceuticals, Inc. (Auxilium) requesting that FDA initiate notice-and-comment rulemaking under the Administrative Procedure Act (APA) to establish...

 


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