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HTMLFDA Issues Draft Guidance Regarding Controlled Correspondence from Generics Manufacturers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On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify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...

 

HTMLCBP Issues Guidance on Acceptable Methods of Submitting Post-Importation Claims
Brian S. Goldstein; Duane Morris LLP;
Legal Alert/Article
September 15, 2014, previously published on September 9, 2014
As a follow-up to a memorandum issued by U.S. Customs and Border Protection (CBP) to its field offices on August 11, 2014, CBP has published a guidance to the trade community concerning "acceptable methods" for submission of post-importation claims for preferential treatment under various...

 

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...

 

HTMLAntibiotic Clarithromycin Linked To Increased Risk of Cardiac Death
Seth A. Katz; Burg Simpson Eldredge Hersh & Jardine, P.C.;
Legal Alert/Article
September 10, 2014, previously published on August 26, 2014
Danish researchers from the Statens Serum Institut in Copenhagen found the antibiotic clarithromycin increased the risk of cardiac-related deaths.

 

HTMLStudy Shows Using Antibiotics Early In Life Could Affect Immunity in the Long Term
Seth A. Katz; Burg Simpson Eldredge Hersh & Jardine, P.C.;
Legal Alert/Article
September 10, 2014, previously published on August 28, 2014
New research from the University of British Columbia has revealed that taking antibiotics early in life may harm your immunity later on. Antibiotics fight bacteria in a patient, but they don't differentiate between the good and the bad kind. As such, antibiotic treatments can end up attacking good...

 

HTMLDEA Moves Hydrocodone Combination Drugs to Schedule II
Seth A. Katz; Burg Simpson Eldredge Hersh & Jardine, P.C.;
Legal Alert/Article
September 10, 2014, previously published on August 27, 2014
The U.S. Drug Enforcement Administration has reclassified hydrocodone combination medications from Schedule III to Schedule II, increasing the restrictions on the drugs. Hydrocodone alone is already a Schedule II drug, but now medications that use a mixture of hydrocodone and another medication,...

 

HTMLFederal Circuit Finds Apotex ANDAs Do Not Infringe Lysteda Patents
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
September 4, 2014, previously published on September 2, 2014
In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either Apotex’s or Watson’s Abbreviated New Drug Applications...

 

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...

 


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