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HTMLA Rare Decertification Decision from the BCCA Stands: No Leave to Appeal Wakelam
Jill Yates; McCarthy Tétrault LLP;
Legal Alert/Article
October 8, 2014, previously published on September 5, 2014
The Supreme Court of Canada yesterday refused the plaintiff’s application for leave to appeal the British Columbia Court of Appeal’s decertification decision in Wakelam v. Wyeth et al. Wakelam is a claim against various manufacturers of children’s cough and cold medication for...

 

HTMLDEA Releases Final Rule on Disposal of Controlled Substances
Duane Morris LLP;
Legal Alert/Article
October 3, 2014, previously published on September 26, 2014
On September 9, 2014, the U.S. Drug Enforcement Administration (DEA) released notice of a final rule governing the disposal of controlled substances (the "Final Rule"). The Final Rule implements the Secure and Responsible Drug Disposal Act of 2010 (the "Disposal Act"), and...

 

HTMLRecent Product Recalls
Jonathan Berman, Colleen Heisey, Mark Mansour, Stephanie L. Resnik, Emily K. Strunk; Jones Day;
Legal Alert/Article
September 23, 2014, previously published on September 2014
Recent food recalls involved undeclared allergens, microbial and foreign material contaminations, and choking hazards.

 

HTMLFDA Deputy Commissioner: Agency Focusing on Coordinated Food Safety and Specialized Inspectors
Jonathan Berman, Colleen Heisey, Mark Mansour, Stephanie L. Resnik, Emily K. Strunk; Jones Day;
Legal Alert/Article
September 23, 2014, previously published on September 2014
FDA continues to pursue a modern approach to food safety, as the agency adds specialized inspectors and develops new policies under the Food Safety Modernization Act. Mike Taylor, FDA's deputy commissioner for food, addressed a group of produce industry leaders earlier this month at the United...

 

HTMLRecent Warning Letters
Jonathan Berman, Colleen Heisey, Mark Mansour, Stephanie L. Resnik, Emily K. Strunk; Jones Day;
Legal Alert/Article
September 23, 2014, previously published on September 2014
Since the last Update, FDA posted warning letters to two canning companies for various violations, including packaging food in insanitary conditions and failing to submit scheduled processes to FDA.

 

HTMLSupreme Court Of Canada Denies Leave To Appeal From Decision Clarifying Available Disgorgement Remedies In Competition And Consumer Protection Claims
Michelle T. Maniago, Alessandra V. Nosko; Borden Ladner Gervais LLP;
Legal Alert/Article
September 18, 2014, previously published on September 8, 2014
On Thursday, September 4, 2014, the Supreme Court of Canada dismissed the plaintiffs’ motion for leave to appeal in Wakelam v. Wyeth Consumer Healthcare/Wyeth Soin de Sante Inc. The leave application arose from a 2014 British Columbia Court of Appeal decision that clarified whether plaintiffs...

 

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...

 

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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