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HTMLCompetition Bureau Releases Updated IP Guidelines
Jonathan Bitran, Dominic Thérien; McCarthy Tétrault LLP;
Legal Alert/Article
October 28, 2014, previously published on October 20, 2014
On September 18, 2014, the Competition Bureau (Bureau) released updated Intellectual Property Enforcement Guidelines (IPEGs). These IPEGs are an update of the original guidelines released in 2000 and result from recent consultations; the Bureau has announced that it will soon conduct another...


HTMLFDA Fast-Tracking Experimental Drugs
McDonald Hopkins LLC;
Legal Alert/Article
October 22, 2014, previously published on October 17, 2014
The development of a pharmaceutical drug is a slow, deliberate process, and it can take years of back-and-forth between scientists and health officials before medicine makes it to the market.


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...


HTMLTime to Step Up Your COPPA Compliance
Cynthia J. Larose, Julia M. Siripurapu; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
October 3, 2014, previously published on September 25, 2014
The Federal Trade Commission (FTC) has made good on its promise to actively enforce the recently amended Children’s Online Privacy Protection Act (COPPA). Here is what you should know about the latest enforcement actions against Yelp and TinyCo and how these might affect your business.


HTMLFDA Issues Draft Guidance Regarding Controlled Correspondence from Generics Manufacturers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On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify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


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