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|FDA Fast-Tracking Experimental Drugs|
McDonald Hopkins LLC;
October 22, 2014, previously published on October 17, 2014The 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.
|Voters to Decide Whether Recreational Marijuana Should Be Legal—— Therefore Taxable—In Three More States|
McDonald Hopkins LLC;
October 18, 2014, previously published on OCtober 9, 2014In less than a month, voters in Alaska, Oregon, and the District of Columbia will decide whether to legalize the retail sale of recreational marijuana. According to ProCon.org, voters in 23 states, including these three, have already approved of programs allowing for the sale of medical marijuana;...
|Consultation on New Public Sector Regulations|
Stephen Abram, Stephen C. Tupper; Greenberg Traurig Maher LLP;
October 15, 2014, previously published on October 3, 2014The new Public Sector Directive 2014/24 (the New Public Sector Directive) on public procurement entered into force on 17 April 2014. This replaces Directive 2004/18. The New Public Sector Directive is accompanied by two other new directives, those for utilities and concession contracts...
|Focus on Competition Law Compliance - Competition Bureau Releases Draft Updated Bulletin on Corporate Compliance Programs|
Oliver J. Borgers, Michele F. Siu; McCarthy Tétrault LLP;
October 14, 2014, previously published on October 8, 2014Now, more than ever, it is critical for Canadian businesses to deploy an effective competition law compliance program. In a speech last month, Commission of Competition John Pecman reiterated that the best way for a company to reduce its risk of contravening the Competition Act is to put in place a...
|At Long Last: Draft Hong Kong Competition Law Guidelines Published|
Hannah C. L. Ha, John M. Hickin; Mayer Brown JSM;
October 14, 2014, previously published on October 9, 2014The Hong Kong Competition Commission (the “Commission”) today published long-awaited draft implementation guidelines (the “Guidelines”) to the Competition Ordinance (Cap. 619) (the “CO”).
|Tenth Circuit Affirms Class Certification and Price Fixing Verdict Against Dow Chemical|
Robert G. Kidwell, Helen J. Kim, Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
October 10, 2014, previously published on October 6, 2014The Tenth Circuit recently affirmed both class certification and one of the largest verdicts issued in the U.S. this year, denying Dow Chemical Company’s (“Dow”) appeal in a price fixing case related to polyurethane products. In Re: Urethane Antitrust Litigation, No. 13-3215 (10th...
|FDA Announces More Changes to FSMA Implementation Rules|
Michelle Gillette, Dominique Windberg; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
October 10, 2014, previously published on October 6, 2014On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many reported incidents of food-borne illness during the 2000s.
|FDA Issues Draft Guidance for Regulation of LDTs|
Antoinette F. Konski; Foley & Lardner LLP;
October 10, 2014, previously published on October 6, 2014On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance is the next step in FDA’s implementation of...
|Operation Full Disclosure! FTC’s Frontal Assault on Ads|
Michelle Gillette, Daniel J. Herling; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
October 10, 2014, previously published on October 2, 2014In this blog we often discuss products being subjected to a lawsuit based on allegations that a label is false or misleading under California’s consumer protection laws. The Federal Trade Commission is similarly concerned with the prevention of false and misleading claims, but its focus is...
|A Rare Decertification Decision from the BCCA Stands: No Leave to Appeal Wakelam|
Jill Yates; McCarthy Tétrault LLP;
October 8, 2014, previously published on September 5, 2014The 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...