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|FDA Issues Final GRAS Rule; Formally Adopts Voluntary Notification Process|
Joan Sylvain Baughan, Azim Chowdhury, Mitzi Ng Clark, David J. Ettinger, Jeffrey A. Keithline; Keller and Heckman LLP;
August 25, 2016, previously published on August 17, 2016The U.S. Food and Drug Administration (FDA) published a final rule In the Federal Register on August 17, 2016, that seeks to clarify the process and criteria used to determine whether the use of a substance in human or animal food is generally recognized as safe (GRAS). The rule applies to...
|FDA Releases Revised Guidance on Device Modification Policy|
Benjamin Zegarelli; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
August 24, 2016, previously published on August 16, 2016FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft guidance, entitled Deciding When to Submit a 510(k) for a Change to an...
|Second Circuit: Aluminum End Users Lack Antitrust Standing; Price Manipulation Claims Against Traders and Warehouses Foiled|
Matthew AR Cohen, Robert G. Kidwell, Bruce D. Sokler, Lydia E. Turnier; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
August 23, 2016, previously published on August 15, 2016Last week, in In re Aluminum Warehousing Antitrust Litigation, the US Court of Appeals for the Second Circuit (“Second Circuit”) rejected a claim by certain downstream end-users of aluminum that their price manipulation antitrust suit should be allowed to proceed. The Second Circuit...
|Australia Seeks Tougher Penalties and Makes Increased Use of Commitments in Settlements|
Prudence Smith, Nick Taylor; Jones Day;
August 18, 2016, previously published on August 2016We have in recent alerts discussed the increasingly aggressive enforcement activities of the Australian Competition and Consumer Commission. Unremittingly higher penalties is one unfortunate characteristic of the ACCC's enforcement program, mitigated somewhat by its willingness to accept...
|Off-Label Use: Protected Commercial Speech or Misbranding?|
David W. Ohlwein; Butler Snow LLP;
August 17, 2016, previously published on Spring 2016For years, the Food and Drug Administration has recognized that there is a prevalence of off-label use of drugs approved by FDA for specific indications, there is clinical relevance and value from such off-label use, and there is a large amount of information about both on- and off-label uses of...
|FDA Releases Draft Guidances on What Constitute "Essentially Copies" of Commercially Available or Approved Drug Products|
Duane Morris LLP;
August 17, 2016, previously published on August 4, 2016When Congress enacted the Drug Quality and Security Act in 2013, it provided that state-licensed pharmacies engaging in drug compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) could not “compound regularly or in inordinate amounts (as defined by the Secretary)...
|Helpful Amendments to the New Trade Reporting Rules Finalized|
Mark S. Powell; Bennett Jones LLP;
August 17, 2016, previously published on July 4, 2016On June 30, 2016, the securities regulators of Alberta, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Prince Edward Island, Saskatchewan and Yukon (the "Announcing Jurisdictions") announced that they had finalized certain amendments to the...
|Federal Court of Appeal: Government Failed to Adequately Consult with First Nations on Northern Gateway|
David W. Bursey, Radha D. Curpen, Francco De Luca, Brad Gilmour, Jessica E. Mathewson; Bennett Jones LLP;
August 17, 2016, previously published on July 24, 2016On June 23, 2016, the Federal Court of Appeal delivered the Northern Gateway Project another procedural setback in its decision on Gitxaala Nation v Canada (2016 FCA 187). In a 2-to-1 split decision, the court overturned the federal Cabinet's June 2014 approval of Enbridge’s Northern Gateway...
|China MOFCOM Uses New Market Definition in AB InBev's Acquisition of SABMiller|
Lawrence Wang, Peter J. Wang, Yizhe Zhang; Jones Day;
August 17, 2016, previously published on August 2016The Chinese Ministry of Commerce (MOFCOM), China’s antitrust enforcement agency for mergers, has conditionally approved the USD108 billion acquisition of SABMiller PLC by Anheuser-Busch InBev NV, in a Decision published July 29, 2016. The MOFCOM Decision requires divestiture of the 49%...
|Brexit: Implications for UK Competition Law|
Simon Harms, Lisa Navarro, Gillian Sproul; Greenberg Traurig Maher LLP;
August 16, 2016, previously published on August 4, 2016This note addresses the impact of Brexit on UK competition law - its interpretation, application, and enforcement. It is one of a series of GTM Alerts designed to assist businesses in identifying the legal issues to consider and address in response to the UK's referendum vote of 23 June 2016 to...