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HTMLPublic Contracts and Bill 26: Recovery of Amounts Improperly Paid and Changes to the AMF Authorization Regime
Pierre-Jérôme Bouchard, Pascale De Meyer, Clemens Mayr, Emmanuelle Poupart, Dominic Thérien; McCarthy Tetrault LLP;
Legal Alert/Article
May 21, 2015, previously published on April 28, 2015
Bill 26, entitled An Act to ensure mainly the recovery of amounts improperly paid as a result of fraud or fraudulent tactics in connection with public contracts[1] (the “Act”) was passed on March 24, 2015 and some provisions came into force on April 1, 2015.

 

HTMLListing, Prospectus, Disclosure and Transparency Rules: Miscellaneous Changes
Richard Barham, Candice Chapman, Rebecca Gordon; Dentons Canada LLP;
Legal Alert/Article
May 19, 2015, previously published on April 20, 2015
The Financial Conduct Authority has implemented several relatively small changes to the Listing, Prospectus and Disclosure and Transparency Rules. These largely clarify existing rules and update and correct guidance.

 

HTMLRetail Tracking Firm Slammed with FTC Consent Order
Kenneth R. Florin, Ieuan Jolly, David G. Mallen, James D. Taylor; Loeb & Loeb LLP;
Legal Alert/Article
May 19, 2015, previously published on May 2015
The Federal Trade Commission last month announced a proposed consent order settling claims against Nomi Technologies, a third-party mobile tracking service that collects data about consumers' in-store shopping behavior. The FTC's case against Nomi is significant, but not for involving a...

 

HTMLFDA Rejects Otsuka’s Assertions of Orphan Exclusivity for Abilify, Allowing Generics to Proceed
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The impact of the FDA’s decision is that several companies will be allowed to enter the market with generic aripiprazole, although the generics must carve out the use of the drug for treating pediatric Tourette’s Disorder from their labeling and marketing while the exclusivity period...

 

HTMLFDA Finalizes Three Guidance Documents on Biosimilars
Edgar J. Asebey, Maureen Bennett, Christian B. Fulda, Colleen Heisey, Christopher M. Mikson; Jones Day;
Legal Alert/Article
May 15, 2015, previously published on May 2015
FDA recently finalized three draft guidance documents addressing scientific and regulatory issues associated with the development and licensure of biosimilars.

 

HTMLKodak’s Pricing Policy for Printer Parts and Ink Gets Jammed By the Sixth Circuit
Irving Scher; Greenberg Traurig, LLP;
Legal Alert/Article
May 15, 2015, previously published on May 12, 2015
On March 16, 2015, in Collins Inkjet Corp. v. Eastman Kodak Co.,1 the Sixth Circuit became the first court of appeals to adopt a cost-based test for determining when a supplier’s differential pricing policy for joint sales of two products constitutes an “economic” tying claim that...

 

HTMLGuidance Explains How The FDA Will Define and Process Submissions for Changes to Risk Management Plans
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The regulator issued guidance on changes to approved risk evaluation and mitigation strategies (REMS), distinguishing “modifications” from “revisions,” and explaining how these should be submitted and how the FDA will review and act on them.

 

HTMLOPDP to Study The Impact of Comparative Pricing Information in DTC and Professional Prescription Ads
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The agency will investigate how prescription drug product perceptions are impacted by the inclusion of price comparison information and supplementary contextual information in advertising geared at consumers and health care professionals, amid concern that the impression remains that price is the...

 

HTMLEU Approach to Information Sharing: CJEU ruling in Banana Cartel
Teresa Charatjan; Greenberg Traurig, LLP;
Legal Alert/Article
May 15, 2015, previously published on May 12, 2015
Information exchanges between competitors is a highly topical issue under EU competition law. The recent judgment of the Court of Justice of the EU (CJEU), the highest EU court, confirmed its significance when it recently ruled that a bilateral exchange between banana importers of pre-pricing...

 

HTMLFDA Issues Guidance Documents on How It Considers Balancing Premarket and Postmarket Data Collection During PMA Reviews in a Bid to Accelerate the Approval of New Breakthrough Devices
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The regulator explains how it determines when it’s appropriate to increase reliance on postmarket collection to reduce the extent of premarket collection to support premarket approval, in a document integral to the CDRH’s risk-based approach to regulation and the FDA’s broader...

 


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