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…heart disease, and diabetes to pay $70 million in consumer redress. The court’s order dated August 13, 2009 did not come until more than 6 years after the date of…
…e.g., In re POM Wonderful, LLC, 155 F.T.C. 1 (2013), aff’d as modified, 777 F.3d 478 (D.C. Cir. 2015) (FTC order clarifying policy on health claim substantiation); In re 1-800…
…with false and misleading advertising because POM’s claims that POM’s products (POM Wonderful 100% pomegranate juice, POMx Pills, and POMx Liquid) prevent, reduce the risk of, or treat heart disease,…
…the company’s Motion for a Temporary Restraining Order and Preliminary Injunction is under seal, so there’s not a lot for us to go on. The Complaint does reference, however, a…
…proffered as support and the representation at issue at the time it is made, and the representation is supported by competent and reliable scientific evidence, including tests, analysis, research, and…
…found FDA’s August 18, 2014 Letter Decision permitting the approval of ANDAs for generic PRECEDEX not arbitrary, capricious, or otherwise not in accordance with law, but rather, a decision based…
…pursuant to an Order issued under 35 U.S.C. § 271(e)(4), permanently enjoined from “engaging in the commercial manufacture, use, offer to sell or sale within the United States, or importation…
…has filed over the past few years, including Docket Nos. FDA-2008-P-0529, FDA-2009-P-0555, FDA-2010-P-0642, FDA-2012-P-0555, FDA-2013-P-0025. In each instance (except for one petition that was apparently withdrawn – FDA-2013-P-1128), FDA has…
…treat various medical conditions. The intervenor prescriber asserted that, as a consequence of his patient population, he prescribes more scheduled substances than typical doctors. Nevertheless, DEA had interviewed and investigated…
…seeking “information on and examples of appropriate uses of the custom device exemption.” 77 Fed. Reg. 69,488, 69,488 (Nov. 19, 2012). In particular, FDA is seeking information related to instances…
…it. The expanded role of pharmacies, distributors and manufacturers as controlled substance gatekeepers is a continuously evolving one. As the lawmakers’ letter asserts, improved communication between DEA and pharmacies, distributors…
…order FDA to issue the regulations “as soon as reasonably practicable” pursuant to a court-ordered timeline, and to order OMB to approve the regulations and “cease interfering with FDA’s promulgation”…
By Jennifer D. Newberger – On January 31, 2012, Rep. Edward Markey (D-MA) introduced H.R. 3847, the “Safety of Untested and New Devices Act of 2012,” also known as the…
…that a tobacco product was commercially marketed in the United States as of February 15, 2007, i.e., that the product was commercially marketed in the United States on February 15,…
…tobacco product with the predicate tobacco product with respect to all product characteristics. These include design features (components, subcomponents, specifications, etc.), a listing of ingredients (ingredient names, common names, the…