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…(mmccorm1@corus.jnj.com), Vice-Chair Freddie K. Park (freddiep99@yahoo.com), or Kurt R. Karst (kkarst@hpm.com) if you are interested in becoming a member of the Special Committee on the FDA and the Hatch-Waxman Subcommittee….
…Delaware [Teva Pharmaceuticals USA Inc., Teva Pharmaceutical Industries Ltd., Teva Neuroscience, Inc., and Yeda Research and Development Co. Ltd. v. Mylan Pharmaceuticals Inc., Mylan Inc. and Natco Pharma Ltd., Civil…
…It involved Gree Electric Appliances Inc. of Zhuhai, Hong Kong, Gree Electric Appliances Sales Co. Ltd., and Gree USA Inc. (the “Gree Companies”), an appliance manufacturer and two of its…
…from the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius. In that case, a 3-judge panel of the D.C. Circuit ruled in a 2-1 decision…
…Circuit decision in Teva Pharms. USA, Inc. v. Eisai Co. Ltd., Case No. 2009-1593 (Fed. Cir. Oct. 6, 2010), in which the Court ruled that a subsequent Paragraph IV filer…
…Pharms. USA, Inc. v. Eisai Co., 620 F.3d 1341 (Fed. Cir. 2010), for establishing jurisdiction. LEXAPRO Tablets is currently listed in FDA’s Orange Book with three patents: U.S. Patent Nos….
…Warning Letter to Homeolab USA Inc. (part of the parent company, Homeocan Inc. located in Montreal, Québec) for, among other things, impeding the FDA inspection by preventing the investigator from…
…prices and promises a strategy “for equitable drug pricing reform through competition, innovation, and transparency.” The actual policy proposals read like a wish list. It outlines a host of legislative…
…Recalls Recalls hit a five-year peak in 2022. OPQ reported that 166 catalog sites generated 912 recalls. Four specific kinds of events comprised over a third of the 900+ recalls….
…include soap. [(Emphasis added)] Hain argued that soap should be given the common and usual lay person’s meaning, i.e., anything that foams and cleanses. However, such a broad definition would…
…found in over-the-counter cold and allergy medications and a primary ingredient in clandestinely manufactured methamphetamine. U.S. Gov’t Accountability Office, GAO-13-204, Drug Control: State Approaches to Control Access to Key Methamphetamine…
…reproductive toxicity, and hormonal effects, are missing. Comments are due October 28, 2015. FDA explains that it provides a longer comments period (i.e., 180 days) because of the complexity of…
…a “Workshop” to examine advertising for over-the-counter (OTC) homeopathic products on September 21. FDA’s Federal Register Notice for the hearing identified issues to be discussed that were careful to avoid…
…week, FTC staff announced that it has submitted a comment to FDA. The comment was approved by the Commission by a vote of 5-0. Not surprisingly, FTC staff takes the…
…ruled in Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010) and Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009), that the U.S. Supreme Court’s March 2009…